Pramlintide Acetate Injection (Symlin)
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Pramlintide Acetate Injection (Symlin)

SYMLIN®
(pramlintide acetate) Injection

WARNING

SYMLIN (pramlintide acetate injection) is used with insulin and has been associated with an increased risk of insulin-induced severe hypoglycemia, particularly in patients with type 1 diabetes. When severe hypoglycemia associated with SYMLIN (pramlintide acetate injection) use occurs, it is seen within 3 hours following a SYMLIN (pramlintide acetate injection) injection. If severe hypoglycemia occurs while operating a motor vehicle, heavy machinery, or while engaging in other high-risk activities, serious injuries may occur. Appropriate patient selection, careful patient instruction, and insulin dose adjustments are critical elements for reducing this risk.

DRUG DESCRIPTION

SYMLIN® (pramlintide acetate) Injection is an antihyperglycemic drug for use in patients with diabetes treated with insulin. Pramlintide is a synthetic analog of human amylin, a naturally occurring neuroendocrine hormone synthesized by pancreatic beta cells that contributes to glucose control during the postprandial period. Pramlintide is provided as an acetate salt of the synthetic 37-amino acid polypeptide, which differs in amino acid sequence from human amylin by replacement with proline at positions 25 (alanine), 28 (serine), and 29 (serine).

The structural formula of pramlintide acetate is as shown:


Lys-Cys-Asn-Thr-Ala-Thr-Cys-Ala-Thr-Gln-Arg-Leu-Ala-Asn-Phe- Leu-Val-His-Ser-Ser-Asn-Asn-Phe-Gly-Pro-Ile-Leu-Pro-Pro-Thr- Asn-Val-Gly-Ser-Asn-Thr-Tyr-NH2 acetate (salt) with a disulfide bridge between the two Cys residues.

Pramlintide acetate is a white powder that has a molecular formula of C171H267N51O53S2· x C2H4O2 (3< x <8); the molecular weight is 3949.4. Pramlintide acetate is soluble in water.

SYMLIN (pramlintide acetate injection) is formulated as a clear, isotonic, sterile solution for subcutaneous (SC) administration. SYMLIN (pramlintide acetate injection) vials contain 0.6 mg/mL of pramlintide (as acetate), 2.25 mg/mL of metacresol as a preservative, D-mannitol as a tonicity modifier, and acetic acid and sodium acetate as pH modifiers. SYMLIN (pramlintide acetate injection) has a pH of approximately 4.0.

What are the possible side effects of pramlintide (Symlin, SymlinPen 120, SymlinPen 60)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • severe nausea that lasts for 3 to 7 days; or
  • more frequent high blood sugar levels.

Less serious side effects may include:

  • runny or stuffy nose, sore throat, cough;
  • nausea, loss of appetite;
  • headache, tired feeling; or
  • joint pain.

This is not a...

Read All Potential Side Effects and See Pictures of Symlin »

What are the precautions when taking pramlintide acetate injection (Symlin)?

Before using pramlintide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as the preservative metacresol), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medication, consult your doctor or pharmacist if you have: stomach/intestinal disorders (e.g., digestion problems such as gastroparesis).

This medication should not be used by people who are unable to tell when they have symptoms of low blood sugar (e.g., children).

Before using pramlintide, tell your doctor or pharmacist your medical history, especially of: attacks of low blood...

Read All Potential Precautions of Symlin »

Last reviewed on RxList: 4/9/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

SYMLIN (pramlintide acetate injection) is given at mealtimes and is indicated for:

  • Type 1 diabetes, as an adjunct treatment in patients who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy.
  • Type 2 diabetes, as an adjunct treatment in patients who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy, with or without a concurrent sulfonylurea agent and/or metformin.

DOSAGE AND ADMINISTRATION

SYMLIN (pramlintide acetate injection) dosage differs depending on whether the patient has type 2 or type 1 diabetes (see below). When initiating therapy with SYMLIN (pramlintide acetate injection) , initial insulin dose reduction is required in all patients (both type 2 and type 1) to reduce the risk of insulin-induced hypoglycemia. As this reduction in insulin can lead to glucose elevations, patients should be monitored at regular intervals to assess SYMLIN (pramlintide acetate injection) tolerability and the effect on blood glucose, so that individualized insulin adjustments can be initiated. If SYMLIN (pramlintide acetate injection) therapy is discontinued for any reason (e.g., surgery or illnesses), the same initiation protocol should be followed when SYMLIN (pramlintide acetate injection) therapy is re-instituted (see below).

Initiation of SYMLIN (pramlintide acetate injection) therapy

Patients With Insulin-using Type 2 Diabetes

In patients with insulin-using type 2 diabetes, SYMLIN (pramlintide acetate injection) should be initiated at a dose of 60 mcg and increased to a dose of 120 mcg as tolerated.

Patients should be instructed to:

  • Initiate SYMLIN (pramlintide acetate injection) at 60 mcg subcutaneously, immediately prior to major meals;
  • Reduce preprandial, rapid-acting or short-acting insulin dosages, including fixed-mix insulins (70/30) by 50%;
  • Monitor blood glucose frequently, including pre- and post-meals and at bedtime;
  • Increase the SYMLIN (pramlintide acetate injection) dose to 120 mcg when no clinically significant nausea has occurred for 3-7 days. SYMLIN (pramlintide acetate injection) dose adjustments should be made only as directed by the health care professional. If significant nausea persists at the 120 mcg dose, the SYMLIN (pramlintide acetate injection) dose should be decreased to 60 mcg;
  • Adjust insulin doses to optimize glycemic control once the target dose of SYMLIN (pramlintide acetate injection) is achieved and nausea (if experienced) has subsided. Insulin dose adjustments should be made only as directed by the health care professional;
  • Contact a health care professional skilled in the use of insulin to review SYMLIN (pramlintide acetate injection) and insulin dose adjustments at least once a week until a target dose of SYMLIN (pramlintide acetate injection) is achieved, SYMLIN (pramlintide acetate injection) is well-tolerated, and blood glucose concentrations are stable.
Patients With Type 1 Diabetes

In patients with type 1 diabetes, SYMLIN (pramlintide acetate injection) should be initiated at a dose of 15 mcg and titrated at 15-mcg increments to a maintenance dose of 30 mcg or 60 mcg as tolerated.

Patients should be instructed to:

  • Initiate SYMLIN (pramlintide acetate injection) at a starting dose of 15 mcg subcutaneously, immediately prior to major meals;
  • Reduce preprandial, rapid-acting or short-acting insulin dosages, including fixed-mix insulins (e.g., 70/30) by 50%;
  • Monitor blood glucose frequently, including pre- and post-meals and at bedtime;
  • Increase the SYMLIN (pramlintide acetate injection) dose to the next increment (30 mcg, 45 mcg, or 60 mcg) when no clinically significant nausea has occurred for at least 3 days. SYMLIN (pramlintide acetate injection) dose adjustments should be made only as directed by the health care professional. If significant nausea persists at the 45- or 60-mcg dose level, the SYMLIN (pramlintide acetate injection) dose should be decreased to 30 mcg. If the 30-mcg dose is not tolerated, discontinuation of SYMLIN (pramlintide acetate injection) therapy should be considered;
  • Adjust insulin doses to optimize glycemic control once the target dose of SYMLIN (pramlintide acetate injection) is achieved and nausea (if experienced) has subsided. Insulin dose adjustments should be made only as directed by the health care professional;
  • Contact a health care professional skilled in the use of insulin to review SYMLIN (pramlintide acetate injection) and insulin dose adjustments at least once a week until a target dose of SYMLIN (pramlintide acetate injection) is achieved, SYMLIN (pramlintide acetate injection) is well-tolerated, and blood glucose concentrations are stable.
Once Target Dose of SYMLIN (pramlintide acetate injection) Is Achieved in Type 2 or Type 1 Patients

After a maintenance dose of SYMLIN (pramlintide acetate injection) is achieved, both insulin-using patients with type 2 diabetes and patients with type 1 diabetes should be instructed to:

  • Adjust insulin doses to optimize glycemic control once the target dose of SYMLIN (pramlintide acetate injection) is achieved and nausea (if experienced) has subsided. Insulin dose adjustments should be made only as directed by a health care professional;
  • Contact a health care professional in the event of recurrent nausea or hypoglycemia. An increased frequency of mild to moderate hypoglycemia should be viewed as a warning sign of increased risk for severe hypoglycemia.
Administration

SYMLIN (pramlintide acetate injection) should be administered subcutaneously immediately prior to each major meal ( ≥ 250 kcal or containing ≥ 30 g of carbohydrate).

SYMLIN (pramlintide acetate injection) should be at room temperature before injecting to reduce potential injection site reactions. Each SYMLIN (pramlintide acetate injection) dose should be administered subcutaneously into the abdomen or thigh (administration into the arm is not recommended because of variable absorption). Injection sites should be rotated so that the same site is not used repeatedly. The injection site selected should also be distinct from the site chosen for any concomitant insulin injection.

  • SYMLIN (pramlintide acetate injection) and insulin should always be administered as separate injections.
  • SYMLIN (pramlintide acetate injection) should not be mixed with any type of insulin.
  • If a SYMLIN (pramlintide acetate injection) dose is missed, wait until the next scheduled dose and administer the usual amount.

Symlin (pramlintide acetate injection) Pen™ pen-injector

The Symlin (pramlintide acetate injection) Pen™ pen-injector is available in two presentations:

  • Symlin (pramlintide acetate injection) Pen™ 60 pen-injector for doses of 15 mcg, 30 mcg, 45 mcg and 60 mcg
  • Symlin (pramlintide acetate injection) Pen™ 120 pen-injector for doses of 60 mcg and 120 mcg

See the accompanying Patient Instructions for Use for instructions for using the Symlin (pramlintide acetate injection) Pen™ pen-injector.

The patient should be advised:

  • to confirm they are using the correct pen-injector that will deliver their prescribed dose
  • on proper use of the pen-injector, emphasizing how and when to set up a new pen-injector
  • not to transfer SYMLIN (pramlintide acetate injection) from the pen-injector to a syringe. Doing so could result in a higher dose than intended, because SYMLIN (pramlintide acetate injection) in the pen-injector is a higher concentration than SYMLIN (pramlintide acetate injection) in the SYMLIN (pramlintide acetate injection) vial
  • not to share the pen-injector and needles with others
  • that needles are not included with the pen-injector and must be purchased separately
  • which needle length and gauge should be used
  • to use a new needle for each injection.

SYMLIN (pramlintide acetate injection) vials

To administer SYMLIN (pramlintide acetate injection) from vials, use a U-100 insulin syringe (preferably a 0.3 mL [0.3 cc] size) for optimal accuracy. If using a syringe calibrated for use with U-100 insulin, use the chart below (Table 8) to measure the microgram dosage in unit increments.

Table 8: Conversion of SYMLIN (pramlintide acetate injection) Dose to Insulin Unit Equivalents

Dosage Prescribed
(mcg)
Increment Using a U-100 Syringe
(Units)
Volume
(cc or mL)
15 0.025
30 5 0.05
45 0.075
60 10 0.1
120 20 0.2

Always use separate, new syringes and needles to give SYMLIN (pramlintide acetate injection) and insulin injections.

Discontinuation of Therapy

SYMLIN (pramlintide acetate injection) therapy should be discontinued if any of the following occur:

  • Recurrent unexplained hypoglycemia that requires medical assistance;
  • Persistent clinically significant nausea;
  • Noncompliance with self-monitoring of blood glucose concentrations;
  • Noncompliance with insulin dose adjustments;
  • Noncompliance with scheduled health care professional contacts or recommended clinic visits.

Preparation and Handling

SYMLIN (pramlintide acetate injection) should be inspected visually for particulate matter or discoloration prior to administration whenever the solution and the container permit.

HOW SUPPLIED

SYMLIN (pramlintide acetate injection) is supplied as a sterile injection in the following dosage forms:

  • 1.5 mL disposable multidose Symlin (pramlintide acetate injection) Pen™ 60 pen-injector containing 1000 mcg/mL pramlintide (as acetate).
  • 2.7 mL disposable multidose Symlin (pramlintide acetate injection) Pen™ 120 pen-injector containing 1000 mcg/mL pramlintide (as acetate).
  • 5 mL vial, containing 600 mcg/mL pramlintide (as acetate), for use with an insulin syringe.

To administer SYMLIN (pramlintide acetate injection) from vials, use a U-100 insulin syringe (preferably a 0.3 mL [0.3 cc] size). If using a syringe calibrated for use with U-100 insulin, use the chart (Table 8) in the DOSAGE AND ADMINISTRATION section to measure the microgram dosage in unit increments.

Do not mix SYMLIN (pramlintide acetate injection) with insulin.

SYMLIN (pramlintide acetate injection) Injection is available in the following package sizes:

Symlin (pramlintide acetate injection) Pen™ 60 pen-injector, containing 1000 mcg/mL pramlintide (as acetate) 2 X 1.5 mL disposable multidose pen-injector...............................(NDC 66780-111-08)

Symlin (pramlintide acetate injection) Pen™ 120 pen-injector, containing 1000 mcg/mL pramlintide (as acetate) 2 X 2.7 mL disposable multidose pen-injector...............................(NDC 66780-111-09)

5 mL vial, containing 600 mcg/mL pramlintide (as acetate), for use with an insulin syringe...............................(NDC 66780-110-01)

Storage

SYMLIN (pramlintide acetate injection) pen-injectors and vials not in use: Refrigerate (36°F to 46°F; 2°C to 8°C), and protect from light. Do not freeze. Do not use if product has been frozen. Unused SYMLIN (pramlintide acetate injection) (opened or unopened) should not be used after the expiration (EXP) date printed on the carton and the label.

SYMLIN (pramlintide acetate injection) pen-injectors and vials in use: After first use, refrigerate or keep at a temperature not greater than 86°F (30°C) for 30 days. Use within 30 days, whether or not refrigerated.

Storage conditions are summarized in Table 9:

Table 9: Storage Conditions

Dosage Form Unopened (not in use)
Refrigerated
Open (in use)
Refrigerated or Temperature Up To 86°F (30°C)
1.5 mL pen-injector
2.7 mL pen-injector
5 mL vial
Until Expiration Date Use Within 30 Days

The Symlin (pramlintide acetate injection) Pen™ pen-injectors and SYMLIN (pramlintide acetate injection) vials are manufactured for: Amylin Pharmaceuticals, Inc. San Diego, CA 92121 USA http://www.SYMLIN (pramlintide acetate injection) .com. FDA rev date: 9/25/2007

Last reviewed on RxList: 4/9/2008
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Adverse events (excluding hypoglycemia, discussed below) commonly associated with SYMLIN (pramlintide acetate injection) when co-administered with a fixed dose of insulin in the long-term, placebo-controlled trials in insulin-using type 2 patients and type 1 patients are presented in Table 4 and Table 5, respectively. The same adverse events were also shown in the open-label clinical practice study, which employed flexible insulin dosing.

Table 4: Treatment-Emergent Adverse Events Occurring With ≥ 5% Incidence and Greater Incidence With SYMLIN (pramlintide acetate injection) Compared With Placebo in Long-Term, Placebo-Controlled Trials. Incidence of the Same Events in the Open-Label Clinical Practice Study (Patients With Insulin-Using Type 2 Diabetes, 120 mcg)

  Long-Term, Placebo-Controlled Studies Open-Label, Clinical Practice Study
  Placebo + Insulin
(n(%))
(N=284)
SYMLIN (pramlintide acetate injection) + Insulin
(n(%))
(N=292)
SYMLIN (pramlintide acetate injection) + Insulin
(n(%))
(N=166)
Nausea 34 (12) 81 (28) 53 (30)
Headache 19 (7) 39 (13) 8 (5)
Anorexia 5 (2) 27 (9) 1 (<1)
Vomiting 12 (4) 24 (8) 13 (7)
Abdominal Pain 19 (7) 23 (8) 3 (2)
Fatigue 11 (4) 20 (7) 5 (3)
Dizziness 11 (4) 17 (6) 3 (2)
Coughing 12 (4) 18 (6) 4 (2)
Pharyngitis 7 (2) 15 (5) 6 (3)

Table 5: Treatment-Emergent Adverse Events Occurring With ≥ 5% Incidence and Greater Incidence with SYMLIN (pramlintide acetate injection) Compared to Placebo in Long-Term, Placebo-Controlled Studies. Incidence of the Same Events in the Open-Label Clinical Practice Study (Patients With Type 1 Diabetes, 30 or 60 mcg)

  Long-Term, Placebo-Controlled Studies Open-Label, Clinical Practice Study
  Placebo + Insulin
(n(%))
(N=538)
SYMLIN (pramlintide acetate injection) + Insulin
(n(%))
(N=716)
SYMLIN (pramlintide acetate injection) + Insulin
(n(%))
(N=265)
Nausea 92 (17) 342 (48) 98 (37)
Anorexia 12 (2) 122 (17) 0 (0)
Inflicted Injury 55 (10) 97 (14) 20 (8)
Vomiting 36 (7) 82 (11) 18 (7)
Arthralgia 27 (5) 51 (7) 6 (2)
Fatigue 22 (4) 51 (7) 12 (4.5)
Allergic Reaction 28 (5) 41 (6) 1 (<1)
Dizziness 21 (4) 34 (5) 5 (2)

Most adverse events were gastrointestinal in nature. In patients with type 2 or type 1 diabetes, the incidence of nausea was higher at the beginning of SYMLIN (pramlintide acetate injection) treatment and decreased with time in most patients. The incidence and severity of nausea are reduced when SYMLIN (pramlintide acetate injection) is gradually titrated to the recommended doses (see DOSAGE AND ADMINISTRATION).

