لانتوس
Insulin Glargine [rDNA origin] Injection (Lantus)
لانتوس

نام ژنریک

Insulin Glargine

شکل دارویی

اشكال دارويي:


Injection: 100 IU/ml, 10ml, 100 IU/ml, 3ml, 100 IU/ml, 3ml (Prefilled Disposable Pen)

موارد مصرف

موارد و مقدار مصرف


الف) كنترل ديابت تيپ 1 در بيماراني كه به انسولين پايه (طولاني اثر) براي كنترل قند خون خود نياز دارند.


بزرگسالان و كودكان بالاي 6 سال: دوز دارو به صورت فردي تنظيم مي‌شود. دارو به صورت زيرجلدي و يك بار در روز تزريق مي‌شود (هر روز در زمان يكسان).


ب) كنترل ديابت تيپ 2 در بيماراني كه به انسولين پايه (طولاني اثر) براي كنترل قند خون خود نياز دارند.


بزرگسالان: دوز به صورت فردي تنظيم مي‌گردد. دارو به صورت زيرجلدي و يك بار در روز تزريق شود (هر روز در زمان يكسان).

موارد منع مصرف

موارد منع مصرف و احتياط


موارد منع مصرف: حساسيت مفرط به انسولين گلارژين و ساير تركيبات آن و افت قند خون.


موارد احتياط: نارسايي كبد و كليه.

عوارض جانبی دارو

عوارض جانبي


متابوليك: كاهش قند خون.


پوست: ليپوديستروفي، خارش، راش، درد در محل تزريق.


ساير عوارض: واكنش‌هاي آلرژيك.


مسموميت و درمان


مشابه انسولين رگولار.

موارد قابل توجه

-

تداخل دارویی

تداخل دارويي


مشابه انسولين رگولار

مکانیزم اثر

تداخل دارويي


مشابه انسولين رگولار

فارماكوكینتیك

فارماكوكينتيك


جذب: پس از تزريق زيرجلدي، انسولين گلارژين. جذب آهسته‌تر و طول كشيده‌تري نسبت به NPH دارد و بيشتر از 24 ساعت يك سطح نسبتاً ثابت زمان و بدون پيك دارد.


پخش: اطلاعي در دست نيست.


متابوليسم: قسمتي از آن به دو نوع متابوليت فعال بدون فعاليت invitro و مشابه انسولين تبديل مي‌شود.


دفع: اطلاعي در دست نيست.

سایر اطلاعات

طبقه‌بندي فارماكولوژيك: هورمون پانكراس.


طبقه‌بندي درماني: ضد قند.


طبقه‌بندي مصرف در بارداري: رده C


نام‌هاي تجاري: Lantus, Lantus Solostar


ملاحظات اختصاصي


1- ملاحظات مربوط به انسولين رگولار


2- انسولين گلارژين به صورت وريدي تزريق نمي‌شود و تنها به فرم زيرجلدي تجويز مي‌گردد.


3- در صورت تبديل انسولين از NPH به گلارژين، با 80% دوز NPH روزانه درمان شروع گردد.


4- به علت طول اثر طولاني گلارژين، اين دارو، انسولين انتخابي براي كتواسيدوز ديابتي نمي‌باشد.


5- طول اثر دارو به تزريق مناسب در فضاي زيرجلدي وابسته است.


6- انسولين گلارژين با هيچ انسولين ديگري نبايد مخلوط شود.


نكات قابل توصيه به بيمار


1- مشابه انسولين رگولار


2- ويالهاي باز نشده بايد در دماي يخچال (8-2 درجه سانتي‌گراد ) نگهداري شود و نبايد در فريزر و در محل قابل انجماد نگهداري شود.


ويالهاي باز نشده چه در يخچال نگهداري شده باشند چه نباشند بايد پس از 28 روز دور انداخته شوند.


ويالهاي باز شده مي‌توانند در دماي 30 درجه سانتي‌گراد و يا پايين‌تر به دور از نور و گرماي مستقيم نگهداري شود.


مصرف در سالمندان: از آنجايي كه تشخيص افت قند خون در سالمندان مبتلا به ديابت مشكل است دوز شروع دارو، ميزان افزايش دوز و دوز نگهدارنده بايد با احتياط انتخاب گردد.


مصرف در كودكان: ايمني و كارايي اين دارو در كودكان 15-6 سال مبتلا به ديابت تيپ 1 ثابت شده است. ايمني و كارايي گلارژين در كودكان زير 6 سال مطالعه نشده است. براساس مطالعات دوز پيشنهادي در اطفال مشابه بزرگسالان است.


مصرف در شيردهي: ترشح قابل توجه دارو در شير مشخص نيست، از آنجايي كه انسولين انسان وارد شير مي‌گردد توصيه مي‌شود گلارژين در شيردهي با احتياط مصرف شود. خانمهاي شيرده نياز به تنظيم دوز مجدد و تنظيم رژيم غذايي در اين دوران دارند.


اثر بر آزمايشهاي تشخيصي


ممكن است باعث كاهش سطح گلوكز شود.

Insulin Glargine [rDNA origin] Injection (Lantus)

LANTUS®
(insulin glargine [rDNA origin]) Injection

LANTUS® must NOT be diluted or mixed with any other insulin or solution.

DRUG DESCRIPTION

LANTUS® is a sterile solution of insulin glargine for use as an injection. Insulin glargine is a recombinant human insulin analog that is a long-acting (up to 24-hour duration of action), parenteral blood-glucose-lowering agent. (See CLINICAL PHARMACOLOGY). LANTUS (insulin glargine rdna origin injection) is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli (K12) as the production organism. Insulin glargine differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Chemically, it is 21A- Gly-30Ba-L-Arg-30Bb-L-Arg-human insulin and has the empirical formula C267H404N72O78S6 and a molecular weight of 6063. It has the following structural formula:

LANTUS® structural formula illustration

LANTUS (insulin glargine rdna origin injection) consists of insulin glargine dissolved in a clear aqueous fluid. Each milliliter of LANTUS (insulin glargine rdna origin injection) contains 100 IU (3.6378 mg) insulin glargine.

Inactive ingredients for the 10 mL vial are 30 mcg zinc, 2.7 mg m-cresol, 20 mg glycerol 85%, 20 mcg polysorbate 20, and water for injection.

Inactive ingredients for the 3 mL cartridge are 30 mcg zinc, 2.7 mg m-cresol, 20 mg glycerol 85%, and water for injection.

The pH is adjusted by addition of aqueous solutions of hydrochloric acid and sodium hydroxide. LANTUS (insulin glargine rdna origin injection) has a pH of approximately 4.

What are the possible side effects of insulin glargine (Lantus, Lantus OptiClik Cartridge, Lantus Solostar Pen)?