Severe Hypoglycemia

SYMLIN (pramlintide acetate injection) alone (without the concomitant administration of insulin) does not cause hypoglycemia. However, SYMLIN (pramlintide acetate injection) is indicated as an adjunct treatment in patients who use mealtime insulin therapy and co-administration of SYMLIN (pramlintide acetate injection) with insulin can increase the risk of insulin-induced hypoglycemia, particularly in patients with type 1 diabetes (see BOXED WARNING). The incidence of severe hypoglycemia during the SYMLIN (pramlintide acetate injection) clinical development program is summarized in Table 6 and Table 7.

Table 6: Incidence and Event Rate of Severe Hypoglycemia in Long-Term, Placebo-Controlled and Open-Label, Clinical Practice Studies in Patients With Insulin-Using Type 2 Diabetes

  Long-Term, Placebo-Controlled Studies (No Insulin Dose-Reduction During Initiation) Open-Label, Clinical Practice Study (Insulin Dose-Reduction During Initiation)
  Placebo + Insulin SYMLIN + Insulin SYMLIN + Insulin
Severe Hypoglycemia 0-3 Months
(n=284)
>3-6 Months
(n=251)
0-3 Months
(n=292)
>3-6 Months
(n=255)
0-3 Months
(n=166)
>3-6 Months
(n=150)
Patient-Ascertained*
  Event Rate (event rate/patient year) 0.24 0.13 0.45 0.39 0.05 0.03
  Incidence (%) 2.1 2.4 8.2 4.7 0.6 0.7
Medically Assisted**
  Event Rate (event rate/patient year) 0.06 0.07 0.09 0.02 0.05 0.03
  Incidence (%) 0.7 1.2 1.7 0.4 0.6 0.7
* Patient-ascertained severe hypoglycemia: Requiring the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or requiring the administration of glucagon injection, intravenous glucose, or other medical intervention.
** Medically assisted severe hypoglycemia: Requiring glucagon, IV glucose, hospitalization, paramedic assistance, emergency room visit, and/or assessed as an SAE by the investigator.

Table 7: Incidence and Event Rate of Severe Hypoglycemia in Long-Term, Placebo-Controlled and Open-Label, Clinical Practice Studies in Patients With Type 1 Diabetes

  Long-Term, Placebo-Controlled Studies (No Insulin Dose-Reduction During Initiation) Open-Label,Clinical PracticeStudy (Insulin Dose-Reduction During Initiation)
  Placebo + Insulin SYMLIN + Insulin SYMLI N + Insulin
Severe Hypoglycemia 0-3 Months
(n=538)
>3-6 Months
(n=470)
0-3 Months
(n=716)
>3-6 Months
(n=576)
0-3 Months
(n=265)
>3-6 Months
(n=213)
Patient-Ascertained*
  Event Rate (event rate/patient year) 1.33 1.06 1.55 0.82 0.29 0.16
  Incidence (%) 10.8 8.7 16.8 11.1 5.7 3.8
Medically Assisted**
  Event Rate (event rate/patient year) 0.19 0.24 0.50 0.27 0.10 0.04
  Incidence (%) 3.3 4.3 7.3 5.2 2.3 0.9
* Patient-ascertained severe hypoglycemia: Requiring the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or requiring the administration of glucagon injection, intravenous glucose, or other medical intervention.
** Medically assisted severe hypoglycemia: Requiring glucagon, IV glucose, hospitalization, paramedic assistance, emergency room visit, and/or assessed as an SAE by the investigator.

Read the Symlin (pramlintide acetate injection) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Due to its effects on gastric emptying, SYMLIN (pramlintide acetate injection) therapy should not be considered for patients taking drugs that alter gastrointestinal motility (e.g., anticholinergic agents such as atropine) and agents that slow the intestinal absorption of nutrients (e.g., α-glucosidase inhibitors). Patients using these drugs have not been studied in clinical trials.

SYMLIN (pramlintide acetate injection) has the potential to delay the absorption of concomitantly administered oral medications. When the rapid onset of a concomitant orally administered agent is a critical determinant of effectiveness (such as analgesics), the agent should be administered at least 1 hour prior to or 2 hours after SYMLIN (pramlintide acetate injection) injection.

In clinical trials, the concomitant use of sulfonylureas or biguanides did not alter the adverse event profile of SYMLIN (pramlintide acetate injection) . No formal interaction studies have been performed to assess the effect of SYMLIN (pramlintide acetate injection) on the kinetics of oral antidiabetic agents.

Mixing SYMLIN (pramlintide acetate injection) and Insulin

The pharmacokinetic parameters of SYMLIN (pramlintide acetate injection) were altered when mixed with regular, NPH, and 70/30 premixed formulations of recombinant human insulin immediately prior to injection. Thus, SYMLIN (pramlintide acetate injection) and insulin should not be mixed and must be administered separately.

Last reviewed on RxList: 4/9/2008
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Patient Selection

Proper patient selection is critical to safe and effective use of SYMLIN (pramlintide acetate injection) . Before initiation of therapy, the patient's HbA1c, recent blood glucose monitoring data, history of insulin-induced hypoglycemia, current insulin regimen, and body weight should be reviewed. SYMLIN (pramlintide acetate injection) therapy should only be considered in patients with insulin-using type 2 or type 1 diabetes who fulfill the following criteria:

  • have failed to achieve adequate glycemic control despite individualized insulin management;
  • are receiving ongoing care under the guidance of a health care professional skilled in the use of insulin and supported by the services of diabetes educator(s).

Patients meeting any of the following criteria should NOT be considered for SYMLIN (pramlintide acetate injection) therapy:

Hypoglycemia. SYMLIN (pramlintide acetate injection) alone does not cause hypoglycemia. However, SYMLIN (pramlintide acetate injection) is indicated to be co-administered with insulin therapy and in this setting SYMLIN (pramlintide acetate injection) increases the risk of insulin-induced severe hypoglycemia, particularly in patients with type 1 diabetes. Severe hypoglycemia associated with SYMLIN (pramlintide acetate injection) occurs within the first 3 hours following a SYMLIN (pramlintide acetate injection) injection. If severe hypoglycemia occurs while operating a motor vehicle, heavy machinery, or while engaging in other high-risk activities, serious injuries may occur. Therefore, when introducing SYMLIN (pramlintide acetate injection) therapy, appropriate precautions need to be taken to avoid increasing the risk for insulin-induced severe hypoglycemia. These precautions include frequent pre- and post-meal glucose monitoring combined with an initial 50% reduction in pre-meal doses of short-acting insulin (see DOSAGE AND ADMINISTRATION).

Symptoms of hypoglycemia may include hunger, headache, sweating, tremor, irritability, or difficulty concentrating. Rapid reductions in blood glucose concentrations may induce such symptoms regardless of glucose values. More severe symptoms of hypoglycemia include loss of consciousness, coma, or seizure.

Early warning symptoms of hypoglycemia may be different or less pronounced under certain conditions, such as long duration of diabetes; diabetic nerve disease; use of medications such as beta-blockers, clonidine, guanethidine, or reserpine; or intensified diabetes control.

The addition of any antihyperglycemic agent such as SYMLIN (pramlintide acetate injection) to an existing regimen of one or more anti-hyperglycemic agents (e.g., insulin, sulfonylurea), or other agents that can increase the risk of hypoglycemia may necessitate further insulin dose adjustments and particularly close monitoring of blood glucose.

The following are examples of substances that may increase the blood glucose-lowering effect and susceptibility to hypoglycemia: oral anti-diabetic products, ACE inhibitors, diisopyramide, fibrates, fluoxetine, MAO inhibitors, pentoxifylline, propoxyphene, salicylates, and sulfonamide antibiotics.

Clinical studies employing a controlled hypoglycemic challenge have demonstrated that SYMLIN (pramlintide acetate injection) does not alter the counter-regulatory hormonal response to insulin-induced hypoglycemia. Likewise, in SYMLIN (pramlintide acetate injection) -treated patients, the perception of hypoglycemic symptoms was not altered with plasma glucose concentrations as low as 45 mg/dL.

PRECAUTIONS

General

Hypoglycemia (See WARNINGS).

SYMLIN (pramlintide acetate injection) should be prescribed with caution to persons with visual or dexterity impairment.

Information for Patients

Health care providers should inform patients of the potential risks and advantages of SYMLIN (pramlintide acetate injection) therapy. Health care providers should also inform patients about self-management practices including glucose monitoring, proper injection technique, timing of dosing, and proper storage of SYMLIN (pramlintide acetate injection) . In addition, reinforce the importance of adherence to meal planning, physical activity, recognition and management of hypoglycemia and hyperglycemia, and assessment of diabetes complications. Refer patients to the SYMLIN Medication Guide and Patient Instructions for Use for additional information.

Instruct patients on handling of special situations such as intercurrent conditions (illness or stress), an inadequate or omitted insulin dose, inadvertent administration of increased insulin or SYMLIN (pramlintide acetate injection) dose, inadequate food intake or missed meals.

SYMLIN (pramlintide acetate injection) and insulin should always be administered as separate injections and never be mixed.

Women with diabetes should be advised to inform their healthcare professional if they are pregnant or contemplating pregnancy.

Renal Impairment: The dosing requirements for SYMLIN (pramlintide acetate injection) are not altered in patients with moderate or severe renal impairment (ClCr >20 to ≤ 50 mL/min). No studies have been done in dialysis patients (see CLINICAL PHARMACOLOGY; Special Populations).

Hepatic Impairment: Studies have not been performed in patients with hepatic impairment. However, hepatic dysfunction is not expected to affect blood concentrations of SYMLIN (see CLINICAL PHARMACOLOGY; Special Populations).

Allergy: Local allergy. Patients may experience redness, swelling, or itching at the site of injection. These minor reactions usually resolve in a few days to a few weeks. In some instances, these reactions may be related to factors other than SYMLIN (pramlintide acetate injection) , such as irritants in a skin cleansing agent or improper injection technique.

Systemic Allergy. In controlled clinical trials up to 12 months, potential systemic allergic reactions were reported in 65 (5%) of type 2 patients and 59 (5%) of type 1 SYMLIN (pramlintide acetate injection) -treated patients. Similar reactions were reported by 18 (4%) and 28 (5%) of placebo-treated type 2 and type 1 patients, respectively. No patient receiving SYMLIN (pramlintide acetate injection) was withdrawn from a trial due to a potential systemic allergic reaction.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis. A two-year carcinogenicity study was conducted in CD-1 mice with doses of 0.2, 0.5, and 1.2 mg/kg/day of SYMLIN (pramlintide acetate injection) (32, 67, and 159 times the exposure resulting from the maximum recommended human dose based on area under the plasma concentration curve or AUC, respectively). No drug-induced tumors were observed. A two-year carcinogenicity study was conducted in Sprague-Dawley rats with doses of 0.04, 0.2, and 0.5 mg/kg/day of SYMLIN (pramlintide acetate injection) (3, 9, and 25 times the exposure resulting from the maximum recommended human dose based on AUC, respectively). No drug-induced tumors were observed in any organ.

Mutagenesis. SYMLIN (pramlintide acetate injection) was not mutagenic in the Ames test and did not increase chromosomal aberration in the human lymphocytes assay. SYMLIN (pramlintide acetate injection) was not clastogenic in the in vivo mouse micronucleus test or in the chromosomal aberration assay utilizing Chinese hamster ovary cells.

Impairment of Fertility. Administration of 0.3, 1, or 3 mg/kg/day of SYMLIN (pramlintide acetate injection) (8, 17, and 82 times the exposure resulting from the maximum recommended human dose based on body surface area) had no significant effects on fertility in male or female rats. The highest dose of 3 mg/kg/day resulted in dystocia in 8/12 female rats secondary to significant decreases in serum calcium levels.

Pregnancy

Teratogenic Effects: Pregnancy Category C. No adequate and well-controlled studies have been conducted in pregnant women. Studies in perfused human placenta indicate that SYMLIN (pramlintide acetate injection) has low potential to cross the maternal/fetal placental barrier. Embryofetal toxicity studies with SYMLIN (pramlintide acetate injection) have been performed in rats and rabbits. Increases in congenital abnormalities (neural tube defect, cleft palate, exencephaly) were observed in fetuses of rats treated during organogenesis with 0.3 and 1.0 mg/kg/day (10 and 47 times the exposure resulting from the maximum recommended human dose based on AUC, respectively). Administration of doses up to 0.3 mg/kg/day SYMLIN (pramlintide acetate injection) (9 times maximum recommended dose based on AUC) to pregnant rabbits had no adverse effects in embryofetal development; however, animal reproduction studies are not always predictive of human response. SYMLIN (pramlintide acetate injection) should be used during pregnancy only if it is determined by the healthcare professional that the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is unknown whether SYMLIN (pramlintide acetate injection) is excreted in human milk. Many drugs, including peptide drugs, are excreted in human milk. Therefore, SYMLIN (pramlintide acetate injection) should be administered to nursing women only if it is determined by the health care professional that the potential benefit outweighs the potential risk to the infant.

Pediatric Use

Safety and effectiveness of SYMLIN (pramlintide acetate injection) in pediatric patients have not been established.

Geriatric Use

SYMLIN (pramlintide acetate injection) has been studied in patients ranging in age from 15 to 84 years of age, including 539 patients 65 years of age or older. The change in HbA1c values and hypoglycemia frequencies did not differ by age, but greater sensitivity in some older individuals cannot be ruled out. Thus, both SYMLIN (pramlintide acetate injection) and insulin regimens should be carefully managed to obviate an increased risk of severe hypoglycemia.

Last reviewed on RxList: 4/9/2008
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

Single 10 mg doses of SYMLIN (pramlintide acetate injection) (83 times the maximum dose of 120 mcg) were administered to three healthy volunteers. Severe nausea was reported in all three individuals and was associated with vomiting, diarrhea, vasodilatation, and dizziness. No hypoglycemia was reported. SYMLIN (pramlintide acetate injection) has a short half-life and in the case of overdose, supportive measures are indicated.

CONTRAINDICATIONS

SYMLIN (pramlintide acetate injection) is contraindicated in patients with any of the following:

Last reviewed on RxList: 4/9/2008
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Amylin Physiology

Amylin is co-located with insulin in secretory granules and co-secreted with insulin by pancreatic beta cells in response to food intake. Amylin and insulin show similar fasting and postprandial patterns in healthy individuals (Figure 1).

Figure 1: Secretion Profile of Amylin and Insulin in Healthy Adults

Secretion Profile of Amylin and Insulin in Healthy Adults - illustration

Amylin affects the rate of postprandial glucose appearance through a variety of mechanisms. Amylin slows gastric emptying (i.e., the rate at which food is released from the stomach to the small intestine) without altering the overall absorption of nutrients. In addition, amylin suppresses glucagon secretion (not normalized by insulin alone), which leads to suppression of endogenous glucose output from the liver. Amylin also regulates food intake due to centrally-mediated modulation of appetite.

In patients with insulin-using type 2 or type 1 diabetes, the pancreatic beta cells are dysfunctional or damaged, resulting in reduced secretion of both insulin and amylin in response to food.

Mechanism of Action

SYMLIN (pramlintide acetate injection) , by acting as an amylinomimetic agent, has the following effects: 1) modulation of gastric emptying; 2) prevention of the postprandial rise in plasma glucagon; and 3) satiety leading to decreased caloric intake and potential weight loss.

Gastric Emptying. The gastric-emptying rate is an important determinant of the postprandial rise in plasma glucose. SYMLIN (pramlintide acetate injection) slows the rate at which food is released from the stomach to the small intestine following a meal and, thus, it reduces the initial postprandial increase in plasma glucose. This effect lasts for approximately 3 hours following SYMLIN (pramlintide acetate injection) administration. SYMLIN (pramlintide acetate injection) does not alter the net absorption of ingested carbohydrate or other nutrients.

Postprandial Glucagon Secretion. In patients with diabetes, glucagon concentrations are abnormally elevated during the postprandial period, contributing to hyperglycemia. SYMLIN (pramlintide acetate injection) has been shown to decrease postprandial glucagon concentrations in insulin-using patients with diabetes.

Satiety. SYMLIN (pramlintide acetate injection) administered prior to a meal has been shown to reduce total caloric intake. This effect appears to be independent of the nausea that can accompany SYMLIN (pramlintide acetate injection) treatment.

Pharmacokinetics

Absorption. The absolute bioavailability of a single SC dose of SYMLIN (pramlintide acetate injection) is approximately 30 to 40%. Subcutaneous administration of different doses of SYMLIN (pramlintide acetate injection) into the abdominal area or thigh of healthy subjects resulted in dose-proportionate maximum plasma concentrations (Cmax) and overall exposure (expressed as area under the plasma concentration curve or (AUC)) (Table 1).

Table 1: Mean Pharmacokinetic Parameters Following Administration of Single SC Doses of SYMLIN (pramlintide acetate injection)

SC Dose (mcg) AUC (0-∞) (pmol*min/L) Cmax (pmol/L) Tmax (min) Elimination t½ (min)
30 3750 39 21 55
60 6778 79 20 49
90 8507 102 19 51
120 11970 147 21 48

Injection of SYMLIN (pramlintide acetate injection) into the arm showed higher exposure with greater variability, compared with exposure after injection of SYMLIN (pramlintide acetate injection) into the abdominal area or thigh.

There was no strong correlation between the degree of adiposity as assessed by BMI or skin fold thickness measurements and relative bioavailability. Injections administered with 6.0-mm and 12.7-mm needles yielded similar bioavailability.

Distribution. SYMLIN (pramlintide acetate injection) does not extensively bind to blood cells or albumin (approximately 40% of the drug is unbound in plasma), and thus SYMLIN (pramlintide acetate injection) 's pharmacokinetics should be insensitive to changes in binding sites.

Metabolism and Elimination. In healthy subjects, the half-life of SYMLIN (pramlintide acetate injection) is approximately 48 minutes. SYMLIN (pramlintide acetate injection) is metabolized primarily by the kidneys. Des-lys1 pramlintide (2-37 pramlintide), the primary metabolite, has a similar half-life and is biologically active both in vitro and in vivo in rats. AUC values are relatively constant with repeat dosing, indicating no bioaccumulation.

Special Populations.

Renal Insufficiency: Patients with moderate or severe renal impairment (ClCr >20 to ≤ 50 mL/min) did not show increased SYMLIN (pramlintide acetate injection) exposure or reduced SYMLIN (pramlintide acetate injection) clearance, compared to subjects with normal renal function. No studies have been done in dialysis patients.

Hepatic Insufficiency: Pharmacokinetic studies have not been conducted in patients with hepatic insufficiency. However, based on the large degree of renal metabolism (see Metabolism and Elimination), hepatic dysfunction is not expected to affect blood concentrations of SYMLIN (pramlintide acetate injection) .

Geriatric: Pharmacokinetic studies have not been conducted in the geriatric population. SYMLIN (pramlintide acetate injection) should only be used in patients known to fully understand and adhere to proper insulin adjustments and glucose monitoring. No consistent age-related differences in the activity of SYMLIN (pramlintide acetate injection) have been observed in the geriatric population (n=539 for patients 65 years of age or older in the clinical trials).

Pediatric: SYMLIN (pramlintide acetate injection) has not been evaluated in the pediatric population.

Gender: No study has been conducted to evaluate possible gender effects on SYMLIN (pramlintide acetate injection) pharmacokinetics. However, no consistent gender-related differences in the activity of SYMLIN (pramlintide acetate injection) have been observed in the clinical trials (n=2799 for male and n=2085 for female).

Race/Ethnicity: No study has been conducted to evaluate the effect of ethnicity on SYMLIN (pramlintide acetate injection) pharmacokinetics. However, no consistent differences in the activity of SYMLIN (pramlintide acetate injection) have been observed among patients of differing race/ethnicity in the clinical trials (n=4257 for white, n=229 for black, n=337 for Hispanic, and n=61 for other ethnic origins).

Drug Interactions: The effect of SYMLIN (pramlintide acetate injection) (120 mcg) on acetaminophen (1000 mg) pharmacokinetics as a marker of gastric-emptying was evaluated in patients with type 2 diabetes (n=24). SYMLIN (pramlintide acetate injection) did not significantly alter the AUC of acetaminophen. However, SYMLIN (pramlintide acetate injection) decreased acetaminophen Cmax (about 29% with simultaneous co-administration) and increased the time to maximum plasma concentration or tmax (ranging from 48 to 72 minutes) dependent on the time of acetaminophen administration relative to SYMLIN (pramlintide acetate injection) injection. SYMLIN (pramlintide acetate injection) did not significantly affect acetaminophen tmax when acetaminophen was administered 1 to 2 hours before SYMLIN (pramlintide acetate injection) injection. However, the tmax of acetaminophen was significantly increased when acetaminophen was administered simultaneously with or up to 2 hours following SYMLIN injection (see PRECAUTIONS: DRUG INTERACTIONS).

Pharmacodynamics

In clinical studies in patients with insulin-using type 2 and type 1 diabetes, SYMLIN (pramlintide acetate injection) administration resulted in a reduction in mean postprandial glucose concentrations, reduced glucose fluctuations, and reduced food intake. SYMLIN (pramlintide acetate injection) doses differ for insulin-using type 2 and type 1 patients (see DOSAGE AND ADMINISTRATION).

Reduction in Postprandial Glucose Concentrations. SYMLIN (pramlintide acetate injection) administered subcutaneously immediately prior to a meal reduced plasma glucose concentrations following the meal when used with regular insulin or rapid-acting insulin analogs (Figure 2). This reduction in postprandial glucose decreased the amount of short-acting insulin required and limited glucose fluctuations based upon 24-hour glucose monitoring. When rapid-acting analog insulins were used, plasma glucose concentrations tended to rise during the interval between 150 minutes following SYMLIN injection and the next meal (see DOSAGE AND ADMINISTRATION).

Figure 2: Postprandial Plasma Glucose Profiles in Patients With Type 2 and Type 1 Diabetes Receiving SYMLIN (pramlintide acetate injection) and/or Insulin

Postprandial Plasma Glucose Profiles in Patients With Type 2 and Type 1 Diabetes Receiving SYMLIN and/or Insulin - illustration

Reduced Food Intake. A single, subcutaneous dose of SYMLIN (pramlintide acetate injection) 120 mcg (type 2) or 30 mcg (type 1) administered 1 hour prior to an unlimited buffet meal was associated with reductions in total caloric intake (placebo-subtracted mean changes of ~23% and 21%, respectively), which occurred without decreases in meal duration.

Clinical Studies

A total of 5325 patients and healthy volunteers received SYMLIN (pramlintide acetate injection) in clinical studies. This includes 1688 with type 2 diabetes and 2375 with type 1 diabetes in short- and long-term controlled clinical trials, long-term uncontrolled clinical trials, and an open-label study in the clinical practice setting.

Clinical Studies in Type 2 Diabetes

The efficacy of a range of SYMLIN (pramlintide acetate injection) doses was evaluated in several placebo-controlled and open-label clinical trials in insulin-using patients with type 2 diabetes. Based on results obtained in these studies, the recommended dose of SYMLIN (pramlintide acetate injection) for patients with insulin-using type 2 diabetes is 120 mcg administered immediately prior to major meals.

Two, long-term (26 to 52 week), randomized, double-blind, placebo-controlled studies of SYMLIN (pramlintide acetate injection) were conducted in patients with type 2 diabetes using fixed dose insulin to isolate the SYMLIN (pramlintide acetate injection) effect. Demographic and baseline characteristics for the 871 SYMLIN (pramlintide acetate injection) -treated patients are as follows: mean baseline HbA1c ranged from 9.0 to 9.4%, mean age was 56.4 to 59.1 years, mean duration of diabetes ranged from 11.5 to 14.4 years, and mean BMI ranged from 30.1 to 34.4 kg/m2. In both of these studies, SYMLIN (pramlintide acetate injection) or placebo was added to the participants' existing diabetes therapies, which included insulin with or without a sulfonylurea agent and/or metformin.

Table 2 summarizes the composite results across both studies for patients assigned to the 120-mcg dose after 6 months of treatment.

Table 2: Mean (SE) Change in HbA1c, Weight, and Insulin at 6 Months in the Double-Blind, Placebo-Controlled Studies in Patients With Insulin-using Type 2 Diabetes

Variable Placebo SYMLIN
(120 mcg)
Baseline HbA1c (%) 9.3 (0.08) 9.1 (0.06)
Change in HbA1c at 6 Months Relative to Baseline (%) -0.17 (0.07) -0.57 (0.06)*
Placebo-Subtracted HbA1c Change at 6 Months (%) NA -0.40 (0.09)*
Baseline Weight (kg) 91.3 (1.2) 92.5 (1.2)
Change in Weight at 6 Months Relative to Baseline (kg) +0.2 (0.2) -1.5 (0.2)*
Placebo-Subtracted Weight Change at 6 Months (kg) NA -1.7 (0.3)*
Percent Change in Insulin Doses at 6 Months: Rapid/Short-Acting +6.5 (2.7) -3.0 (1.6)*
Percent Change in Insulin Doses at 6 Months: Long-Acting +5.2 (1.4) -0.2 (1.3)*
* Statistically significant reduction compared with placebo (p-value < 0.05).

In a cohort of 145 patients who completed two years of SYMLIN (pramlintide acetate injection) treatment the baseline subtracted HbA1c and weight reductions were: -0.40% and -0.36 kg, respectively.

Open-Label Study in the Clinical Practice Setting. An open-label study of SYMLIN (pramlintide acetate injection) was conducted at the recommended dose of 120 mcg in 166 patients with insulin-using type 2 diabetes who were unable to achieve glycemic targets using insulin alone. A flexible-dose insulin regimen was employed in these patients (see DOSAGE AND ADMINISTRATION). In this study, patients adjusted their insulin regimen based on pre-and post-meal glucose monitoring. At baseline, mean HbA1c was 8.3%, mean age was 54.4 years, mean duration of diabetes was 13.3 years, and mean BMI was 38.6 kg/m2. SYMLIN (pramlintide acetate injection) was administered with major meals. SYMLIN (pramlintide acetate injection) plus insulin treatment for 6 months resulted in a baseline-subtracted mean HbA1c reduction of -0.56 ± 0.15 % and a baseline-subtracted mean weight reduction of -2.76 ± 0.34 kg. These changes were accomplished with reductions in doses of total, short-acting, and long-acting insulin (-6.4 ± 2.66, -10.3 ± 4.84, and -4.20 ± 2.42 %, respectively).

Clinical Studies in Type 1 Diabetes

The efficacy of a range of SYMLIN (pramlintide acetate injection) doses was evaluated in several placebo-controlled and open-label clinical trials conducted in patients with type 1 diabetes. Based on results obtained in these studies, the recommended dose of SYMLIN (pramlintide acetate injection) for patients with type 1 diabetes is 30 mcg or 60 mcg administered immediately prior to major meals.

Three, long-term (26 to 52 week), randomized, double-blind, placebo-controlled studies of SYMLIN (pramlintide acetate injection) were conducted in patients with type 1 diabetes (N=1717). Two of these studies allowed only minimal insulin adjustments in order to isolate the SYMLIN (pramlintide acetate injection) effect; in the third study, insulin adjustments were made according to standard medical practice. Demographic and baseline characteristics for the 1179 SYMLIN (pramlintide acetate injection) -treated patients were as follows: mean baseline HbA1c range was 8.7 to 9.0%, mean age range was 37.3 to 41.9 years, mean duration of diabetes range was 15.5 to 19.2 years, and mean BMI range was 25.0 to 26.8 kg/m2. SYMLIN (pramlintide acetate injection) or placebo was added to existing insulin therapies.

Table 3 summarizes the composite results across these studies for patients assigned to the 30 or 60 mcg dose after 6 months of treatment.

Table 3: Mean (SE) Change in HbA1c, Weight, and Insulin at 6 Months in the Double-Blind, Placebo-Controlled Studies in Patients With Type 1 Diabetes

Variable Placebo SYMLIN
(30 or 60 mcg)
Baseline HbA1c (%) 9.0 (0.06) 8.9 (0.04)
Change in HbA1c at 6 Months Relative to Baseline (%) -0.10 (0.05) -0.43 (0.04)*
Placebo-Subtracted HbA1c Change at 6 Months (%) NA -0.33 (0.06)*
Baseline Weight (kg) 75.1 (0.6) 76.1 (0.5)
Change in Weight at 6 Months Relative to Baseline (kg) +0.6 (0.1) -1.1 (0.1)*
Placebo-Subtracted Weight Change at 6 Months (kg) NA -1.7 (0.1)*
Percent Change in Insulin Doses at 6 Months: Rapid/Short-Acting +1.7 (3.3) -3.6 (2.9)
Percent Change in Insulin Doses at 6 Months: Long-Acting +2.5 (1.9) +1.9 (1.3)
* Statistically significant reduction compared with placebo (p-value < 0.05).

In a cohort of 73 patients who completed two years of SYMLIN (pramlintide acetate injection) treatment the baseline subtracted HbA1c and weight changes were: -0.35% and 0.60 kg, respectively.

SYMLIN (pramlintide acetate injection) Dose-Titration Trial. A dose-titration study of SYMLIN (pramlintide acetate injection) was conducted in patients with type 1 diabetes. Patients with relatively good baseline glycemic control (mean HbA1c = 8.1%) were randomized to receive either insulin plus placebo or insulin plus SYMLIN (pramlintide acetate injection) . Other baseline and demographics characteristics were: mean age of 41 years, mean duration of diabetes of 20 years, mean BMI of 28 kg/m2. SYMLIN (pramlintide acetate injection) was initiated at a dose of 15 mcg and titrated upward at weekly intervals by 15-mcg increments to doses of 30 mcg or 60 mcg, based on whether patients experienced nausea. Once a tolerated dose of either 30 mcg or 60 mcg was reached, the SYMLIN (pramlintide acetate injection) dose was maintained for the remainder of the study (SYMLIN (pramlintide acetate injection) was administered before major meals). During SYMLIN (pramlintide acetate injection) titration, the insulin dose (mostly the short/rapid acting insulin) was reduced by 30-50% in order to reduce the occurrence of hypoglycemia. Once a tolerated SYMLIN (pramlintide acetate injection) dose was reached, insulin dose adjustments were made according to standard clinical practice, based on pre- and post-meal blood glucose monitoring. By 6 months of treatment, patients treated with SYMLIN (pramlintide acetate injection) and insulin and patients treated with insulin and placebo had equivalent reductions in mean HbA1c (-0.47 ± 0.07 % vs. -0.49 ± 0.07 %, respectively); patients on SYMLIN (pramlintide acetate injection) lost weight (-1.33 ± 0.31 kg relative to baseline and -2.6 kg relative to placebo plus insulin-treated patients). SYMLIN (pramlintide acetate injection) -treated patients used less total insulin (-11.7% relative to baseline) and less short/rapid-acting insulin (-22.8%) relative to baseline.

Open-Label Study in the Clinical Practice Setting. An open-label study of SYMLIN (pramlintide acetate injection) was conducted in patients with type 1 diabetes who were unable to achieve glycemic targets using insulin alone. A flexible-dose insulin regimen was employed in these patients after SYMLIN titration was completed (see DOSAGE AND ADMINISTRATION). In this study, patients adjusted their insulin regimen based on pre-and post-meal glucose monitoring. At baseline, mean HbA1c was 8.0%, mean age was 42.7 years, mean duration of diabetes was 21.2 years, and mean BMI was 28.6 kg/m2. SYMLIN (pramlintide acetate injection) daily dosage was 30 mcg or 60 mcg with major meals.

SYMLIN (pramlintide acetate injection) plus insulin reduced HbA1c and body weight from baseline at 6 months by a mean of 0.18% and 3.0 kg, respectively. These changes in glycemic control and body weight were achieved with reductions in doses of total, short-acting, and long-acting insulin (-12.0 ± 1.36, -21.7 ± 2.81, and -0.4 ± 1.59 %, respectively).