Get emergency medical help if you have any of these signs of insulin allergy: itching skin rash over the entire body, wheezing, trouble breathing, fast heart rate, sweating, or feeling like you might pass out.

Hypoglycemia, or low blood sugar, is the most common side effect of insulin glargine. Symptoms include headache, hunger, weakness, sweating, tremors, irritability, trouble concentrating, rapid breathing, fast heartbeat, fainting, or seizure (severe hypoglycemia can be fatal). Carry hard candy or glucose tablets...

Read All Potential Side Effects and See Pictures of Lantus »

What are the precautions when taking insulin glargine [rdna origin] injection (Lantus)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease.

Use only the insulin product that your doctor has prescribed for you. Do not change the insulin you use unless your doctor has given you instructions on how to do so. Follow your doctor's instructions carefully. Following a change in insulin, you may need a dosage change. Know the symptoms of low blood sugar and high blood sugar (see Side Effects section). Tell your doctor...

Read All Potential Precautions of Lantus »

Last reviewed on RxList: 1/14/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

LANTUS (insulin glargine [rdna origin] injection) is indicated for once-daily subcutaneous administration for the treatment of adult and pediatric patients with type 1 diabetes mellitus or adult patients with type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia.

DOSAGE AND ADMINISTRATION

LANTUS (insulin glargine [rdna origin] injection) is a recombinant human insulin analog. Its potency is approximately the same as human insulin. It exhibits a relatively constant glucose-lowering profile over 24 hours that permits once-daily dosing.

LANTUS (insulin glargine [rdna origin] injection) may be administered at any time during the day. LANTUS (insulin glargine [rdna origin] injection) should be administered subcutaneously once a day at the same time every day. For patients adjusting timing of dosing with LANTUS, see WARNINGS and PRECAUTIONS, Hypoglycemia. LANTUS (insulin glargine [rdna origin] injection) is not intended for intravenous administration (see PRECAUTIONS). Intravenous administration of the usual subcutaneous dose could result in severe hypoglycemia. The desired blood glucose levels as well as the doses and timing of antidiabetes medications must be determined individually. Blood glucose monitoring is recommended for all patients with diabetes. The prolonged duration of activity of LANTUS (insulin glargine [rdna origin] injection) is dependent on injection into subcutaneous space.

As with all insulins, injection sites within an injection area (abdomen, thigh, or deltoid) must be rotated from one injection to the next.

In clinical studies, there was no relevant difference in insulin glargine absorption after abdominal, deltoid, or thigh subcutaneous administration. As for all insulins, the rate of absorption, and consequently the onset and duration of action, may be affected by exercise and other variables.

LANTUS (insulin glargine [rdna origin] injection) is not the insulin of choice for the treatment of diabetes ketoacidosis. Intravenous short-acting insulin is the preferred treatment.

Pediatric Use

LANTUS (insulin glargine [rdna origin] injection) can be safely administered to pediatric patients ≥ 6 years of age. Administration to pediatric patients < 6 years has not been studied. Based on the results of a study in pediatric patients, the dose recommendation for changeover to LANTUS (insulin glargine [rdna origin] injection) is the same as described for adults in DOSAGE AND ADMINISTRATION, Changeover to LANTUS (insulin glargine [rdna origin] injection) .

Initiation of LANTUS (insulin glargine [rdna origin] injection) Therapy

In a clinical study with insulin naïve patients with type 2 diabetes already treated with oral antidiabetes drugs, LANTUS (insulin glargine [rdna origin] injection) was started at an average dose of 10 IU once daily, and subsequently adjusted according to the patient's need to a total daily dose ranging from 2 to 100 IU.

Changeover to LANTUS (insulin glargine [rdna origin] injection)

If changing from a treatment regimen with an intermediate- or long-acting insulin to a regimen with LANTUS (insulin glargine [rdna origin] injection) , the amount and timing of short-acting insulin or fast-acting insulin analog or the dose of any oral antidiabetes drug may need to be adjusted. In clinical studies, when patients were transferred from once-daily NPH human insulin or ultralente human insulin to once-daily LANTUS (insulin glargine [rdna origin] injection) , the initial dose was usually not changed. However, when patients were transferred from twice-daily NPH human insulin to LANTUS (insulin glargine [rdna origin] injection) once daily, to reduce the risk of hypoglycemia, the initial dose (IU) was usually reduced by approximately 20% (compared to total daily IU of NPH human insulin) and then adjusted based on patient response (see PRECAUTIONS, Hypoglycemia).

A program of close metabolic monitoring under medical supervision is recommended during transfer and in the initial weeks thereafter. The amount and timing of short-acting insulin or fast- acting insulin analog may need to be adjusted. This is particularly true for patients with acquired antibodies to human insulin needing high-insulin doses and occurs with all insulin analogs. Dose adjustment of LANTUS (insulin glargine [rdna origin] injection) and other insulins or oral antidiabetes drugs may be required; for example, if the patient's timing of dosing, weight or lifestyle changes, or other circumstances arise that increase susceptibility to hypoglycemia or hyperglycemia (see PRECAUTIONS, Hypoglycemia).

The dose may also have to be adjusted during intercurrent illness (see PRECAUTIONS, Intercurrent Conditions).

Preparation and Handling

Parenteral drug products should be inspected visually prior to administration whenever the solution and the container permit. LANTUS (insulin glargine [rdna origin] injection) must only be used if the solution is clear and colorless with no particles visible.

Mixing and diluting: LANTUS (insulin glargine [rdna origin] injection) must NOT be diluted or mixed with any other insulin or solution (see PRECAUTIONS, General).

Vial: The syringes must not contain any other medicinal product or residue.

Cartridge system/SoloStar: If OptiClik®, the Insulin Delivery Device used with the LANTUS (insulin glargine [rdna origin] injection) cartridge system, or SoloStar, disposable insulin device, malfunctions, LANTUS (insulin glargine [rdna origin] injection) may be drawn from the cartridge system or from SoloStar into a U-100 syringe and injected.

HOW SUPPLIED

LANTUS (insulin glargine [rdna origin] injection) 100 units per mL (U-100) is available in the following package size:

10 mL vials (NDC 0088-2220-33)
3 mL cartridge system*, package of 5 (NDC 0088-2220-52)

Needles are not included in the packs.

BD Ultra-Fine™ needles to be used in conjunction with SoloStar and OptiClik are sold separately and are manufactured by BD.

*Cartridge systems are for use only in OptiClik® (Insulin Delivery Device) 3 mL SoloStar® disposable insulin device, package of 5 (NDC 0088-2220-60)
The brands listed are the trademarks of their respective owners and are not trademarks of sanofi-aventis U.S. LLC

Storage

Unopened Vial/Cartridge system/SoloStar® disposable insulin device

Unopened LANTUS (insulin glargine [rdna origin] injection) vials, cartridge systems and SoloStar® should be stored in a refrigerator, 36°F - 46°F (2°C - 8°C). LANTUS (insulin glargine [rdna origin] injection) should not be stored in the freezer and it should not be allowed to freeze. Discard if it has been frozen.