Last reviewed on RxList: 4/9/2008
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

Medication Guide

SYMLIN®
(SiM-lin)
(pramlintide acetate) injection

Read the Medication Guide and the "Patient Instructions for Use" that come with your SYMLIN (pramlintide acetate injection) product before you start using it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment.

What is the most important information I should know about SYMLIN (pramlintide acetate injection) ?

  • SYMLIN (pramlintide acetate injection) is used with insulin to lower blood sugar, especially high blood sugar that happens after meals.
  • SYMLIN (pramlintide acetate injection) is given at mealtimes. The use of SYMLIN (pramlintide acetate injection) does not replace your daily insulin but may lower the amount of insulin you need, especially before meals.
  • Even when SYMLIN (pramlintide acetate injection) is carefully added to your mealtime insulin therapy, your blood sugar may drop too low, especially if you have type 1 diabetes. If this low blood sugar (severe hypoglycemia) happens, it is seen within 3 hours after a SYMLIN (pramlintide acetate injection) injection. Severe low blood sugar makes it hard to think clearly, drive a car, use heavy machinery or do other risky activities where you could hurt yourself or others.
  • SYMLIN (pramlintide acetate injection) should only be used by people with type 2 and type 1 diabetes who:
    • already use their insulin as prescribed, but still need better blood sugar control.
    • will follow their doctor's instructions exactly.
    • will follow up with their doctor often.
    • will test their blood sugar levels before and after every meal, and at bedtime.
    • understand how to adjust SYMLIN (pramlintide acetate injection) and insulin doses.

What is SYMLIN (pramlintide acetate injection) ?

SYMLIN (pramlintide acetate injection) is an injectable medicine for adults with type 2 and type 1 diabetes to control blood sugar. SYMLIN (pramlintide acetate injection) slows down the movement of food through your stomach. This affects how fast sugar enters your blood after eating. SYMLIN (pramlintide acetate injection) is always used with insulin to help lower blood sugar during the 3 hours after meals.

Who should not use SYMLIN (pramlintide acetate injection) ?

Do not use SYMLIN (pramlintide acetate injection) if you:

  • cannot tell when your blood sugar is low (hypoglycemia unawareness).
  • have a stomach problem called gastroparesis. This is when your stomach does not empty as fast as it should.
  • are allergic to SYMLIN (pramlintide acetate injection) or any ingredients in SYMLIN (pramlintide acetate injection) . See the end of this Medication Guide for a complete list of ingredients.

SYMLIN (pramlintide acetate injection) has not been studied in children.

What should I tell my doctor before starting SYMLIN (pramlintide acetate injection) ?

Tell your doctor about all of your medical conditions including if you:

  • are pregnant or planning to become pregnant. It is not known if SYMLIN (pramlintide acetate injection) can harm your unborn baby. You and your doctor will decide how to best control your blood sugar levels during pregnancy.
  • are breastfeeding. It is not known if SYMLIN (pramlintide acetate injection) passes into your milk and if it can harm your baby. You and your doctor will decide the best way to feed your baby if you are using SYMLIN (pramlintide acetate injection) .

Keep a list of all the medicines you take. Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. SYMLIN (pramlintide acetate injection) can slow down how other medicines pass through your stomach and may affect how much of them get into your body. You may have to change the times you take certain medicines.

How should I use SYMLIN (pramlintide acetate injection) ?

  • You must use SYMLIN (pramlintide acetate injection) exactly as prescribed. The amount of SYMLIN (pramlintide acetate injection) you use will depend on whether you have type 2 or type 1 diabetes. You and your doctor will decide if you can use SYMLIN (pramlintide acetate injection) .
  • It is important for you to carefully read, understand and follow the "Patient Instructions for Use" that comes along with this Medication Guide and your SYMLIN (pramlintide acetate injection) .
  • SYMLIN (pramlintide acetate injection) is available in vials and two Symlin (pramlintide acetate injection) Pen™ pen-injectors. Your doctor will prescribe the type of SYMLIN (pramlintide acetate injection) that is right for you.
    • If you have been using the SYMLIN (pramlintide acetate injection) vial with an insulin syringe and you are changing to the Symlin (pramlintide acetate injection) Pen™ pen-injector: Your doctor will prescribe the Symlin (pramlintide acetate injection) Pen™ pen- injector that is right for you, tell you how much SYMLIN (pramlintide acetate injection) to inject and when to inject it.
    • It is important that you understand how to inject the right SYMLIN (pramlintide acetate injection) dose. Read the "Patient Instructions for Use" carefully BEFORE giving your first dose with the Symlin (pramlintide acetate injection) Pen™ pen-injector. The SYMLIN (pramlintide acetate injection) in the pen-injector is a different strength than the SYMLIN (pramlintide acetate injection) in the vial.
  • The way you inject SYMLIN (pramlintide acetate injection) is similar to the way you inject insulin. Inject SYMLIN (pramlintide acetate injection) under the skin (subcutaneously) of your stomach area (abdomen) or upper leg (thigh). Inject SYMLIN (pramlintide acetate injection) at a site that is more than 2 inches away from your insulin injection. Do not inject SYMLIN (pramlintide acetate injection) and insulin in the same site.
  • To help reduce the chances of getting a reaction at the injection site, allow SYMLIN (pramlintide acetate injection) to come to room temperature before injecting.
  • Use a new needle for each SYMLIN (pramlintide acetate injection) injection.
  • Never mix SYMLIN (pramlintide acetate injection) and insulin. Insulin can affect SYMLIN (pramlintide acetate injection) when the two are mixed together.
  • Do not use SYMLIN (pramlintide acetate injection) if the liquid looks cloudy.
  • If you take more than your prescribed dose of SYMLIN (pramlintide acetate injection) , you may get nauseous or vomit, and you may not be able to eat the amount of food you usually eat. If you take more SYMLIN (pramlintide acetate injection) than your prescribed dose, pay careful attention to the amount of insulin you use because you may be at more risk for low blood sugar. Contact your doctor for guidance.
  • If you miss or forget a dose of SYMLIN (pramlintide acetate injection) , wait until the next meal and take your usual dose of SYMLIN (pramlintide acetate injection) at that meal. Do not take more than your usual dose of SYMLIN (pramlintide acetate injection) .

Using SYMLIN (pramlintide acetate injection) and insulin with Type 2 Diabetes

  1. Start SYMLIN (pramlintide acetate injection) at 60 mcg injected under your skin, just before major meals. A major meal must have at least 250 calories or 30 grams of carbohydrate.
  2. Reduce your rapid-acting or short-acting insulin, including fixed-mix insulin such as 70/30, used before meals by 50 percent. This means half of the dose you usually use.
  3. You must check your blood sugar before and after every meal and at bedtime.
  4. Increase your dose of SYMLIN (pramlintide acetate injection) to 120 mcg on your doctor's instructions if you have not had any nausea for 3 days or more.
  5. Tell your doctor right away if you have nausea with the 120 mcg dose. Your doctor will tell you how to adjust your dose of SYMLIN (pramlintide acetate injection) .
  6. Your doctor may make changes to your insulin doses to better control your blood sugar once you are using the 120 mcg dose of SYMLIN (pramlintide acetate injection) . All insulin changes should be directed by your doctor.

Using SYMLIN (pramlintide acetate injection) and insulin with Type 1 Diabetes

  1.  Start SYMLIN (pramlintide acetate injection) at 15 mcg injected under your skin, just before major meals. A major meal must have at least 250 calories or 30 grams of carbohydrate.
  2. When starting SYMLIN (pramlintide acetate injection) , reduce your rapid-acting or short-acting insulin, including fixed-mix insulin such as 70/30, used before meals by 50 percent. This means half of the dose you usually use. All insulin changes should be directed by your doctor.
  3. You must check your blood sugar before and after every meal and at bedtime.
  4. Increase your dose of SYMLIN (pramlintide acetate injection) to 30 mcg on your doctor's instructions if you have not had any nausea for 3 days or more. If you have nausea with SYMLIN (pramlintide acetate injection) at 30 mcg, call your doctor right away. Your doctor may decide that you should stop SYMLIN (pramlintide acetate injection) .
  5. Increase your dose of SYMLIN (pramlintide acetate injection) to 45 mcg on your doctor's instructions if you have not had any nausea for 3 days or more while using the 30 mcg dose.
  6. Increase your dose of SYMLIN (pramlintide acetate injection) to 60 mcg on your doctor's instructions if you have not had any nausea for 3 days or more while using the 45 mcg dose.
  7. Call your doctor right away if you are bothered with nausea on the 45 mcg or 60 mcg dose. Your doctor may decide that you should reduce SYMLIN (pramlintide acetate injection) to the 30 mcg dose.
  8. Your doctor may make changes to your insulin doses to better control your blood sugar once you are on a dose of SYMLIN (pramlintide acetate injection) that is right for you. All insulin changes should be directed by your doctor.

Staying on SYMLIN (pramlintide acetate injection)

  • Once you reach your recommended dose of SYMLIN (pramlintide acetate injection) , talk to your doctor about changing your insulin doses to better control your blood sugar. You may have to increase your long-acting insulin to prevent high blood sugar (hyperglycemia) between meals. Insulin changes should always be directed by your doctor based on blood sugar testing.
  • Call your doctor if nausea or low blood sugar continues while on your recommended dose of SYMLIN (pramlintide acetate injection) . Low blood sugar that happens often is a warning sign of possible severe low blood sugar, especially if you have type 1 diabetes.
  • If you stop taking SYMLIN (pramlintide acetate injection) for any reason, such as surgery or illness, talk to your doctor about how to re-start SYMLIN (pramlintide acetate injection) .

When should I not use SYMLIN (pramlintide acetate injection) ?

Do not use SYMLIN (pramlintide acetate injection) if:

  • your blood sugar is too low.
  • you do not plan to eat. Do not inject SYMLIN (pramlintide acetate injection) if you skip a meal.
  • you plan to eat a meal with less than 250 calories or 30 grams of carbohydrate.
  • you are sick and can't eat your usual meal.
  • you are having surgery or a medical test where you cannot eat.
  • you are pregnant or breastfeeding and have not talked to your doctor. Talk to your doctor if you have any of these conditions.

What should I avoid while taking SYMLIN (pramlintide acetate injection) ?

  • Do not drive or operate dangerous machinery until you know how SYMLIN (pramlintide acetate injection) affects your blood sugar. Low blood sugar makes it hard to think clearly, drive a car, use heavy machinery or do other risky activities where you could hurt yourself or others. Discuss with your doctor what activities you should avoid.
  • Alcohol may increase the risk of low blood sugar.
  • Your doctor will tell you which medicines you can take while using SYMLIN (pramlintide acetate injection) . Do not take other medicines that slow stomach emptying.

What are the possible side effects of SYMLIN (pramlintide acetate injection) ?

Low blood sugar (hypoglycemia)

  • SYMLIN (pramlintide acetate injection) is used with insulin to lower your blood sugar, but your blood sugar may drop too low, especially if you have type 1 diabetes. See "What is the most important information I should know about SYMLIN (pramlintide acetate injection) ?"
  • When starting SYMLIN (pramlintide acetate injection) , reduce your doses of insulin before meals as recommended by your doctor to reduce the chance of low blood sugar. You and your doctor should talk about a plan to treat low blood sugar. You should have fast-acting sugar (such as hard candy, glucose tablets, juice) or glucagon with you at all times. Call your doctor if you have low blood sugar more often than normal or severe low blood sugar.

Your chance for low blood sugar is higher if you:

  • do not reduce your insulin dose before meals at the beginning of SYMLIN (pramlintide acetate injection) treatment, as directed by your doctor.
  • use more SYMLIN (pramlintide acetate injection) or insulin than prescribed by your doctor.
  • change your insulin dose without checking your blood sugar.
  • eat less food than your usual meal.
  • are sick and cannot eat.
  • are more active than usual.
  • have a low blood sugar level before eating.
  • drink alcohol.

Always have fast-acting sugar (such as hard candy, glucose tablets, juice) or glucagon available to treat low blood sugar.

Nausea: Nausea is the most common side effect with SYMLIN (pramlintide acetate injection) . Mild nausea is more likely during the first weeks after starting SYMLIN (pramlintide acetate injection) and usually does not last long. It is very important to start SYMLIN (pramlintide acetate injection) at a low dose and increase it as directed by your doctor. See "How should I use SYMLIN (pramlintide acetate injection) ?" If nausea continues or bothers you, call your doctor right away.

Other Side Effects: SYMLIN (pramlintide acetate injection) also may cause the following side effects: decreased appetite, vomiting, stomach pain, tiredness, dizziness, or indigestion.

SYMLIN (pramlintide acetate injection) also can cause reactions at the injection site including redness, minor bruising, or pain. See the detailed "Patient Instructions for Use." Follow the directions under "How should I use SYMLIN (pramlintide acetate injection) ?" to reduce the chance of an injection site reaction.

Tell your doctor if you have any side effects that bother you or that do not go away.

These are not all the side effects with SYMLIN (pramlintide acetate injection) . Ask your doctor or pharmacist for more information.

How should I store SYMLIN (pramlintide acetate injection) ?

  • Store SYMLIN (pramlintide acetate injection) that has not been opened in the refrigerator, between 36°F to 46°F (2°C to 8°C), until you are ready to use it. Protect SYMLIN (pramlintide acetate injection) from light.
  • After a vial or pen-injector has been used for the first time, it can be refrigerated or kept at a temperature up to 86?F (30?C) for 30 days. Do not leave above 86?F (30?C). Any vial or pen-injector in use should be thrown away after 30 days, even if it still has medicine in it.
  • Unused SYMLIN (pramlintide acetate injection) (opened or unopened) should not be used after the expiration (EXP) date printed on the carton and the label.
  • Do not freeze SYMLIN (pramlintide acetate injection) . Do not use SYMLIN (pramlintide acetate injection) if it has been frozen. Keep SYMLIN (pramlintide acetate injection) and all medicines out of the reach of children.

General information about the safe and effective use of SYMLIN (pramlintide acetate injection)

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use SYMLIN (pramlintide acetate injection) for a condition for which it was not prescribed. Do not give SYMLIN (pramlintide acetate injection) to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about SYMLIN (pramlintide acetate injection) . Also see the "Patient Instructions for Use" on using the Symlin (pramlintide acetate injection) Pen™ pen-injector or vial. You can ask your doctor for more about SYMLIN (pramlintide acetate injection) , including information that is written for doctors.

More information on SYMLIN (pramlintide acetate injection) can be found at http://www.SYMLIN (pramlintide acetate injection) .com. SYMLIN (pramlintide acetate injection) Customer Service is available 24 hours a day at 1-800-349-8919.

What are the ingredients in SYMLIN?

Active ingredient: pramlintide acetate

Inactive ingredients: metacresol, D-mannitol, acetic acid, and sodium acetate.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Patients Instructions for Use
Read the Medication Guide first.

These instructions do not take the place of talking with your doctor about your diabetes treatment. Ask your doctor about your dose and preferred injection technique. If you have questions or concerns about SYMLIN (pramlintide acetate injection) , please visit www.SYMLIN (pramlintide acetate injection) .com or call Amylin Customer Support toll free at 1-800-349-8919

Prepare and inject your dose

  1. Inspect your SYMLIN (pramlintide acetate injection) vial. The liquid in the vial should be clear and colorless.
  2. Check the expiration date (EXP) on the label to be sure your SYMLIN (pramlintide acetate injection) is not expired (see Figure A).
  3. Clean the top of the SYMLIN (pramlintide acetate injection) vial with an alcohol swab.
  4. Prepare and inject your dose - illustration 1

  5. Pull the plunger of the syringe to the line that matches your SYMLIN (pramlintide acetate injection) dose (see SYMLIN (pramlintide acetate injection) Dosing Chart and Figure B). The amount of air in the syringe should equal the amount of SYMLIN (pramlintide acetate injection) you plan to take.
  6. Prepare and inject your dose - illustration 2

  7. Push the needle through the center of the rubber top of the SYMLIN (pramlintide acetate injection) vial (see Figure C).
  8. Push the plunger to inject the air into the vial.
  9. Prepare and inject your dose - illustration 3

  10. Turn the vial and syringe upside down.
  11. Slowly pull the plunger down to draw the SYMLIN (pramlintide acetate injection) into the syringe until you have your correct dose (see Figure D).
  12. BEFORE removing the syringe from the vial, look for air bubbles inside the syringe. If you see bubbles, push the SYMLIN (pramlintide acetate injection) back into the vial. Then slowly pull the plunger down to draw the SYMLIN (pramlintide acetate injection) into the syringe until you have your correct dose.
  13. Prepare and inject your dose - illustration 4

  14. Check to be sure your dose is correct, then remove the syringe from the vial.
  15. Give your injection as directed by your healthcare provider.
  16. Dispose of the used syringe as directed by your healthcare provider.