Open (In-Use) Vial

Opened vials, whether or not refrigerated, must be used within 28 days after the first use. They must be discarded if not used within 28 days. If refrigeration is not possible, the open vial can be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature is not greater than 86°F (30°C). Open (In-Use) Cartridge system:

The opened (in-use) cartridge system in OptiClik® should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in- use) cartridge system in OptiClik® kept at room temperature must be discarded after 28 days. Do not store OptiClik® , with or without cartridge system, in a refrigerator at any time.

Open (In-Use) SoloStar® disposable insulin device

The opened (in-use) SoloStar® should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) SoloStar ® kept at room temperature must be discarded after 28 days.

LANTUS (insulin glargine [rdna origin] injection) should not be stored in the freezer and it should not be allowed to freeze. Discard if it has been frozen.

These storage conditions are summarized in the following table:

  Not in-use
(unopened)
Refrigerated
Not in-use
(unopened)
Room Temperature
In-use
(opened)
(See Temperature Below)
10 mL Vial Until expiration date 28 days 28 daysRefrigerated or room temperature
3 mL Cartridge system Until expiration date 28 days 28 daysRefrigerated or room temperature
3 mL Cartridge system inserted into OptiClik®     28 daysRoom temperature only (Do not refrigerate)
3 mL SoloStar® disposable insulin device Until expiration date 28 days 28 daysRoom temperature only (Do not refrigerate)

Rev. March 2007. Sanofi-aventis U.S. LLC Bridgewater, NJ 08807. Country of Origin: Germany. www.lantus (insulin glargine [rdna origin] injection) .com. OptiClik® and SoloStar® are a registered trademark of sanofi-aventis U.S. LLC. FDA Rev date: 4/25/2007

Last reviewed on RxList: 1/14/2008
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

The adverse events commonly associated with LANTUS (insulin glargine [rdna origin] injection) include the following:

Body as a whole: allergic reactions (see PRECAUTIONS).

Skin and appendages: injection site reaction, lipodystrophy, pruritus, rash (see PRECAUTIONS).

Other: hypoglycemia (see WARNINGS and PRECAUTIONS).

In clinical studies in adult patients, there was a higher incidence of treatment-emergent injection site pain in LANTUS (insulin glargine [rdna origin] injection) -treated patients (2.7%) compared to NPH insulin-treated patients (0.7%).

The reports of pain at the injection site were usually mild and did not result in discontinuation of therapy. Other treatment-emergent injection site reactions occurred at similar incidences with both insulin glargine and NPH human insulin.

Retinopathy was evaluated in the clinical studies by means of retinal adverse events reported and fundus photography. The numbers of retinal adverse events reported for LANTUS (insulin glargine [rdna origin] injection) and NPH treatment groups were similar for patients with type 1 and type 2 diabetes. Progression of retinopathy was investigated by fundus photography using a grading protocol derived from the

Early Treatment Diabetic Retinopathy Study (ETDRS). In one clinical study involving patients with type 2 diabetes, a difference in the number of subjects with ≥ 3-step progression in ETDRS scale over a 6-month period was noted by fundus photography (7.5% in LANTUS (insulin glargine [rdna origin] injection) group versus 2.7% in NPH treated group). The overall relevance of this isolated finding cannot be determined due to the small number of patients involved, the short follow-up period, and the fact that this finding was not observed in other clinical studies.

Read the Lantus (insulin glargine [rdna origin] injection) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

A number of substances affect glucose metabolism and may require insulin dose adjustment and particularly close monitoring.

The following are examples of substances that may increase the blood-glucose-lowering effect and susceptibility to hypoglycemia: oral antidiabetes products, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAO inhibitors, propoxyphene, salicylates, somatostatin analog (e.g., octreotide), sulfonamide antibiotics.

The following are examples of substances that may reduce the blood-glucose-lowering effect of insulin: corticosteroids, danazol, diuretics, sympathomimetic agents (e.g., epinephrine, albuterol, terbutaline), isoniazid, phenothiazine derivatives, somatropin, thyroid hormones, estrogens, progestogens (e.g., in oral contraceptives), protease inhibitors and atypical antipsychotic medications (e.g. olanzapine and clozapine).

Beta-blockers, clonidine, lithium salts, and alcohol may either potentiate or weaken the blood- glucose-lowering effect of insulin. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia.

In addition, under the influence of sympatholytic medicinal products such as beta-blockers, clonidine, guanethidine, and reserpine, the signs of hypoglycemia may be reduced or absent.

Last reviewed on RxList: 1/14/2008
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Hypoglycemia is the most common adverse effect of insulin, including LANTUS (insulin glargine [rdna origin] injection) . As with all insulins, the timing of hypoglycemia may differ among various insulin formulations. Glucose monitoring is recommended for all patients with diabetes.

Any change of insulin should be made cautiously and only under medical supervision. Changes in insulin strength, timing of dosing, manufacturer, type (e.g., regular, NPH, or insulin analogs), species (animal, human), or method of manufacture (recombinant DNA versus animal-source insulin) may result in the need for a change in dosage. Concomitant oral antidiabetes treatment may need to be adjusted.

PRECAUTIONS

General

LANTUS (insulin glargine [rdna origin] injection) is not intended for intravenous administration. The prolonged duration of activity of insulin glargine is dependent on injection into subcutaneous tissue. Intravenous administration of the usual subcutaneous dose could result in severe hypoglycemia.

LANTUS (insulin glargine [rdna origin] injection) must NOT be diluted or mixed with any other insulin or solution. If LANTUS (insulin glargine [rdna origin] injection) is diluted or mixed, the solution may become cloudy, and the pharmacokinetic/pharmacodynamic profile (e.g., onset of action, time to peak effect) of LANTUS (insulin glargine [rdna origin] injection) and/or the mixed insulin may be altered in an unpredictable manner. When LANTUS (insulin glargine [rdna origin] injection) and regular human insulin were mixed immediately before injection in dogs, a delayed onset of action and time to maximum effect for regular human insulin was observed. The total bioavailability of the mixture was also slightly decreased compared to separate injections of LANTUS (insulin glargine [rdna origin] injection) and regular human insulin. The relevance of these observations in dogs to humans is not known.

As with all insulin preparations, the time course of LANTUS (insulin glargine [rdna origin] injection) action may vary in different individuals or at different times in the same individual and the rate of absorption is dependent on blood supply, temperature, and physical activity.

Insulin may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.

Hypoglycemia

As with all insulin preparations, hypoglycemic reactions may be associated with the administration of LANTUS (insulin glargine [rdna origin] injection) . Hypoglycemia is the most common adverse effect of insulins. Early warning symptoms of hypoglycemia may be different or less pronounced under certain conditions, such as long duration of diabetes, diabetes nerve disease, use of medications such as beta-blockers, or intensified diabetes control (see PRECAUTIONS: DRUG INTERACTIONS). Such situations may result in severe hypoglycemia (and, possibly, loss of consciousness) prior to patients' awareness of hypoglycemia.

The time of occurrence of hypoglycemia depends on the action profile of the insulins used and may, therefore, change when the treatment regimen or timing of dosing is changed. Patients being switched from twice daily NPH insulin to once-daily LANTUS (insulin glargine [rdna origin] injection) should have their initial LANTUS (insulin glargine [rdna origin] injection) dose reduced by 20% from the previous total daily NPH dose to reduce the risk of hypoglycemia (see DOSAGE AND ADMINISTRATION, Changeover to LANTUS (insulin glargine [rdna origin] injection) ). The prolonged effect of subcutaneous LANTUS (insulin glargine [rdna origin] injection) may delay recovery from hypoglycemia. In a clinical study, symptoms of hypoglycemia or counterregulatory hormone responses were similar after intravenous insulin glargine and regular human insulin both in healthy subjects and patients with type 1 diabetes.

Renal Impairment

Although studies have not been performed in patients with diabetes and renal impairment, LANTUS (insulin glargine [rdna origin] injection) requirements may be diminished because of reduced insulin metabolism, similar to observations found with other insulins (see CLINICAL PHARMACOLOGY, Special Populations).

Hepatic Impairment

Although studies have not been performed in patients with diabetes and hepatic impairment, LANTUS (insulin glargine [rdna origin] injection) requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism, similar to observations found with other insulins (see CLINICAL PHARMACOLOGY, Special Populations).

Injection Site and Allergic Reactions

As with any insulin therapy, lipodystrophy may occur at the injection site and delay insulin absorption. Other injection site reactions with insulin therapy include redness, pain, itching, hives, swelling, and inflammation. Continuous rotation of the injection site within a given area may help to reduce or prevent these reactions. Most minor reactions to insulins usually resolve in a few days to a few weeks.

Reports of injection site pain were more frequent with LANTUS (insulin glargine [rdna origin] injection) than NPH human insulin (2.7% insulin glargine versus 0.7% NPH). The reports of pain at the injection site were usually mild and did not result in discontinuation of therapy.

Immediate-type allergic reactions are rare. Such reactions to insulin (including insulin glargine) or the excipients may, for example, be associated with generalized skin reactions, angioedema, bronchospasm, hypotension, or shock and may be life threatening.

Intercurrent Conditions

Insulin requirements may be altered during intercurrent conditions such as illness, emotional disturbances, or stress.

Information for Patients

LANTUS (insulin glargine [rdna origin] injection) must only be used if the solution is clear and colorless with no particles visible (see DOSAGE AND ADMINISTRATION, Preparation and Handling).

Patients must be advised that LANTUS (insulin glargine [rdna origin] injection) must NOT be diluted or mixed with any other insulin or solution (see PRECAUTIONS, General).

Patients should be instructed on self-management procedures including glucose monitoring, proper injection technique, and hypoglycemia and hyperglycemia management. Patients must be instructed on handling of special situations such as intercurrent conditions (illness, stress, or emotional disturbances), an inadequate or skipped insulin dose, inadvertent administration of an increased insulin dose, inadequate food intake, or skipped meals. Refer patients to the LANTUS "Patient Information" circular for additional information.

As with all patients who have diabetes, the ability to concentrate and/or react may be impaired as a result of hypoglycemia or hyperglycemia.

Patients with diabetes should be advised to inform their health care professional if they are pregnant or are contemplating pregnancy.

Carcinogenesis, Mutagenesis, Impairment of Fertility

In mice and rats, standard two-year carcinogenicity studies with insulin glargine were performed at doses up to 0.455 mg/kg, which is for the rat approximately 10 times and for the mouse approximately 5 times the recommended human subcutaneous starting dose of 10 IU (0.008 mg/kg/day), based on mg/m2. The findings in female mice were not conclusive due to excessive mortality in all dose groups during the study. Histiocytomas were found at injection sites in male rats (statistically significant) and male mice (not statistically significant) in acid vehicle containing groups. These tumors were not found in female animals, in saline control, or insulin comparator groups using a different vehicle. The relevance of these findings to humans is unknown.

Insulin glargine was not mutagenic in tests for detection of gene mutations in bacteria and mammalian cells (Ames- and HGPRT-test) and in tests for detection of chromosomal aberrations (cytogenetics in vitro in V79 cells and in vivo in Chinese hamsters).

In a combined fertility and prenatal and postnatal study in male and female rats at subcutaneous doses up to 0.36 mg/kg/day, which is approximately 7 times the recommended human subcutaneous starting dose of 10 IU (0.008 mg/kg/day), based on mg/m2, maternal toxicity due to dose-dependent hypoglycemia, including some deaths, was observed. Consequently, a reduction of the rearing rate occurred in the high-dose group only. Similar effects were observed with NPH human insulin.

Pregnancy

Teratogenic Effects: Pregnancy Category C. Subcutaneous reproduction and teratology studies have been performed with insulin glargine and regular human insulin in rats and Himalayan rabbits. The drug was given to female rats before mating, during mating, and throughout pregnancy at doses up to 0.36 mg/kg/day, which is approximately 7 times the recommended human subcutaneous starting dose of 10 IU (0.008 mg/kg/day), based on mg/m2. In rabbits, doses of 0.072 mg/kg/day, which is approximately 2 times the recommended human subcutaneous starting dose of 10 IU (0.008 mg/kg/day), based on mg/m2, were administered during organogenesis. The effects of insulin glargine did not generally differ from those observed with regular human insulin in rats or rabbits. However, in rabbits, five fetuses from two litters of the high-dose group exhibited dilation of the cerebral ventricles. Fertility and early embryonic development appeared normal.

There are no well-controlled clinical studies of the use of insulin glargine in pregnant women. It is essential for patients with diabetes or a history of gestational diabetes to maintain good metabolic control before conception and throughout pregnancy. Insulin requirements may decrease during the first trimester, generally increase during the second and third trimesters, and rapidly decline after delivery. Careful monitoring of glucose control is essential in such patients. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

It is unknown whether insulin glargine is excreted in significant amounts in human milk. Many drugs, including human insulin, are excreted in human milk. For this reason, caution should be exercised when LANTUS (insulin glargine [rdna origin] injection) is administered to a nursing woman. Lactating women may require adjustments in insulin dose and diet.

Pediatric Use

Safety and effectiveness of LANTUS (insulin glargine [rdna origin] injection) have been established in the age group 6 to 15 years with type 1 diabetes.