Care and Storage

  • Store SYMLIN (pramlintide acetate injection) that has not been opened in the refrigerator, between 36°F to 46°F (2°C to 8°C), until you are ready to use it. Protect SYMLIN (pramlintide acetate injection) from light.
  • After a vial has been used for the first time, it can be refrigerated or kept at a temperature up to 86°F (30°C) for 30 days. Do not leave above 86°F (30°C).
  • Any vial in use should be thrown away after 30 days, even if it still has medicine in it.
  • Unused SYMLIN (pramlintide acetate injection) (opened or unopened) should not be used after the expiration (EXP) date printed on the carton and the label.
  • Do not freeze SYMLIN (pramlintide acetate injection) . Do not use SYMLIN (pramlintide acetate injection) if it has been frozen.
  • Keep SYMLIN (pramlintide acetate injection) and all medicines out of the reach of children

About SYMLIN (pramlintide acetate injection)

  • The way you inject SYMLIN (pramlintide acetate injection) is similar to the way you inject insulin. Inject SYMLIN (pramlintide acetate injection) under the skin (subcutaneously) of your stomach area (abdomen) or upper leg (thigh). Inject SYMLIN (pramlintide acetate injection) at a site that is more than 2 inches away from your insulin injection. To help reduce the chances of getting a reaction at the injection site, allow SYMLIN (pramlintide acetate injection) to come to room temperature before injecting. Also, use a new needle for each SYMLIN (pramlintide acetate injection) injection.
  • If you take more than your prescribed dose of SYMLIN (pramlintide acetate injection) , you may get nauseous or vomit, and you may not be able to eat the amount of food you usually eat. Pay careful attention to the amount of insulin you use at this time as you may be at more risk for low blood sugar. Contact your doctor for guidance.
  • If you miss or forget a dose of SYMLIN (pramlintide acetate injection) , wait until the next meal and take your usual dose of SYMLIN (pramlintide acetate injection) at that meal. Do not take more than your usual dose of SYMLIN (pramlintide acetate injection) .
  • Never mix SYMLIN (pramlintide acetate injection) and insulin. Use different syringes for SYMLIN (pramlintide acetate injection) and insulin. Insulin can affect SYMLIN (pramlintide acetate injection) when the two are mixed together.
  • Your prescription may be written in micrograms, and your insulin syringe is labeled in units. Use the chart below to convert micrograms to units.

SYMLIN Dosing Chart
Find Your Dose in Micrograms (meg) Draw Up This Amount in U-100 Insulin Syringe (Units)
15 mcg 2½ units
30 mcg 5 units
45 mcg 7½ units
60 mcg 10 units
120 mcg 20 units

Pen Parts - illustration

Symlin (pramlintide acetate injection) Pen™ 60 Pen-Injector Patient Instructions for Use
Read the Medication Guide first

Attach Pen Needle - illustration

Important Notes

  • Ask your doctor about your dose, injection technique, and needle size.
  • Pen may look empty because SYMLIN (pramlintide acetate injection) is a clear, colorless liquid.
  • Small bubbles will not harm you or affect your dose.
  • DO NOT TRANSFER YOUR SYMLIN (pramlintide acetate injection) FROM THE PEN TO A SYRINGE. This could result in a higher dose than intended, because the SYMLIN (pramlintide acetate injection) in the Pen is a different strength than the SYMLIN (pramlintide acetate injection) in the vial.

New Pen Setup - illustration

Routine use - illustration

Symlin (pramlintide acetate injection) Pen™ pen-injector (Pen)

Read these instructions carefully before using your Pen. Failure to follow these instructions may cause an incorrect dose, a broken Pen, or an infection.

  • Check Pen label before each use to make sure you have the 15•30•45•60 mcg Pen.
  • Check the expiration date (EXP) on the Pen label (see Pen Parts), and make sure the Pen is not expired.
  • If you drop your Pen, go to New Pen Setup to confirm Pen works.
  • If any part of your Pen appears broken or damaged, do not use.
  • This Pen is not recommended for use by blind or visually impaired persons without the assistance of a person trained in the proper use of this Pen.
  • If SYMLIN (pramlintide acetate injection) in the Cartridge (see Pen Parts) is not clear, colorless, and free of particles, do not use Pen.

Needles

  • Use a new needle for each injection. Remove the needle from the Pen after completing each injection. This will help prevent leakage of SYMLIN (pramlintide acetate injection) , keep out air bubbles, reduce needle clogs, and reduce risk of infection.
  • Pen needles are not included with the Pen. Use 29, 30, or 31 gauge disposable needles with the Pen. Ask your healthcare provider which needle gauge and length is best for you.
  • Do not share your Pen or needles with anyone.
  • Be sure the needle is completely attached to the Pen before use (see Attach Pen Needle). Do not push the Knob unless a needle is attached to Pen.
  • Throw away used needles in a puncture-resistant container or as directed by your healthcare provider. Do not throw away the Pen with a needle attached.
  • Follow local or institutional policies regarding needle handling and disposal.

Care and Storage

  • Pen that has never been used:
    -Refrigerate (36°F to 46°F, 2°C to 8°C).
    -Protect from light.
    -Do not freeze. Do not use a Pen that has been frozen.
  • Pen in use:
    -After the Pen is used for the first time (first use), refrigerate or keep at a temperature up to 86°F (30°C) for 30 days. Throw away Pen 30 days after first use, even if it still has SYMLIN (pramlintide acetate injection) in it.
  • Pen should not be used after the expiration (EXP) date printed on the label.
  • Do not store Pen with needle attached, or with Knob pulled out.
  • If needed, wipe only the outside of Pen with a clean, damp cloth (water only).
  • White particles may appear where the needle attaches during normal use. You may remove the particles with an alcohol wipe or alcohol swab.
  • Keep Pen and needles out of the reach of children.

About SYMLIN (pramlintide acetate injection)

  • The way you inject SYMLIN (pramlintide acetate injection) is similar to the way you inject insulin. Inject SYMLIN (pramlintide acetate injection) under the skin (subcutaneously) of your stomach area (abdomen) or upper leg (thigh). Inject SYMLIN (pramlintide acetate injection) at a site that is more than 2 inches away from your insulin injection. To help reduce the chances of getting a reaction at the injection site, allow SYMLIN (pramlintide acetate injection) to come to room temperature before injecting. Also, use a new needle for each SYMLIN (pramlintide acetate injection) injection.
  • If you take more than your prescribed dose of SYMLIN (pramlintide acetate injection) , you may get nauseous or vomit, and you may not be able to eat the amount of food you usually eat. Pay careful attention to the amount of insulin you use at this time as you may be at more risk for low blood sugar. Contact your doctor for guidance.
  • If you miss or forget a dose of SYMLIN (pramlintide acetate injection) , wait until the next meal and take your usual dose of SYMLIN (pramlintide acetate injection) at that meal. Do not take more than your usual dose of SYMLIN (pramlintide acetate injection) .

Questions and Answers (Q&A)

Why does my new Pen look empty?

  • Because SYMLIN (pramlintide acetate injection) is clear and colorless, the Cartridge (see Pen Parts) may look empty, even though there is medicine in it.
  • To be sure there is SYMLIN (pramlintide acetate injection) in the Cartridge, perform Pen setup (see New Pen Setup).

What should I do if I see air bubbles?

  • The Cartridge may contain small air bubbles. Small air bubbles are normal and will not harm you or affect your dose.
  • Perform New Pen Setup before the first dose with each new Pen (see New Pen Setup).
  • To prevent more air bubbles, do NOT store Pen with needle attached.

Why can't I turn the Dial?

  • If the Knob has been pulled out, the Dial will not move and you cannot reset your dose. Push in the Knob to discard the dose and repeat the instructions (see Routine Use).
  • If the Knob is pushed in all the way, and you cannot rotate the Dial, call Amylin Customer Support.

What should I do if I do not see a stream of liquid when I perform the setup?

  • Watch for a stream when you start to push the Knob.
  • The liquid is clear and colorless, so it may be difficult to see.
  • Pull out the Knob all the way - you will hear clicking.
  • Firmly push in the Knob all the way- you will hear clicking.
  • If there is no stream of liquid after 6 attempts, replace the needle and repeat setup.
  • If still no stream, call Amylin Customer Support.

What should I do if I load an incorrect dose?

  • Do not inject an incorrect dose. Point the needle away from you and discard the dose by pushing in the Knob all the way. Dial your correct dose.

How do I make sure I am getting my correct dose of SYMLIN (pramlintide acetate injection) ?

  • Before pulling out Knob, be sure the number in Window matches your prescribed SYMLIN (pramlintide acetate injection) dose (see Figure A).
  • Pull out the Knob all the way - you will hear clicking (see Figure B).
  • Be sure that number on the Dose Check matches your dose in Window.
    You must see line, arrow, and number on Dose Check (see Figure C).
  • Firmly push in the Knob all the way - you will hear clicking.
  • Hold Knob for 10 seconds before removing needle from skin (see Figure E).

Why do I see SYMLIN (pramlintide acetate injection) leaking from my needle after I inject?

  • You may see one or two drops - this is normal.
  • If you see more than 2 drops:
    -You may not have received your full dose.
    -Do not inject another dose.
    -Talk to your healthcare provider.
  • To prevent dripping or leaking, be sure to firmly push and hold Knob with your thumb for 10 seconds before removing needle from skin.

How do I know when my pen is empty?

  • Check Your Dose after pulling out the Knob (see Figure C).
  • The lines on the Cartridge show approximately how much SYMLIN (pramlintide acetate injection) is left in the Pen. When the Plunger is at the thickest line on the Cartridge, your Pen is almost empty (see Figure F).

How to know when the pen is empty - illustration 1

  • If you cannot see the line, arrow, and number that match your prescribed dose, you do not have enough SYMLIN (pramlintide acetate injection) to give your full dose (see Figure H). Throw away this Pen, and use a new Pen to give your dose.

How to know when the pen is empty - illustration 2

The Patient Instructions for Use do not take the place of talking with your doctor about your diabetes treatment. Ask your doctor about your dose and preferred injection technique. If you are having problems using your Pen, please visit www.SYMLIN (pramlintide acetate injection) .com or call Amylin Customer Support toil free at 1-800-349-8919.

Pen parts - illustration

Symlin (pramlintide acetate injection) Pen™ 120 Pen-Injector Patient Instructions for Use
Read the Medication Guide first

Attach pen needle - illustration

Important Notes

  • Ask your doctor about your dose, injection technique, and needle size.
  • Pen may look empty because SYMLIN (pramlintide acetate injection) is a clear, colorless liquid.
  • Small bubbles will not harm you or affect your dose.
  • DO NOT TRANSFER YOUR SYMLIN (pramlintide acetate injection) FROM THE PEN TO A SYRINGE. This could result in a higher dose than intended, because the SYMLIN (pramlintide acetate injection) in the Pen is a different strength than the SYMLIN (pramlintide acetate injection) in the vial.

New pen setup - illustration

routine use - illustration

Symlin (pramlintide acetate injection) Pen™ pen-injector (Pen)

Read these instructions carefully before using your Pen. Failure to follow these instructions may cause an incorrect dose, a broken Pen, or an infection.

  • Check Pen label before each use to make sure you have the 60•120 mcg Pen.
  • Check the expiration date (EXP) on the Pen label (see Pen Parts), and make sure the Pen is not expired.
  • If you drop your Pen, go to New Pen Setup to confirm Pen works.
  • If any part of your Pen appears broken or damaged, do not use.
  • This Pen is not recommended for use by blind or visually impaired persons without the assistance of a person trained in the proper use of this Pen.
  • If SYMLIN (pramlintide acetate injection) in the Cartridge (see Pen Parts) is not clear, colorless, and free of particles, do not use Pen.

Needles

  • Use a new needle for each injection. Remove the needle from the Pen after completing each injection. This will help prevent leakage of SYMLIN (pramlintide acetate injection) , keep out air bubbles, reduce needle clogs, and reduce risk of infection.
  • Pen needles are not included with the Pen. Use 29, 30, or 31 gauge disposable needles with the Pen. Ask your healthcare provider which needle gauge and length is best for you.
  • Do not share your Pen or needles with anyone.
  • Be sure the needle is completely attached to the Pen before use (see Attach Pen Needle). Do not push the Knob unless a needle is attached to Pen.
  • Throw away used needles in a puncture-resistant container or as directed by your healthcare provider. Do not throw away the Pen with a needle attached.
  • Follow local or institutional policies regarding needle handling and disposal.

Care and Storage

  • Pen that has never been used:
    -Refrigerate (36°F to 46°F, 2°C to 8°C).
    -Protect from light.
    -Do not freeze. Do not use a Pen that has been frozen.
  • Pen in use:
    -After the Pen is used for the first time (first use), refrigerate or keep at a temperature up to 86°F (30°C) for 30 days. Throw away Pen 30 days after first use, even if it still has SYMLIN (pramlintide acetate injection) in it.
  • Pen should not be used after the expiration (EXP) date printed on the label.
  • Do not store Pen with needle attached, or with Knob pulled out.
  • If needed, wipe only the outside of Pen with a clean, damp cloth (water only).
  • White particles may appear where the needle attaches during normal use. You may remove the particles with an alcohol wipe or alcohol swab.
  • Keep Pen and needles out of the reach of children.

About SYMLIN (pramlintide acetate injection)

  • The way you inject SYMLIN (pramlintide acetate injection) is similar to the way you inject insulin. Inject SYMLIN (pramlintide acetate injection) under the skin (subcutaneously) of your stomach area (abdomen) or upper leg (thigh). Inject SYMLIN (pramlintide acetate injection) at a site that is more than 2 inches away from your insulin injection. To help reduce the chances of getting a reaction at the injection site, allow SYMLIN (pramlintide acetate injection) to come to room temperature before injecting. Also, use a new needle for each SYMLIN (pramlintide acetate injection) injection.
  • If you take more than your prescribed dose of SYMLIN (pramlintide acetate injection) , you may get nauseous or vomit, and you may not be able to eat the amount of food you usually eat. Pay careful attention to the amount of insulin you use at this time as you may be at more risk for low blood sugar. Contact your doctor for guidance.
  • If you miss or forget a dose of SYMLIN (pramlintide acetate injection) , wait until the next meal and take your usual dose of SYMLIN (pramlintide acetate injection) at that meal. Do not take more than your usual dose of SYMLIN (pramlintide acetate injection) .

Questions and Answers (Q&A)

Why does my new Pen look empty?

  • Because SYMLIN (pramlintide acetate injection) is clear and colorless, the Cartridge (see Pen Parts) may look empty, even though there is medicine in it.
  • To be sure there is SYMLIN (pramlintide acetate injection) in the Cartridge, perform Pen setup (see New Pen Setup).

What should I do if I see air bubbles?

  • The Cartridge may contain small air bubbles. Small air bubbles are normal and will not harm you or affect your dose.
  • Perform New Pen Setup before the first dose with each new Pen (see New Pen Setup).
  • To prevent more air bubbles, do NOT store Pen with needle attached.

Why can't I turn the Dial?

  • If the Knob has been pulled out, the Dial will not move and you cannot reset your dose. Push in the Knob to discard the dose and repeat the instructions (see Routine Use).
  • If the Knob is pushed in all the way, and you cannot rotate the Dial, call Amylin Customer Support.

What should I do if I do not see a stream of liquid when I perform the setup?

  • Watch for a stream when you start to push the Knob.
  • The liquid is clear and colorless, so it may be difficult to see.
  • Pull out the Knob all the way - you will hear clicking.
  • Firmly push in the Knob all the way- you will hear clicking.
  • If there is no stream of liquid after 3 attempts, replace the needle and repeat setup.
  • If still no stream, call Amylin Customer Support.

What should I do if I load an incorrect dose?

  • Do not inject an incorrect dose. Point the needle away from you and discard the dose by pushing in the Knob all the way. Dial your correct dose.

How do I make sure I am getting my correct dose of SYMLIN (pramlintide acetate injection) ?

  • Before pulling out Knob, be sure the number in Window matches your prescribed SYMLIN (pramlintide acetate injection) dose (see Figure A).
  • Pull out the Knob all the way - you will hear clicking (see Figure B).
  • Be sure that number on the Dose Check matches your dose in Window.

You must see line, arrow, and number on Dose Check (see Figure C).

  • Firmly push in the Knob all the way - you will hear clicking.
  • Hold Knob for 10 seconds before removing needle from skin (see Figure E).

Why do I see SYMLIN (pramlintide acetate injection) leaking from my needle after I inject?

  • You may see one or two drops
    - this is normal.
  • If you see more than 2 drops:
    -You may not have received your full dose.
    -Do not inject another dose.
    -Talk to your healthcare provider.
  • To prevent dripping or leaking, be sure to firmly push and hold Knob with your thumb for 10 seconds before removing needle from skin.

How do I know when my pen is empty?

  • Check Your Dose after pulling out the Knob (see Figure C).
  • The lines on the Cartridge show approximately how much SYMLIN (pramlintide acetate injection) is left in the Pen. When the Plunger is at the thickest line on the Cartridge, your Pen is almost empty (see Figure F).

How to know when the pen is empty - illustration 1

  • If you cannot see the line, arrow, and number that match your prescribed dose, you do not have enough SYMLIN (pramlintide acetate injection) to give your full dose (see Figure H). Throw away this Pen, and use a new Pen to give your dose.

How to know when the pen is empty - illustration 2

The Patient Instructions for Use do not take the place of talking with your doctor about your diabetes treatment. Ask your doctor about your dose and preferred injection technique. If you are having problems using your Pen, please visit www.SYMLIN (pramlintide acetate injection) .com or call Amylin Customer Support toll free at 1 -800-349-8919.

Last reviewed on RxList: 4/9/2008
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

Medication Guide

SYMLIN®
(SiM-lin)
(pramlintide acetate) injection

Read the Medication Guide and the "Patient Instructions for Use" that come with your SYMLIN (pramlintide acetate injection) product before you start using it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment.

What is the most important information I should know about SYMLIN (pramlintide acetate injection) ?

  • SYMLIN (pramlintide acetate injection) is used with insulin to lower blood sugar, especially high blood sugar that happens after meals.
  • SYMLIN (pramlintide acetate injection) is given at mealtimes. The use of SYMLIN (pramlintide acetate injection) does not replace your daily insulin but may lower the amount of insulin you need, especially before meals.
  • Even when SYMLIN (pramlintide acetate injection) is carefully added to your mealtime insulin therapy, your blood sugar may drop too low, especially if you have type 1 diabetes. If this low blood sugar (severe hypoglycemia) happens, it is seen within 3 hours after a SYMLIN (pramlintide acetate injection) injection. Severe low blood sugar makes it hard to think clearly, drive a car, use heavy machinery or do other risky activities where you could hurt yourself or others.
  • SYMLIN (pramlintide acetate injection) should only be used by people with type 2 and type 1 diabetes who:
    • already use their insulin as prescribed, but still need better blood sugar control.
    • will follow their doctor's instructions exactly.
    • will follow up with their doctor often.
    • will test their blood sugar levels before and after every meal, and at bedtime.
    • understand how to adjust SYMLIN (pramlintide acetate injection) and insulin doses.

What is SYMLIN (pramlintide acetate injection) ?

SYMLIN (pramlintide acetate injection) is an injectable medicine for adults with type 2 and type 1 diabetes to control blood sugar. SYMLIN (pramlintide acetate injection) slows down the movement of food through your stomach. This affects how fast sugar enters your blood after eating. SYMLIN (pramlintide acetate injection) is always used with insulin to help lower blood sugar during the 3 hours after meals.

Who should not use SYMLIN (pramlintide acetate injection) ?

Do not use SYMLIN (pramlintide acetate injection) if you:

  • cannot tell when your blood sugar is low (hypoglycemia unawareness).
  • have a stomach problem called gastroparesis. This is when your stomach does not empty as fast as it should.
  • are allergic to SYMLIN (pramlintide acetate injection) or any ingredients in SYMLIN (pramlintide acetate injection) . See the end of this Medication Guide for a complete list of ingredients.

SYMLIN (pramlintide acetate injection) has not been studied in children.

What should I tell my doctor before starting SYMLIN (pramlintide acetate injection) ?

Tell your doctor about all of your medical conditions including if you:

  • are pregnant or planning to become pregnant. It is not known if SYMLIN (pramlintide acetate injection) can harm your unborn baby. You and your doctor will decide how to best control your blood sugar levels during pregnancy.
  • are breastfeeding. It is not known if SYMLIN (pramlintide acetate injection) passes into your milk and if it can harm your baby. You and your doctor will decide the best way to feed your baby if you are using SYMLIN (pramlintide acetate injection) .

Keep a list of all the medicines you take. Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. SYMLIN (pramlintide acetate injection) can slow down how other medicines pass through your stomach and may affect how much of them get into your body. You may have to change the times you take certain medicines.

How should I use SYMLIN (pramlintide acetate injection) ?

  • You must use SYMLIN (pramlintide acetate injection) exactly as prescribed. The amount of SYMLIN (pramlintide acetate injection) you use will depend on whether you have type 2 or type 1 diabetes. You and your doctor will decide if you can use SYMLIN (pramlintide acetate injection) .
  • It is important for you to carefully read, understand and follow the "Patient Instructions for Use" that comes along with this Medication Guide and your SYMLIN (pramlintide acetate injection) .
  • SYMLIN (pramlintide acetate injection) is available in vials and two Symlin (pramlintide acetate injection) Pen™ pen-injectors. Your doctor will prescribe the type of SYMLIN (pramlintide acetate injection) that is right for you.
    • If you have been using the SYMLIN (pramlintide acetate injection) vial with an insulin syringe and you are changing to the Symlin (pramlintide acetate injection) Pen™ pen-injector: Your doctor will prescribe the Symlin (pramlintide acetate injection) Pen™ pen- injector that is right for you, tell you how much SYMLIN (pramlintide acetate injection) to inject and when to inject it.
    • It is important that you understand how to inject the right SYMLIN (pramlintide acetate injection) dose. Read the "Patient Instructions for Use" carefully BEFORE giving your first dose with the Symlin (pramlintide acetate injection) Pen™ pen-injector. The SYMLIN (pramlintide acetate injection) in the pen-injector is a different strength than the SYMLIN (pramlintide acetate injection) in the vial.
  • The way you inject SYMLIN (pramlintide acetate injection) is similar to the way you inject insulin. Inject SYMLIN (pramlintide acetate injection) under the skin (subcutaneously) of your stomach area (abdomen) or upper leg (thigh). Inject SYMLIN (pramlintide acetate injection) at a site that is more than 2 inches away from your insulin injection. Do not inject SYMLIN (pramlintide acetate injection) and insulin in the same site.
  • To help reduce the chances of getting a reaction at the injection site, allow SYMLIN (pramlintide acetate injection) to come to room temperature before injecting.
  • Use a new needle for each SYMLIN (pramlintide acetate injection) injection.
  • Never mix SYMLIN (pramlintide acetate injection) and insulin. Insulin can affect SYMLIN (pramlintide acetate injection) when the two are mixed together.
  • Do not use SYMLIN (pramlintide acetate injection) if the liquid looks cloudy.
  • If you take more than your prescribed dose of SYMLIN (pramlintide acetate injection) , you may get nauseous or vomit, and you may not be able to eat the amount of food you usually eat. If you take more SYMLIN (pramlintide acetate injection) than your prescribed dose, pay careful attention to the amount of insulin you use because you may be at more risk for low blood sugar. Contact your doctor for guidance.
  • If you miss or forget a dose of SYMLIN (pramlintide acetate injection) , wait until the next meal and take your usual dose of SYMLIN (pramlintide acetate injection) at that meal. Do not take more than your usual dose of SYMLIN (pramlintide acetate injection) .

Using SYMLIN (pramlintide acetate injection) and insulin with Type 2 Diabetes

  1. Start SYMLIN (pramlintide acetate injection) at 60 mcg injected under your skin, just before major meals. A major meal must have at least 250 calories or 30 grams of carbohydrate.
  2. Reduce your rapid-acting or short-acting insulin, including fixed-mix insulin such as 70/30, used before meals by 50 percent. This means half of the dose you usually use.
  3. You must check your blood sugar before and after every meal and at bedtime.
  4. Increase your dose of SYMLIN (pramlintide acetate injection) to 120 mcg on your doctor's instructions if you have not had any nausea for 3 days or more.
  5. Tell your doctor right away if you have nausea with the 120 mcg dose. Your doctor will tell you how to adjust your dose of SYMLIN (pramlintide acetate injection) .
  6. Your doctor may make changes to your insulin doses to better control your blood sugar once you are using the 120 mcg dose of SYMLIN (pramlintide acetate injection) . All insulin changes should be directed by your doctor.

Using SYMLIN (pramlintide acetate injection) and insulin with Type 1 Diabetes

  1.  Start SYMLIN (pramlintide acetate injection) at 15 mcg injected under your skin, just before major meals. A major meal must have at least 250 calories or 30 grams of carbohydrate.
  2. When starting SYMLIN (pramlintide acetate injection) , reduce your rapid-acting or short-acting insulin, including fixed-mix insulin such as 70/30, used before meals by 50 percent. This means half of the dose you usually use. All insulin changes should be directed by your doctor.
  3. You must check your blood sugar before and after every meal and at bedtime.
  4. Increase your dose of SYMLIN (pramlintide acetate injection) to 30 mcg on your doctor's instructions if you have not had any nausea for 3 days or more. If you have nausea with SYMLIN (pramlintide acetate injection) at 30 mcg, call your doctor right away. Your doctor may decide that you should stop SYMLIN (pramlintide acetate injection) .
  5. Increase your dose of SYMLIN (pramlintide acetate injection) to 45 mcg on your doctor's instructions if you have not had any nausea for 3 days or more while using the 30 mcg dose.
  6. Increase your dose of SYMLIN (pramlintide acetate injection) to 60 mcg on your doctor's instructions if you have not had any nausea for 3 days or more while using the 45 mcg dose.
  7. Call your doctor right away if you are bothered with nausea on the 45 mcg or 60 mcg dose. Your doctor may decide that you should reduce SYMLIN (pramlintide acetate injection) to the 30 mcg dose.
  8. Your doctor may make changes to your insulin doses to better control your blood sugar once you are on a dose of SYMLIN (pramlintide acetate injection) that is right for you. All insulin changes should be directed by your doctor.

Staying on SYMLIN (pramlintide acetate injection)

  • Once you reach your recommended dose of SYMLIN (pramlintide acetate injection) , talk to your doctor about changing your insulin doses to better control your blood sugar. You may have to increase your long-acting insulin to prevent high blood sugar (hyperglycemia) between meals. Insulin changes should always be directed by your doctor based on blood sugar testing.
  • Call your doctor if nausea or low blood sugar continues while on your recommended dose of SYMLIN (pramlintide acetate injection) . Low blood sugar that happens often is a warning sign of possible severe low blood sugar, especially if you have type 1 diabetes.
  • If you stop taking SYMLIN (pramlintide acetate injection) for any reason, such as surgery or illness, talk to your doctor about how to re-start SYMLIN (pramlintide acetate injection) .

When should I not use SYMLIN (pramlintide acetate injection) ?

Do not use SYMLIN (pramlintide acetate injection) if:

  • your blood sugar is too low.
  • you do not plan to eat. Do not inject SYMLIN (pramlintide acetate injection) if you skip a meal.
  • you plan to eat a meal with less than 250 calories or 30 grams of carbohydrate.
  • you are sick and can't eat your usual meal.
  • you are having surgery or a medical test where you cannot eat.
  • you are pregnant or breastfeeding and have not talked to your doctor. Talk to your doctor if you have any of these conditions.

What should I avoid while taking SYMLIN (pramlintide acetate injection) ?

  • Do not drive or operate dangerous machinery until you know how SYMLIN (pramlintide acetate injection) affects your blood sugar. Low blood sugar makes it hard to think clearly, drive a car, use heavy machinery or do other risky activities where you could hurt yourself or others. Discuss with your doctor what activities you should avoid.
  • Alcohol may increase the risk of low blood sugar.
  • Your doctor will tell you which medicines you can take while using SYMLIN (pramlintide acetate injection) . Do not take other medicines that slow stomach emptying.

What are the possible side effects of SYMLIN (pramlintide acetate injection) ?

Low blood sugar (hypoglycemia)

  • SYMLIN (pramlintide acetate injection) is used with insulin to lower your blood sugar, but your blood sugar may drop too low, especially if you have type 1 diabetes. See "What is the most important information I should know about SYMLIN (pramlintide acetate injection) ?"
  • When starting SYMLIN (pramlintide acetate injection) , reduce your doses of insulin before meals as recommended by your doctor to reduce the chance of low blood sugar. You and your doctor should talk about a plan to treat low blood sugar. You should have fast-acting sugar (such as hard candy, glucose tablets, juice) or glucagon with you at all times. Call your doctor if you have low blood sugar more often than normal or severe low blood sugar.

Your chance for low blood sugar is higher if you:

  • do not reduce your insulin dose before meals at the beginning of SYMLIN (pramlintide acetate injection) treatment, as directed by your doctor.
  • use more SYMLIN (pramlintide acetate injection) or insulin than prescribed by your doctor.
  • change your insulin dose without checking your blood sugar.
  • eat less food than your usual meal.
  • are sick and cannot eat.
  • are more active than usual.
  • have a low blood sugar level before eating.
  • drink alcohol.

Always have fast-acting sugar (such as hard candy, glucose tablets, juice) or glucagon available to treat low blood sugar.

Nausea: Nausea is the most common side effect with SYMLIN (pramlintide acetate injection) . Mild nausea is more likely during the first weeks after starting SYMLIN (pramlintide acetate injection) and usually does not last long. It is very important to start SYMLIN (pramlintide acetate injection) at a low dose and increase it as directed by your doctor. See "How should I use SYMLIN (pramlintide acetate injection) ?" If nausea continues or bothers you, call your doctor right away.

Other Side Effects: SYMLIN (pramlintide acetate injection) also may cause the following side effects: decreased appetite, vomiting, stomach pain, tiredness, dizziness, or indigestion.

SYMLIN (pramlintide acetate injection) also can cause reactions at the injection site including redness, minor bruising, or pain. See the detailed "Patient Instructions for Use." Follow the directions under "How should I use SYMLIN (pramlintide acetate injection) ?" to reduce the chance of an injection site reaction.

Tell your doctor if you have any side effects that bother you or that do not go away.

These are not all the side effects with SYMLIN (pramlintide acetate injection) . Ask your doctor or pharmacist for more information.

How should I store SYMLIN (pramlintide acetate injection) ?

  • Store SYMLIN (pramlintide acetate injection) that has not been opened in the refrigerator, between 36°F to 46°F (2°C to 8°C), until you are ready to use it. Protect SYMLIN (pramlintide acetate injection) from light.
  • After a vial or pen-injector has been used for the first time, it can be refrigerated or kept at a temperature up to 86?F (30?C) for 30 days. Do not leave above 86?F (30?C). Any vial or pen-injector in use should be thrown away after 30 days, even if it still has medicine in it.
  • Unused SYMLIN (pramlintide acetate injection) (opened or unopened) should not be used after the expiration (EXP) date printed on the carton and the label.
  • Do not freeze SYMLIN (pramlintide acetate injection) . Do not use SYMLIN (pramlintide acetate injection) if it has been frozen. Keep SYMLIN (pramlintide acetate injection) and all medicines out of the reach of children.

General information about the safe and effective use of SYMLIN (pramlintide acetate injection)

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use SYMLIN (pramlintide acetate injection) for a condition for which it was not prescribed. Do not give SYMLIN (pramlintide acetate injection) to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about SYMLIN (pramlintide acetate injection) . Also see the "Patient Instructions for Use" on using the Symlin (pramlintide acetate injection) Pen™ pen-injector or vial. You can ask your doctor for more about SYMLIN (pramlintide acetate injection) , including information that is written for doctors.

More information on SYMLIN (pramlintide acetate injection) can be found at http://www.SYMLIN (pramlintide acetate injection) .com. SYMLIN (pramlintide acetate injection) Customer Service is available 24 hours a day at 1-800-349-8919.

What are the ingredients in SYMLIN?

Active ingredient: pramlintide acetate

Inactive ingredients: metacresol, D-mannitol, acetic acid, and sodium acetate.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Patients Instructions for Use
Read the Medication Guide first.