Geriatric Use

In controlled clinical studies comparing insulin glargine to NPH human insulin, 593 of 3890 patients with type 1 and type 2 diabetes were 65 years and older. The only difference in safety or effectiveness in this subpopulation compared to the entire study population was an expected higher incidence of cardiovascular events in both insulin glargine and NPH human insulin- treated patients.

In elderly patients with diabetes, the initial dosing, dose increments, and maintenance dosage should be conservative to avoid hypoglycemic reactions. Hypoglycemia may be difficult to recognize in the elderly (see PRECAUTIONS, Hypoglycemia).

Last reviewed on RxList: 1/14/2008
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

An excess of insulin relative to food intake, energy expenditure, or both may lead to severe and sometimes long-term and life-threatening hypoglycemia. Mild episodes of hypoglycemia can usually be treated with oral carbohydrates. Adjustments in drug dosage, meal patterns, or exercise may be needed.

More severe episodes with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. After apparent clinical recovery from hypoglycemia, continued observation and additional carbohydrate intake may be necessary to avoid reoccurrence of hypoglycemia.

CONTRAINDICATIONS

LANTUS (insulin glargine [rdna origin] injection) is contraindicated in patients hypersensitive to insulin glargine or the excipients.

Last reviewed on RxList: 1/14/2008
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Mechanism of Action

The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism. Insulin and its analogs lower blood glucose levels by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis in the adipocyte, inhibits proteolysis, and enhances protein synthesis.

Pharmacodynamics

Insulin glargine is a human insulin analog that has been designed to have low aqueous solubility at neutral pH. At pH 4, as in the LANTUS (insulin glargine [rdna origin] injection) injection solution, it is completely soluble. After injection into the subcutaneous tissue, the acidic solution is neutralized, leading to formation of microprecipitates from which small amounts of insulin glargine are slowly released, resulting in a relatively constant concentration/time profile over 24 hours with no pronounced peak. This profile allows once-daily dosing as a patient's basal insulin.

In clinical studies, the glucose-lowering effect on a molar basis (i.e., when given at the same doses) of intravenous insulin glargine is approximately the same as human insulin. In euglycemic clamp studies in healthy subjects or in patients with type 1 diabetes, the onset of action of subcutaneous insulin glargine was slower than NPH human insulin. The effect profile of insulin glargine was relatively constant with no pronounced peak and the duration of its effect was prolonged compared to NPH human insulin. Figure 1 shows results from a study in patients with type 1 diabetes conducted for a maximum of 24 hours after the injection. The median time between injection and the end of pharmacological effect was 14.5 hours (range: 9.5 to 19.3 hours) for NPH human insulin, and 24 hours (range: 10.8 to > 24.0 hours) (24 hours was the end of the observation period) for insulin glargine.

Figure 1. Activity Profile in Patients with Type 1 Diabetes

Activity Profile in Patients with Type 1 Diabetes - illustration

* Determined as amount of glucose infused to maintain constant plasma glucose levels (hourly mean values); indicative of insulin activity.
Between-patient variability (CV, coefficient of variation); insulin glargine, 84% and NPH, 78%. The longer duration of action (up to 24 hours) of LANTUS (insulin glargine [rdna origin] injection) is directly related to its slower rate of absorption and supports once-daily subcutaneous administration. The time course of action of insulins, including LANTUS (insulin glargine [rdna origin] injection) , may vary between individuals and/or within the same individual.

Pharmacokinetics

Absorption and Bioavailability. After subcutaneous injection of insulin glargine in healthy subjects and in patients with diabetes, the insulin serum concentrations indicated a slower, more prolonged absorption and a relatively constant concentration/time profile over 24 hours with no pronounced peak in comparison to NPH human insulin. Serum insulin concentrations were thus consistent with the time profile of the pharmacodynamic activity of insulin glargine. After subcutaneous injection of 0.3 IU/kg insulin glargine in patients with type 1 diabetes, a relatively constant concentration/time profile has been demonstrated. The duration of action after abdominal, deltoid, or thigh subcutaneous administration was similar.

Metabolism. A metabolism study in humans indicates that insulin glargine is partly metabolized at the carboxyl terminus of the B chain in the subcutaneous depot to form two active metabolites with in vitro activity similar to that of insulin, M1 (21A-Gly-insulin) and M2 (21A-Gly-des-30B- Thr-insulin). Unchanged drug and these degradation products are also present in the circulation.

Special Populations

Age, Race, and Gender. Information on the effect of age, race, and gender on the pharmacokinetics of LANTUS (insulin glargine [rdna origin] injection) is not available. However, in controlled clinical trials in adults (n=3890) and a controlled clinical trial in pediatric patients (n=349), subgroup analyses based on age, race, and gender did not show differences in safety and efficacy between insulin glargine and NPH human insulin.

Smoking. The effect of smoking on the pharmacokinetics/pharmacodynamics of LANTUS (insulin glargine [rdna origin] injection) has not been studied.

Pregnancy. The effect of pregnancy on the pharmacokinetics and pharmacodynamics of LANTUS has not been studied (see PRECAUTIONS, Pregnancy).

Obesity. In controlled clinical trials, which included patients with Body Mass Index (BMI) up to and including 49.6 kg/m2, subgroup analyses based on BMI did not show any differences in safety and efficacy between insulin glargine and NPH human insulin.

Renal Impairment. The effect of renal impairment on the pharmacokinetics of LANTUS (insulin glargine [rdna origin] injection) has not been studied. However, some studies with human insulin have shown increased circulating levels of insulin in patients with renal failure. Careful glucose monitoring and dose adjustments of insulin, including LANTUS (insulin glargine [rdna origin] injection) , may be necessary in patients with renal dysfunction (see PRECAUTIONS, Renal Impairment).

Hepatic Impairment. The effect of hepatic impairment on the pharmacokinetics of LANTUS (insulin glargine [rdna origin] injection) has not been studied. However, some studies with human insulin have shown increased circulating levels of insulin in patients with liver failure. Careful glucose monitoring and dose adjustments of insulin, including LANTUS (insulin glargine [rdna origin] injection) , may be necessary in patients with hepatic dysfunction (see PRECAUTIONS, Hepatic Impairment).

Clinical Studies

The safety and effectiveness of insulin glargine given once-daily at bedtime was compared to that of once-daily and twice-daily NPH human insulin in open-label, randomized, active-control, parallel studies of 2327 adult patients and 349 pediatric patients with type 1 diabetes mellitus and 1563 adult patients with type 2 diabetes mellitus (see Tables 1-3). In general, the reduction in glycated hemoglobin (HbA1c) with LANTUS (insulin glargine [rdna origin] injection) was similar to that with NPH human insulin. The overall rates of hypoglycemia did not differ between patients with diabetes treated to LANTUS (insulin glargine [rdna origin] injection) compared with NPH human insulin.

Type 1 Diabetes-Adult (see Table 1). In two large, randomized, controlled clinical studies (Studies A and B), patients with type 1 diabetes (Study A; n=585, Study B; n=534) were randomized to basal-bolus treatment with LANTUS (insulin glargine [rdna origin] injection) once daily at bedtime or to NPH human insulin once or twice daily and treated for 28 weeks. Regular human insulin was administered before each meal. LANTUS (insulin glargine [rdna origin] injection) was administered at bedtime. NPH human insulin was administered once daily at bedtime or in the morning and at bedtime when used twice daily. In one large, randomized, controlled clinical study (Study C), patients with type 1 diabetes (n=619) were treated for 16 weeks with a basal-bolus insulin regimen where insulin lispro was used before each meal. LANTUS (insulin glargine [rdna origin] injection) was administered once daily at bedtime and NPH human insulin was administered once or twice daily. In these studies, LANTUS (insulin glargine [rdna origin] injection) and NPH human insulin had a similar effect on glycohemoglobin with a similar overall rate of hypoglycemia.

Table 1: Type 1 Diabetes Mellitus-Adult


Treatment duration Treatment in combination with Study A
28 weeks
Regular insulin
Study B
28 weeks
Regular insulin
Study C
16 weeks
Insulin lispro
  LANTUS NPH LANTUS NPH LANTUS NPH
Number of subjects treated 292 293 264 270 310 309
HbA1c
  Endstudy mean 8.13 8.07 7.55 7.49 7.53 7.60
  Adj. mean change from baseline +0.21 +0.10 -0.16 -0.21 -0.07 -0.08
  LANTUS - NPH +0.11 +0.05 +0.01
  95% CI for Treatment difference (-0.03; +0.24) (-0.08; +0.19) (-0.11; +0.13)
Basal insulin dose
  Endstudy mean 19.2 22.8 24.8 31.3 23.9 29.2
  Mean change from baseline -1.7 -0.3 -4.1 +1.8 -4.5 +0.9
Total insulin dose
  Endstudy mean 46.7 51.7 50.3 54.8 47.4 50.7
  Mean change from baseline -1.1 -0.1 +0.3 +3.7 -2.9 +0.3
Fasting blood glucose (mg/dL)
  Endstudy mean 146.3 150.8 147.8 154.4 144.4 161.3
  Adj. mean change from baseline -21.1 -16.0 -20.2 -16.9 -29.3 -11.9

Type 1 Diabetes-Pediatric (see Table 2). In a randomized, controlled clinical study (Study D), pediatric patients (age range 6 to 15 years) with type 1 diabetes (n=349) were treated for 28 weeks with a basal-bolus insulin regimen where regular human insulin was used before each meal. LANTUS (insulin glargine [rdna origin] injection) was administered once daily at bedtime and NPH human insulin was administered once or twice daily. Similar effects on glycohemoglobin and the incidence of hypoglycemia were observed in both treatment groups.

Table 2: Type 1 Diabetes Mellitus-Pediatric

Study D
Treatment duration
Treatment in combination with
28 weeks
Regular insulin
  LANTUS NPH
Number of subjects treated 174 175
HbA1c
  Endstudy mean 8.91 9.18
  Adj. mean change from baseline +0.28 +0.27
  LANTUS - NPH +0.01
  95% CI for Treatment difference (-0.24; +0.26)
Basal insulin dose
  Endstudy mean 18.2 21.1
  Mean change from baseline -1.3 +2.4
Total insulin dose
  Endstudy mean 45.0 46.0
  Mean change from baseline +1.9 +3.4
Fasting blood glucose (mg/dL)
  Endstudy mean 171.9 182.7
  Adj. mean change from baseline -23.2 -12.2

Type 2 Diabetes-Adult (see Table 3). In a large, randomized, controlled clinical study (Study E) (n=570), LANTUS (insulin glargine [rdna origin] injection) was evaluated for 52 weeks as part of a regimen of combination therapy with insulin and oral antidiabetes agents (a sulfonylurea, metformin, acarbose, or combinations of these drugs). LANTUS (insulin glargine [rdna origin] injection) administered once daily at bedtime was as effective as NPH human insulin administered once daily at bedtime in reducing glycohemoglobin and fasting glucose. There was a low rate of hypoglycemia that was similar in LANTUS (insulin glargine [rdna origin] injection) and NPH human insulin treated patients. In a large, randomized, controlled clinical study (Study F), in patients with type 2 diabetes not using oral antidiabetes agents (n=518), a basal-bolus regimen of LANTUS (insulin glargine [rdna origin] injection) once daily at bedtime or NPH human insulin administered once or twice daily was evaluated for 28 weeks. Regular human insulin was used before meals as needed. LANTUS (insulin glargine [rdna origin] injection) had similar effectiveness as either once- or twice-daily NPH human insulin in reducing glycohemoglobin and fasting glucose with a similar incidence of hypoglycemia.

Table 3: Type 2 Diabetes Mellitus-Adult

  Study E Study F
Treatment duration
Treatment in combination with
52 weeks
Oral agents
28 weeks
Regular insulin
  LANTUS NPH LANTUS NPH
Number of subjects treated 289 281 259 259
HbA1c
  Endstudy mean 8.51 8.47 8.14 7.96
  Adj. mean change from baseline -0.46 -0.38 -0.41 -0.59
  LANTUS - NPH -0.08 +0.17
  95% CI for Treatment difference (-0.28; +0.12) (-0.00; +0.35)
Basal insulin dose
  Endstudy mean 25.9 23.6 42.9 52.5
  Mean change from baseline +11.5 +9.0 -1.2 +7.0
Total insulin dose
  Endstudy mean 25.9 23.6 74.3 80.0
  Mean change from baseline +11.5 +9.0 +10.0 +13.1
Fasting blood glucose (mg/dL)
  Endstudy mean 126.9 129.4 141.5 144.5
  Adj. mean change from baseline -49.0 -46.3 -23.8 -21.6

LANTUS (insulin glargine [rdna origin] injection) Flexible Daily Dosing

The safety and efficacy of LANTUS (insulin glargine [rdna origin] injection) administered pre-breakfast, pre-dinner, or at bedtime were evaluated in a large, randomized, controlled clinical study, in patients with type 1 diabetes (study G, n=378). Patients were also treated with insulin lispro at mealtime. LANTUS (insulin glargine [rdna origin] injection) administered at different times of the day resulted in similar reductions in glycated hemoglobin compared to that with bedtime administration (see Table 4). In these patients, data are available from 8-point home glucose monitoring. The maximum mean blood glucose level was observed just prior to injection of LANTUS (insulin glargine [rdna origin] injection) regardless of time of administration, i.e. pre-breakfast, pre-dinner, or bedtime.