These instructions do not take the place of talking with your doctor about your diabetes treatment. Ask your doctor about your dose and preferred injection technique. If you have questions or concerns about SYMLIN (pramlintide acetate injection) , please visit www.SYMLIN (pramlintide acetate injection) .com or call Amylin Customer Support toll free at 1-800-349-8919

Prepare and inject your dose

  1. Inspect your SYMLIN (pramlintide acetate injection) vial. The liquid in the vial should be clear and colorless.
  2. Check the expiration date (EXP) on the label to be sure your SYMLIN (pramlintide acetate injection) is not expired (see Figure A).
  3. Clean the top of the SYMLIN (pramlintide acetate injection) vial with an alcohol swab.
  4. Prepare and inject your dose - illustration 1

  5. Pull the plunger of the syringe to the line that matches your SYMLIN (pramlintide acetate injection) dose (see SYMLIN (pramlintide acetate injection) Dosing Chart and Figure B). The amount of air in the syringe should equal the amount of SYMLIN (pramlintide acetate injection) you plan to take.
  6. Prepare and inject your dose - illustration 2

  7. Push the needle through the center of the rubber top of the SYMLIN (pramlintide acetate injection) vial (see Figure C).
  8. Push the plunger to inject the air into the vial.
  9. Prepare and inject your dose - illustration 3

  10. Turn the vial and syringe upside down.
  11. Slowly pull the plunger down to draw the SYMLIN (pramlintide acetate injection) into the syringe until you have your correct dose (see Figure D).
  12. BEFORE removing the syringe from the vial, look for air bubbles inside the syringe. If you see bubbles, push the SYMLIN (pramlintide acetate injection) back into the vial. Then slowly pull the plunger down to draw the SYMLIN (pramlintide acetate injection) into the syringe until you have your correct dose.
  13. Prepare and inject your dose - illustration 4

  14. Check to be sure your dose is correct, then remove the syringe from the vial.
  15. Give your injection as directed by your healthcare provider.
  16. Dispose of the used syringe as directed by your healthcare provider.

Care and Storage

  • Store SYMLIN (pramlintide acetate injection) that has not been opened in the refrigerator, between 36°F to 46°F (2°C to 8°C), until you are ready to use it. Protect SYMLIN (pramlintide acetate injection) from light.
  • After a vial has been used for the first time, it can be refrigerated or kept at a temperature up to 86°F (30°C) for 30 days. Do not leave above 86°F (30°C).
  • Any vial in use should be thrown away after 30 days, even if it still has medicine in it.
  • Unused SYMLIN (pramlintide acetate injection) (opened or unopened) should not be used after the expiration (EXP) date printed on the carton and the label.
  • Do not freeze SYMLIN (pramlintide acetate injection) . Do not use SYMLIN (pramlintide acetate injection) if it has been frozen.
  • Keep SYMLIN (pramlintide acetate injection) and all medicines out of the reach of children

About SYMLIN (pramlintide acetate injection)

  • The way you inject SYMLIN (pramlintide acetate injection) is similar to the way you inject insulin. Inject SYMLIN (pramlintide acetate injection) under the skin (subcutaneously) of your stomach area (abdomen) or upper leg (thigh). Inject SYMLIN (pramlintide acetate injection) at a site that is more than 2 inches away from your insulin injection. To help reduce the chances of getting a reaction at the injection site, allow SYMLIN (pramlintide acetate injection) to come to room temperature before injecting. Also, use a new needle for each SYMLIN (pramlintide acetate injection) injection.
  • If you take more than your prescribed dose of SYMLIN (pramlintide acetate injection) , you may get nauseous or vomit, and you may not be able to eat the amount of food you usually eat. Pay careful attention to the amount of insulin you use at this time as you may be at more risk for low blood sugar. Contact your doctor for guidance.
  • If you miss or forget a dose of SYMLIN (pramlintide acetate injection) , wait until the next meal and take your usual dose of SYMLIN (pramlintide acetate injection) at that meal. Do not take more than your usual dose of SYMLIN (pramlintide acetate injection) .
  • Never mix SYMLIN (pramlintide acetate injection) and insulin. Use different syringes for SYMLIN (pramlintide acetate injection) and insulin. Insulin can affect SYMLIN (pramlintide acetate injection) when the two are mixed together.
  • Your prescription may be written in micrograms, and your insulin syringe is labeled in units. Use the chart below to convert micrograms to units.

SYMLIN Dosing Chart
Find Your Dose in Micrograms (meg) Draw Up This Amount in U-100 Insulin Syringe (Units)
15 mcg 2½ units
30 mcg 5 units
45 mcg 7½ units
60 mcg 10 units
120 mcg 20 units

Pen Parts - illustration

Symlin (pramlintide acetate injection) Pen™ 60 Pen-Injector Patient Instructions for Use
Read the Medication Guide first

Attach Pen Needle - illustration

Important Notes

  • Ask your doctor about your dose, injection technique, and needle size.
  • Pen may look empty because SYMLIN (pramlintide acetate injection) is a clear, colorless liquid.
  • Small bubbles will not harm you or affect your dose.
  • DO NOT TRANSFER YOUR SYMLIN (pramlintide acetate injection) FROM THE PEN TO A SYRINGE. This could result in a higher dose than intended, because the SYMLIN (pramlintide acetate injection) in the Pen is a different strength than the SYMLIN (pramlintide acetate injection) in the vial.

New Pen Setup - illustration

Routine use - illustration

Symlin (pramlintide acetate injection) Pen™ pen-injector (Pen)

Read these instructions carefully before using your Pen. Failure to follow these instructions may cause an incorrect dose, a broken Pen, or an infection.

  • Check Pen label before each use to make sure you have the 15•30•45•60 mcg Pen.
  • Check the expiration date (EXP) on the Pen label (see Pen Parts), and make sure the Pen is not expired.
  • If you drop your Pen, go to New Pen Setup to confirm Pen works.
  • If any part of your Pen appears broken or damaged, do not use.
  • This Pen is not recommended for use by blind or visually impaired persons without the assistance of a person trained in the proper use of this Pen.
  • If SYMLIN (pramlintide acetate injection) in the Cartridge (see Pen Parts) is not clear, colorless, and free of particles, do not use Pen.

Needles

  • Use a new needle for each injection. Remove the needle from the Pen after completing each injection. This will help prevent leakage of SYMLIN (pramlintide acetate injection) , keep out air bubbles, reduce needle clogs, and reduce risk of infection.
  • Pen needles are not included with the Pen. Use 29, 30, or 31 gauge disposable needles with the Pen. Ask your healthcare provider which needle gauge and length is best for you.
  • Do not share your Pen or needles with anyone.
  • Be sure the needle is completely attached to the Pen before use (see Attach Pen Needle). Do not push the Knob unless a needle is attached to Pen.
  • Throw away used needles in a puncture-resistant container or as directed by your healthcare provider. Do not throw away the Pen with a needle attached.
  • Follow local or institutional policies regarding needle handling and disposal.

Care and Storage

  • Pen that has never been used:
    -Refrigerate (36°F to 46°F, 2°C to 8°C).
    -Protect from light.
    -Do not freeze. Do not use a Pen that has been frozen.
  • Pen in use:
    -After the Pen is used for the first time (first use), refrigerate or keep at a temperature up to 86°F (30°C) for 30 days. Throw away Pen 30 days after first use, even if it still has SYMLIN (pramlintide acetate injection) in it.
  • Pen should not be used after the expiration (EXP) date printed on the label.
  • Do not store Pen with needle attached, or with Knob pulled out.
  • If needed, wipe only the outside of Pen with a clean, damp cloth (water only).
  • White particles may appear where the needle attaches during normal use. You may remove the particles with an alcohol wipe or alcohol swab.
  • Keep Pen and needles out of the reach of children.

About SYMLIN (pramlintide acetate injection)

  • The way you inject SYMLIN (pramlintide acetate injection) is similar to the way you inject insulin. Inject SYMLIN (pramlintide acetate injection) under the skin (subcutaneously) of your stomach area (abdomen) or upper leg (thigh). Inject SYMLIN (pramlintide acetate injection) at a site that is more than 2 inches away from your insulin injection. To help reduce the chances of getting a reaction at the injection site, allow SYMLIN (pramlintide acetate injection) to come to room temperature before injecting. Also, use a new needle for each SYMLIN (pramlintide acetate injection) injection.
  • If you take more than your prescribed dose of SYMLIN (pramlintide acetate injection) , you may get nauseous or vomit, and you may not be able to eat the amount of food you usually eat. Pay careful attention to the amount of insulin you use at this time as you may be at more risk for low blood sugar. Contact your doctor for guidance.
  • If you miss or forget a dose of SYMLIN (pramlintide acetate injection) , wait until the next meal and take your usual dose of SYMLIN (pramlintide acetate injection) at that meal. Do not take more than your usual dose of SYMLIN (pramlintide acetate injection) .

Questions and Answers (Q&A)

Why does my new Pen look empty?

  • Because SYMLIN (pramlintide acetate injection) is clear and colorless, the Cartridge (see Pen Parts) may look empty, even though there is medicine in it.
  • To be sure there is SYMLIN (pramlintide acetate injection) in the Cartridge, perform Pen setup (see New Pen Setup).

What should I do if I see air bubbles?

  • The Cartridge may contain small air bubbles. Small air bubbles are normal and will not harm you or affect your dose.
  • Perform New Pen Setup before the first dose with each new Pen (see New Pen Setup).
  • To prevent more air bubbles, do NOT store Pen with needle attached.

Why can't I turn the Dial?

  • If the Knob has been pulled out, the Dial will not move and you cannot reset your dose. Push in the Knob to discard the dose and repeat the instructions (see Routine Use).
  • If the Knob is pushed in all the way, and you cannot rotate the Dial, call Amylin Customer Support.

What should I do if I do not see a stream of liquid when I perform the setup?

  • Watch for a stream when you start to push the Knob.
  • The liquid is clear and colorless, so it may be difficult to see.
  • Pull out the Knob all the way - you will hear clicking.
  • Firmly push in the Knob all the way- you will hear clicking.
  • If there is no stream of liquid after 6 attempts, replace the needle and repeat setup.
  • If still no stream, call Amylin Customer Support.

What should I do if I load an incorrect dose?

  • Do not inject an incorrect dose. Point the needle away from you and discard the dose by pushing in the Knob all the way. Dial your correct dose.

How do I make sure I am getting my correct dose of SYMLIN (pramlintide acetate injection) ?

  • Before pulling out Knob, be sure the number in Window matches your prescribed SYMLIN (pramlintide acetate injection) dose (see Figure A).
  • Pull out the Knob all the way - you will hear clicking (see Figure B).
  • Be sure that number on the Dose Check matches your dose in Window.
    You must see line, arrow, and number on Dose Check (see Figure C).
  • Firmly push in the Knob all the way - you will hear clicking.
  • Hold Knob for 10 seconds before removing needle from skin (see Figure E).

Why do I see SYMLIN (pramlintide acetate injection) leaking from my needle after I inject?

  • You may see one or two drops - this is normal.
  • If you see more than 2 drops:
    -You may not have received your full dose.
    -Do not inject another dose.
    -Talk to your healthcare provider.
  • To prevent dripping or leaking, be sure to firmly push and hold Knob with your thumb for 10 seconds before removing needle from skin.

How do I know when my pen is empty?

  • Check Your Dose after pulling out the Knob (see Figure C).
  • The lines on the Cartridge show approximately how much SYMLIN (pramlintide acetate injection) is left in the Pen. When the Plunger is at the thickest line on the Cartridge, your Pen is almost empty (see Figure F).

How to know when the pen is empty - illustration 1

  • If you cannot see the line, arrow, and number that match your prescribed dose, you do not have enough SYMLIN (pramlintide acetate injection) to give your full dose (see Figure H). Throw away this Pen, and use a new Pen to give your dose.

How to know when the pen is empty - illustration 2

The Patient Instructions for Use do not take the place of talking with your doctor about your diabetes treatment. Ask your doctor about your dose and preferred injection technique. If you are having problems using your Pen, please visit www.SYMLIN (pramlintide acetate injection) .com or call Amylin Customer Support toil free at 1-800-349-8919.

Pen parts - illustration

Symlin (pramlintide acetate injection) Pen™ 120 Pen-Injector Patient Instructions for Use
Read the Medication Guide first

Attach pen needle - illustration

Important Notes

  • Ask your doctor about your dose, injection technique, and needle size.
  • Pen may look empty because SYMLIN (pramlintide acetate injection) is a clear, colorless liquid.
  • Small bubbles will not harm you or affect your dose.
  • DO NOT TRANSFER YOUR SYMLIN (pramlintide acetate injection) FROM THE PEN TO A SYRINGE. This could result in a higher dose than intended, because the SYMLIN (pramlintide acetate injection) in the Pen is a different strength than the SYMLIN (pramlintide acetate injection) in the vial.

New pen setup - illustration

routine use - illustration

Symlin (pramlintide acetate injection) Pen™ pen-injector (Pen)

Read these instructions carefully before using your Pen. Failure to follow these instructions may cause an incorrect dose, a broken Pen, or an infection.

  • Check Pen label before each use to make sure you have the 60•120 mcg Pen.
  • Check the expiration date (EXP) on the Pen label (see Pen Parts), and make sure the Pen is not expired.
  • If you drop your Pen, go to New Pen Setup to confirm Pen works.
  • If any part of your Pen appears broken or damaged, do not use.
  • This Pen is not recommended for use by blind or visually impaired persons without the assistance of a person trained in the proper use of this Pen.
  • If SYMLIN (pramlintide acetate injection) in the Cartridge (see Pen Parts) is not clear, colorless, and free of particles, do not use Pen.

Needles

  • Use a new needle for each injection. Remove the needle from the Pen after completing each injection. This will help prevent leakage of SYMLIN (pramlintide acetate injection) , keep out air bubbles, reduce needle clogs, and reduce risk of infection.
  • Pen needles are not included with the Pen. Use 29, 30, or 31 gauge disposable needles with the Pen. Ask your healthcare provider which needle gauge and length is best for you.
  • Do not share your Pen or needles with anyone.
  • Be sure the needle is completely attached to the Pen before use (see Attach Pen Needle). Do not push the Knob unless a needle is attached to Pen.
  • Throw away used needles in a puncture-resistant container or as directed by your healthcare provider. Do not throw away the Pen with a needle attached.
  • Follow local or institutional policies regarding needle handling and disposal.

Care and Storage

  • Pen that has never been used:
    -Refrigerate (36°F to 46°F, 2°C to 8°C).
    -Protect from light.
    -Do not freeze. Do not use a Pen that has been frozen.
  • Pen in use:
    -After the Pen is used for the first time (first use), refrigerate or keep at a temperature up to 86°F (30°C) for 30 days. Throw away Pen 30 days after first use, even if it still has SYMLIN (pramlintide acetate injection) in it.
  • Pen should not be used after the expiration (EXP) date printed on the label.
  • Do not store Pen with needle attached, or with Knob pulled out.
  • If needed, wipe only the outside of Pen with a clean, damp cloth (water only).
  • White particles may appear where the needle attaches during normal use. You may remove the particles with an alcohol wipe or alcohol swab.
  • Keep Pen and needles out of the reach of children.

About SYMLIN (pramlintide acetate injection)

  • The way you inject SYMLIN (pramlintide acetate injection) is similar to the way you inject insulin. Inject SYMLIN (pramlintide acetate injection) under the skin (subcutaneously) of your stomach area (abdomen) or upper leg (thigh). Inject SYMLIN (pramlintide acetate injection) at a site that is more than 2 inches away from your insulin injection. To help reduce the chances of getting a reaction at the injection site, allow SYMLIN (pramlintide acetate injection) to come to room temperature before injecting. Also, use a new needle for each SYMLIN (pramlintide acetate injection) injection.
  • If you take more than your prescribed dose of SYMLIN (pramlintide acetate injection) , you may get nauseous or vomit, and you may not be able to eat the amount of food you usually eat. Pay careful attention to the amount of insulin you use at this time as you may be at more risk for low blood sugar. Contact your doctor for guidance.
  • If you miss or forget a dose of SYMLIN (pramlintide acetate injection) , wait until the next meal and take your usual dose of SYMLIN (pramlintide acetate injection) at that meal. Do not take more than your usual dose of SYMLIN (pramlintide acetate injection) .

Questions and Answers (Q&A)

Why does my new Pen look empty?

  • Because SYMLIN (pramlintide acetate injection) is clear and colorless, the Cartridge (see Pen Parts) may look empty, even though there is medicine in it.
  • To be sure there is SYMLIN (pramlintide acetate injection) in the Cartridge, perform Pen setup (see New Pen Setup).