In this study, 5% of patients in the LANTUS (insulin glargine [rdna origin] injection) -breakfast arm discontinued treatment because of lack of efficacy. No patients in the other two arms discontinued for this reason. Routine monitoring during this trial revealed the following mean changes in systolic blood pressure: pre- breakfast group, 1.9 mm Hg; pre-dinner group, 0.7 mm Hg; pre-bedtime group, -2.0 mm Hg. The safety and efficacy of LANTUS (insulin glargine [rdna origin] injection) administered pre-breakfast or at bedtime were also evaluated in a large, randomized, active-controlled clinical study (Study H, n=697) in type 2 diabetes patients no longer adequately controlled on oral agent therapy. All patients in this study also received AMARYL® (glimepiride) 3 mg daily. LANTUS (insulin glargine [rdna origin] injection) given before breakfast was at least as effective in lowering glycated hemoglobin A1c (HbA1c) as LANTUS (insulin glargine [rdna origin] injection) given at bedtime or NPH human insulin given at bedtime (see Table 4).

Table 4: Flexible LANTUS (insulin glargine [rdna origin] injection) Daily Dosing in Type 1 (Study G) and Type 2 (Study H) Diabetes Mellitus

Treatment duration Treatment in combination with: Study G 24 weeks Study H 24 weeks
Insulin lispro AMARYL® (glimepiride)
  LANTUS
Breakfast
LANTUS
Dinner
LANTUS
Bedtime
LANTUS
Breakfast
LANTUS
Bedtime
NPH
Bedtime
Number of subjects treated* 112 124 128 234 226 227
HbA1c
  Baseline mean 7.56 7.53 7.61 9.13 9.07 9.09
  Endstudy mean 7.39 7.42 7.57 7.87 8.12 8.27
  Mean change from baseline -0.17 -0.11 -0.04 -1.26 -0.95 -0.83
Basal insulin dose (IU)
  Endstudy mean 27.3 24.6 22.8 40.4 38.5 36.8
  Mean change from baseline 5.0 1.8 1.5      
Total insulin dose (IU)       NA** NA NA
  Endstudy mean 53.3 54.7 51.5      
  Mean change from baseline 1.6 3.0 2.3      
*Intent to treat
**Not applicable

Last reviewed on RxList: 1/14/2008
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

LANTUS® (insulin glargine [rdna origin] injection) SOLOSTAR® 3 mL disposable insulin delivery device (300 units per device) 100 units per mL (U-100) (insulin glargine [recombinant DNA origin] injection)

  • What is the most important information I should know about LANTUS (insulin glargine [rdna origin] injection) ?
  • What is LANTUS (insulin glargine [rdna origin] injection) ?
  • Who should NOT take LANTUS (insulin glargine [rdna origin] injection) ?
  • How should I use LANTUS (insulin glargine [rdna origin] injection) ?
  • Mixing with LANTUS (insulin glargine [rdna origin] injection)
  • Instructions for Use
  • What can affect how much insulin I need?
  • What are the possible side effects of LANTUS (insulin glargine [rdna origin] injection) and other insulins?
  • How should I store LANTUS (insulin glargine [rdna origin] injection) ?
  • General Information about LANTUS (insulin glargine [rdna origin] injection)

Read this "Patient Information" that comes with LANTUS (insulin glargine [rdna origin] injection) (LAN-tus) before you start using it and each time you get a refill because there may be new information. This leaflet does not take the place of talking with your healthcare provider about your condition or treatment. If you have questions about LANTUS (insulin glargine [rdna origin] injection) or about diabetes, talk with your healthcare provider.

What is the most important information I should know about LANTUS (insulin glargine [rdna origin] injection) ?

  • Do not change the insulin you are using without talking to your healthcare provider. Any change of insulin should be made cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type (for example: Regular, NPH, analogs), species (beef, pork, beef-pork, human) or method of manufacture (recombinant DNA versus animal-source insulin) may need a change in the dose. This dose change may be needed right away or later on during the first several weeks or months on the new insulin. Doses of oral anti-diabetic medicines may also need to change, if your insulin is changed.
  • You must test your blood sugar levels while using an insulin, such as LANTUS (insulin glargine [rdna origin] injection) . Your healthcare provider will tell you how often you should test your blood sugar level, and what to do if it is high or low.
  • Do NOT dilute or mix LANTUS (insulin glargine [rdna origin] injection) with any other insulin or solution. It will not work and you may lose blood sugar control, which could be serious.
  • LANTUS (insulin glargine [rdna origin] injection) comes as U-100 insulin and contains 100 units of LANTUS (insulin glargine [rdna origin] injection) per milliliter (mL). One milliliter of U-100 insulin contains 100 units of insulin. (1 mL = 1 cc).

What is Diabetes?

  • Your body needs insulin to turn sugar (glucose) into energy. If your body does not make enough insulin, you need to take more insulin so you will not have too much sugar in your blood.
  • Insulin injections are important in keeping your diabetes under control. But the way you live, your diet, careful checking of your blood sugar levels, exercise, and planned physical activity, all work with your insulin to help you control your diabetes.

What is LANTUS (insulin glargine [rdna origin] injection) ?

  • LANTUS (insulin glargine [rdna origin] injection) (insulin glargine [recombinant DNA origin]) is a long-acting insulin. . Because Lantus (insulin glargine [rdna origin] injection) is made by recombinant DNA technology (rDNA) and is chemically different from the insulin made by the human body, it is called an insulin analog. LANTUS (insulin glargine [rdna origin] injection) is used to treat patients with diabetes for the control of high blood sugar. It is used once a day to lower blood glucose.
  • LANTUS (insulin glargine [rdna origin] injection) is a clear, colorless, sterile solution for injection under the skin (subcutaneously).
  • The active ingredient in LANTUS (insulin glargine [rdna origin] injection) is insulin glargine. The concentration of insulin glargine is 100 units per milliliter (mL), or U-100. LANTUS (insulin glargine [rdna origin] injection) also contains zinc, metacresol, glycerol, and water for injection as inactive ingredients. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH.
  • You need a prescription to get LANTUS (insulin glargine [rdna origin] injection) . Always be sure you receive the right insulin from the pharmacy.

Who should NOT take LANTUS (insulin glargine [rdna origin] injection) ?

Do not take LANTUS (insulin glargine [rdna origin] injection) if you are allergic to insulin glargine or any of the inactive ingredients in LANTUS (insulin glargine [rdna origin] injection) . Check with your healthcare provider if you are not sure.