What should I do if I see air bubbles?

  • The Cartridge may contain small air bubbles. Small air bubbles are normal and will not harm you or affect your dose.
  • Perform New Pen Setup before the first dose with each new Pen (see New Pen Setup).
  • To prevent more air bubbles, do NOT store Pen with needle attached.

Why can't I turn the Dial?

  • If the Knob has been pulled out, the Dial will not move and you cannot reset your dose. Push in the Knob to discard the dose and repeat the instructions (see Routine Use).
  • If the Knob is pushed in all the way, and you cannot rotate the Dial, call Amylin Customer Support.

What should I do if I do not see a stream of liquid when I perform the setup?

  • Watch for a stream when you start to push the Knob.
  • The liquid is clear and colorless, so it may be difficult to see.
  • Pull out the Knob all the way - you will hear clicking.
  • Firmly push in the Knob all the way- you will hear clicking.
  • If there is no stream of liquid after 3 attempts, replace the needle and repeat setup.
  • If still no stream, call Amylin Customer Support.

What should I do if I load an incorrect dose?

  • Do not inject an incorrect dose. Point the needle away from you and discard the dose by pushing in the Knob all the way. Dial your correct dose.

How do I make sure I am getting my correct dose of SYMLIN (pramlintide acetate injection) ?

  • Before pulling out Knob, be sure the number in Window matches your prescribed SYMLIN (pramlintide acetate injection) dose (see Figure A).
  • Pull out the Knob all the way - you will hear clicking (see Figure B).
  • Be sure that number on the Dose Check matches your dose in Window.

You must see line, arrow, and number on Dose Check (see Figure C).

  • Firmly push in the Knob all the way - you will hear clicking.
  • Hold Knob for 10 seconds before removing needle from skin (see Figure E).

Why do I see SYMLIN (pramlintide acetate injection) leaking from my needle after I inject?

  • You may see one or two drops
    - this is normal.
  • If you see more than 2 drops:
    -You may not have received your full dose.
    -Do not inject another dose.
    -Talk to your healthcare provider.
  • To prevent dripping or leaking, be sure to firmly push and hold Knob with your thumb for 10 seconds before removing needle from skin.

How do I know when my pen is empty?

  • Check Your Dose after pulling out the Knob (see Figure C).
  • The lines on the Cartridge show approximately how much SYMLIN (pramlintide acetate injection) is left in the Pen. When the Plunger is at the thickest line on the Cartridge, your Pen is almost empty (see Figure F).

How to know when the pen is empty - illustration 1

  • If you cannot see the line, arrow, and number that match your prescribed dose, you do not have enough SYMLIN (pramlintide acetate injection) to give your full dose (see Figure H). Throw away this Pen, and use a new Pen to give your dose.

How to know when the pen is empty - illustration 2

The Patient Instructions for Use do not take the place of talking with your doctor about your diabetes treatment. Ask your doctor about your dose and preferred injection technique. If you are having problems using your Pen, please visit www.SYMLIN (pramlintide acetate injection) .com or call Amylin Customer Support toll free at 1 -800-349-8919.

Last reviewed on RxList: 4/9/2008
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Symlin Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

PRAMLINTIDE VIAL - INJECTION

(PRAM-lin-tide)

COMMON BRAND NAME(S): Symlin

WARNING: Pramlintide may increase the risk of very low blood sugar when used with insulin, particularly in patients with type 1 diabetes. This reaction is most likely to occur within 3 hours after an injection. Your doctor may decrease your insulin dose when you start pramlintide. Low blood sugar makes it hard to think clearly, drive a car, use heavy machinery, or safely participate in other activities that include a risk of hurting yourself or others. (See also Side Effects and Precautions sections.)

USES: Pramlintide is used with mealtime insulin and a proper diet and exercise program to control high blood sugar in people with type 1 and type 2 diabetes. It is used when patients who are already using insulin need better blood sugar control. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke.

Pramlintide acts like a certain natural substance called amylin, which lowers blood sugar. This drug works by slowing the movement of food through your stomach. It also decreases your appetite and the amount of sugar your liver makes. Pramlintide does not replace insulin, but it may lower the amount of insulin you need.

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using pramlintide and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Inject this medication under the skin of the thigh or abdomen just before each main meal. Do not use pramlintide if your blood sugar is too low, if you are planning to eat a small meal (less than 250 calories or 30 grams of carbohydrate), or if you are skipping a meal.

The liquid in the pre-filled injector is stronger than the liquid in the vial. Make sure you are using the correct product. Do not switch between products unless directed by your doctor.

Make sure you learn from your health care professional how to measure your dose and inject this drug. You will be using an insulin syringe to measure your dose. However, it is very important to remember that pramlintide is measured differently in the syringe than insulin. It is easy to make a mistake and use too much pramlintide. Therefore, carefully read the dosing table in the Medication Guide to find your correct dose of pramlintide, and make sure you understand how to measure your dose of pramlintide. Always use a new syringe and needle for each injection. Consult your doctor or pharmacist if you have any questions. If you are storing this drug in the refrigerator, remove it and allow it to come to room temperature before injecting. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the injection site with rubbing alcohol. It is important to change the location of the injection site daily to avoid problems under the skin. Never mix pramlintide and insulin in the same syringe or at the same injection site. Inject pramlintide in an area that is at least 2 inches (5 centimeters) away from your insulin injection site.

Your dosage is based on your medical condition, use of other medications, and response to treatment. To reduce the risk of nausea, your doctor may direct you to start at a low dose of pramlintide and gradually increase the dose. Your doctor may also direct you to lower your insulin dose and to check you blood sugar more often. Do not change your dosage without consulting your doctor. Use this medication regularly in order to get the most benefit from it.

Learn how to store and discard needles and medical supplies safely. Consult your pharmacist.

Disclaimer

Symlin Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, tiredness, and upset stomach may occur as your body adjusts to the medication. Nausea can be reduced by starting at a low dose and increasing the dose slowly. Redness, swelling, and itching at the injection site may occur and usually go away in a few days. If any of these effects persist or worsen, contact your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Though pramlintide does not cause low blood sugar (hypoglycemia) by itself, this effect can occur because it is used with insulin. This may also occur if you do not consume enough calories from food or if you do unusually heavy exercise. Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor immediately about the reaction and the use of this product. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist to find out what you should do if you miss a meal.

Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor immediately. Your dosage may need to be increased.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Symlin (pramlintide acetate injection) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before using pramlintide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as the preservative metacresol), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medication, consult your doctor or pharmacist if you have: stomach/intestinal disorders (e.g., digestion problems such as gastroparesis).

This medication should not be used by people who are unable to tell when they have symptoms of low blood sugar (e.g., children).

Before using pramlintide, tell your doctor or pharmacist your medical history, especially of: attacks of low blood sugar (hypoglycemia) that required treatment.

You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar levels. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages because alcohol can affect your blood sugar.

It may be harder to control your blood sugar when your body is stressed (e.g., due to fever, infection, injury, or surgery). Consult your doctor because this may require a change in your treatment plan, medications, or blood sugar testing.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if pramlintide passes into breast milk. Consult your doctor before breast-feeding.

Disclaimer

Symlin Consumer (continued)

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: anti-diabetic drugs (e.g., alpha glucosidase inhibitors such as acarbose/miglitol), drugs for high blood pressure that may make it harder to notice symptoms of low blood sugar (e.g., clonidine, guanethidine, reserpine), drugs that slow down or speed up movement of food through your stomach (causing constipation or diarrhea such as atropine, exenatide, metoclopramide), quinolone antibiotics (e.g., levofloxacin, moxifloxacin).

Some other medications may not work as well if used at the same time as pramlintide. If you are using any of the following drugs, take them at least 1 hour before or 2 hours after your injection: antibiotics, birth control pills, pain relievers (e.g., acetaminophen).

If you have any questions about when to take your other medications, ask your pharmacist.

If you are using a medication that needs to be taken with food, take it with a small meal or snack (less than 250 calories or 30 grams of carbohydrate) at a time when you do not normally inject pramlintide.

Beta blocker medications (e.g., metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood sugar level falls too low (hypoglycemia). Other symptoms of low blood sugar such as dizziness, hunger, or sweating are unaffected by these drugs.

Many drugs can affect your blood sugar levels, making it more difficult to control your blood sugar. Before you start, stop, or change any medication, talk with your doctor or pharmacist about how the medication may affect your blood sugar. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor about the results and of any symptoms of high or low blood sugar. (See also Side Effects section.) Your doctor may need to adjust your anti-diabetic medication, exercise program, or diet.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe nausea, vomiting, diarrhea, flushing, dizziness.

NOTES: Do not share this medication, syringes, or needles with others.

You should attend a diabetes education program to understand diabetes, its complications, and all the important aspects of its treatment, including meals/diet, exercise, personal hygiene, medications, and getting regular eye, foot, and medical exams.

Keep all medical appointments. Laboratory and/or medical tests (e.g., fasting blood glucose, hemoglobin A1c) should be performed periodically to monitor for side effects and response to treatment. Check your blood sugar levels regularly before and after meals and at bedtime or as directed by your doctor or pharmacist.

MISSED DOSE: If you miss a dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store unopened vials of pramlintide in the refrigerator at 36-46 degrees F (2-8 degrees C). Protect from light. Do not freeze. Discard vials that have been frozen or overheated. Opened vials that you are currently using can be stored in the refrigerator or at room temperature for up to 30 days as long as the temperature is not higher than 86 degrees F (30 degrees C). Discard the vial 30 days after it has been opened (punctured) whether or not it has been refrigerated, even if some drug remains in the vial. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Information last revised May 2012. Copyright(c) 2012 First Databank, Inc.

Symlin Patient Information Including Side Effects

Brand Names: Symlin, SymlinPen 120, SymlinPen 60

Generic Name: pramlintide (Pronunciation: PRAM lin tide)

What is pramlintide (Symlin)?

Pramlintide is a man-made form of a hormone that occurs naturally in the body. Pramlintide lowers blood sugar in three ways. It slows the rate that food moves from your stomach to your intestines, which keeps your blood sugar from rising too fast. Pramlintide also lowers the amount of glucose (sugar) your liver produces. Lastly, pramlintide triggers the feeling of fullness after meals to help control your appetite and decrease how much food you eat.

Pramlintide is used together with insulin to treat type 1 or type 2 diabetes.

Pramlintide may also be used for other purposes not listed in this medication guide.

What are the possible side effects of pramlintide (Symlin)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • severe nausea that lasts for 3 to 7 days; or
  • more frequent high blood sugar levels.

Less serious side effects may include:

  • runny or stuffy nose, sore throat, cough;
  • nausea, loss of appetite;
  • headache, tired feeling; or
  • joint pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Symlin (pramlintide acetate injection) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about pramlintide (Symlin)?

Do not mix pramlintide and insulin together in the same syringe.

You will need to use a lower dose of insulin than you used before you started using pramlintide. Your doctor will determine your correct dose.

Call your doctor if you have severe nausea that lasts for several days. This may be a sign that your dose is too high.

If you stop using pramlintide for a short time, you may need to restart the medication at a lower dose. Do not change your doses or medication schedule without your doctor's advice.

Take care not to let your blood sugar get too low, causing hypoglycemia. Severe hypoglycemia may occur within 3 hours after your pramlintide injection. Carry hard candy or glucose tablets with you in case you have low blood sugar. Be sure your family and close friends know how to help you in an emergency.

Side Effects Centers

Symlin Patient Information including How Should I Take

What should I discuss with my doctor before using pramlintide (Symlin)?

Do not use this medication if you are allergic to pramlintide or metacresol. Do not use if you have a digestive condition called "delayed gastric emptying," or if you cannot recognize symptoms of low blood sugar.

If you have any of these other conditions, you may need a pramlintide dose adjustment or special tests:

  • a history of delayed gastric emptying;
  • if you are unable to check your blood sugars regularly up to several times daily;
  • if you have had severe hypoglycemia more than once in the past 6 months;

FDA pregnancy category C. It is not known whether pramlintide will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication..

It is not known whether pramlintide passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Pramlintide should not be used in children.

How should I use pramlintide (Symlin)?

Use pramlintide exactly as it was prescribed for you. Do not use the medication in larger or smaller amounts, or use it for longer than recommended by your doctor. You may not be able to keep using pramlintide if you do not follow the dosing instructions.

Pramlintide is injected under the skin, at the same time as your insulin injection but in a separate syringe or injector pen. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes. Do not mix pramlintide and insulin together in the same syringe.

Use only the syringe or injection pen recommended by your doctor. Ask your pharmacist about which needles to buy for proper use of the syringe or injection pen.

Pramlintide is usually given just before each major meal. Follow your doctor's instructions. If you skip a meal, do not take your dose of pramlintide. Wait until your next meal.

Pramlintide should be at room temperature when you inject it.

Use a different place on your stomach or thigh each time you give the injection. Inject your insulin in a separate skin area. Do not inject insulin or pramlintide into the same place two times in a row. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.

Use a disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Call your doctor if you have severe nausea that lasts for several days. This may be a sign that your dose is too high.

If you stop using pramlintide for a short time, you may need to restart the medication at a lower dose. Follow your doctor's instructions.

You will need to use a lower dose of insulin than you used before you started using pramlintide. Your doctor will determine the correct insulin dose based on the type of diabetes you have.

Do not change your doses or medication schedule without your doctor's advice. Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office. Visit your doctor regularly.

Take care not to let your blood sugar get too low, causing hypoglycemia. Severe hypoglycemia may occur within 3 hours after your pramlintide injection. Symptoms include headache, hunger, sweating, tremor, irritability, or trouble concentrating. Carry hard candy or glucose tablets with you in case you have low blood sugar. Be sure your family and close friends know how to help you in an emergency.

Severe hypoglycemia may cause loss of consciousness, seizures, or death. If you have severe hypoglycemia and cannot eat or drink, use an injection of glucagon. Your doctor can give you a prescription for a glucagon emergency injection kit and tell you how to give the injection.

Do not freeze pramlintide, and throw away the medication if it has become frozen.

Storing after your first use: You may keep "in-use" vials or injection pens in the refrigerator or at room temperature. Use within 30 days.

Side Effects Centers

Symlin Patient Information including If I Miss a Dose

What happens if I miss a dose (Symlin)?

Take the missed dose as soon as you remember, but only if you are getting ready to eat a meal. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Symlin)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose may cause diarrhea, vomiting, dizziness, cold sweats, warmth or tingly feeling.

What should I avoid while using pramlintide (Symlin)?

Do not remove pramlintide from an injector pen and put it in a syringe. You may receive too high a dose.

Avoid drinking alcohol. It can lower your blood sugar.

What other drugs will affect pramlintide (Symlin)?

The following drugs can interact with pramlintide. Tell your doctor if you are using any of these:

  • acarbose (Precose) or miglitol (Glyset);
  • disopyramide (Norpace);
  • fluoxetine (Luvox);
  • pentoxyfylline (Trental);
  • propoxyphene (Darvon, Darovcet);
  • diabetes medications you take by mouth;
  • atropine (Atreza, Sal-Tropine), dicyclomine (Bentyl), hyoscyamine (Hyomax), oxybutynin (Ditropan, Oxytrol);
  • an ACE inhibitor such as benazepril (Lotensin), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), quinapril (Accupril), ramipril (Altace), and others; or
  • cholesterol-lowering medication such as fenofibrate (Lofibra, Fenoglide, TriCor, Lipofen) or gemfibrozil (Lopid).

Using certain medicines can make it harder for you to tell when you have low blood sugar. Tell your doctor if you use any of the following:

  • albuterol (Proventil, Ventolin);
  • clonidine (Catapres); or
  • a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others.

You may be more likely to have high or low blood sugar if you are using pramlintide with other drugs that raise or lower blood sugar. This includes:

  • isoniazid;
  • probenecid (Benemid);
  • aspirin or other salicylates (including Pepto-Bismol);
  • birth control pills and other hormones;
  • diet pills or medicines to treat asthma, colds or allergies;
  • diuretics (water pills);
  • a monoamine oxidase inhibitor (MAOI);
  • phenothiazines (Compazine and others);
  • steroids (prednisone and others);
  • seizure medicines (Dilantin and others);
  • some nonsteroidal anti-inflammatory drugs (NSAIDs); and
  • sulfa drugs (Bactrim, Gantanol, Gantrisin, Septra, SMX-TMP, and others).

These lists are not complete and other drugs may interact with pramlintide. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about pramlintide.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 3.03. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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Side Effects Centers

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