  • Before starting LANTUS (insulin glargine [rdna origin] injection) , tell your healthcare provider about all your medical conditions including if you:
    • have liver or kidney problems. Your dose may need to be adjusted.
    • are pregnant or plan to become pregnant. It is not known if LANTUS (insulin glargine [rdna origin] injection) may harm your unborn baby. It is very important to maintain control of your blood sugar levels during pregnancy. Your healthcare provider will decide which insulin is best for you during your pregnancy.
    • are breast-feeding or plan to breast-feed. It is not known whether LANTUS (insulin glargine [rdna origin] injection) passes into your milk. Many medicines, including insulin, pass into human milk, and could affect your baby. Talk to your healthcare provider about the best way to feed your baby.
    • are taking any other medicines including prescription and non-prescription medicines, vitamins and herbal supplements.

How should I use LANTUS (insulin glargine [rdna origin] injection) ?

See the "Instructions for SoloStar® Use" section for additional information.

  • Follow the instructions given by your healthcare provider about the type or types of insulin you are using. Do not make any changes with your insulin unless you have talked to your healthcare provider. Your insulin needs may change because of illness, stress, other medicines, or changes in diet or activity level. Talk to your healthcare provider about how to adjust your insulin dose.
  • You may take LANTUS (insulin glargine [rdna origin] injection) at any time during the day but you must take it at the same time every day.
  • Only use LANTUS (insulin glargine [rdna origin] injection) that is clear and colorless. If your LANTUS (insulin glargine [rdna origin] injection) is cloudy or slightly colored, return it to your pharmacy for a replacement.
  • Follow your healthcare provider's instructions for testing your blood sugar.
  • Inject LANTUS (insulin glargine [rdna origin] injection) under your skin (subcutaneously) in your upper arm, abdomen (stomach area), or thigh (upper leg). Never inject it into a vein or muscle.
  • Change (rotate) injection sites within the same body area.
  • NEEDLES AND SOLOSTAR® MUST NOT BE SHARED.
  • Disposable needles should be used only once. Used needle should be placed in sharps containers (such as red biohazard containers), hard plastic containers (such as detergent bottles), or metal containers (such as an empty coffee can). Such containers should be sealed and disposed of properly.

Mixing with LANTUS (insulin glargine [rdna origin] injection)

  • Do NOT dilute or mix LANTUS (insulin glargine [rdna origin] injection) with any other insulin or solution. It will not work as intended and you may lose blood sugar control, which could be serious.

Instructions for SoloStar® Use

It is important to read, understand, and follow the step-by-step instructions in the "SoloStar® Instruction Leaflet" before using SoloStar® disposable insulin Pen. Failure to follow the instructions may result in getting too much or too little insulin. If you have lost your leaflet or have a question, go to www.lantus (insulin glargine [rdna origin] injection) .com or call 1-800-633-1610.

The following general notes should be taken into consideration before injecting Lantus (insulin glargine [rdna origin] injection) :

  • Always wash your hands before handling the SoloStar® disposable insulin Pen.
  • Always attach a new needle before use. BD Ultra-Fine™ needles† are compatible with SoloStar. These are sold separately and are manufactured by BD.
  • Always perform the safety test before use.
  • Check the insulin solution in the pen to make sure it is clear, colorless, and free of particles. If it is not, throw it away.
  • Do NOT mix or dilute LANTUS (insulin glargine [rdna origin] injection) with any other insulin or solution. LANTUS (insulin glargine [rdna origin] injection) will not work if it is mixed or diluted and you may lose blood sugar control, which could be serious.
  • Decide on an injection area - either upper arm, thigh, or abdomen. Do not use the same injection site as your last injection.
  • After injecting LANTUS (insulin glargine [rdna origin] injection) , leave the needle in the skin for an additional 10 seconds. Then pull the needle straight out. Gently press on the spot where you injected yourself for a few seconds. Do not rub the area.
  • Do not drop the SoloStar® disposable insulin Pen.

If your blood glucose reading is high or low, tell your healthcare provider so the dose can be adjusted.

What can affect how much insulin I need?

Illness. Illness may change how much insulin you need. It is a good idea to think ahead and make a "sick day" plan with your healthcare provider in advance so you will be ready when this happens. Be sure to test your blood sugar more often and call your healthcare provider if you are sick.

Medicines. Many medicines can affect your insulin needs. Other medicines, including prescription and non-prescription medicines, vitamins, and herbal supplements, can change the way insulin works. You may need a different dose of insulin when you are taking certain other medicines. Know all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. You may want to keep a list of the medicines you take. You can show this list to your healthcare provider and pharmacists anytime you get a new medicine or refill. Your healthcare provider will tell you if your insulin dose needs to be changed.

Meals. The amount of food you eat can affect your insulin needs. If you eat less food, skip meals, or eat more food than usual, you may need a different dose of insulin. Talk to your healthcare provider if you change your diet so that you know how to adjust your LANTUS (insulin glargine [rdna origin] injection) and other insulin doses.

Alcohol. Alcohol, including beer and wine, may affect the way LANTUS (insulin glargine [rdna origin] injection) works and affect your blood sugar levels. Talk to your healthcare provider about drinking alcohol.

Exercise or Activity level. Exercise or activity level may change the way your body uses insulin. Check with your healthcare provider before you start an exercise program because your dose may need to be changed.

Travel. If you travel across time zones, talk with your healthcare provider about how to time your injections. When you travel, wear your medical alert identification. Take extra insulin and supplies with you.

Pregnancy or nursing. The effects of LANTUS (insulin glargine [rdna origin] injection) on an unborn child or on a nursing baby are unknown. Therefore, tell your healthcare provider if you planning to have a baby, are pregnant, or nursing a baby. Good control of diabetes is especially important during pregnancy and nursing.

What are the possible side effects of LANTUS (insulin glargine [rdna origin] injection) and other insulins?

Insulins, including LANTUS (insulin glargine [rdna origin] injection) , can cause hypoglycemia (low blood sugar), hyperglycemia (high blood sugar), allergy, and skin reactions.

Hypoglycemia (low blood sugar):

Hypoglycemia is often called an "insulin reaction" or "low blood sugar". It may happen when you do not have enough sugar in your blood. Common causes of hypoglycemia are illness, emotional or physical stress, too much insulin, too little food or missed meals, and too much exercise or activity.

Early warning signs of hypoglycemia may be different, less noticeable or not noticeable at all in some people. That is why it is important to check your blood sugar as you have been advised by your healthcare provider.

Hypoglycemia can happen with:

  • Taking too much insulin. This can happen when too much insulin is injected.
  • Not enough carbohydrate (sugar or starch) intake. This can happen if a meal or snack is missed or delayed.
  • Vomiting or diarrhea that decreases the amount of sugar absorbed by your body.
  • Intake of alcohol.
  • Medicines that affect insulin. Be sure to discuss all your medicines with your healthcare provider. Do not start any new medicines until you know how they may affect your insulin dose.
  • Medical conditions that can affect your blood sugar levels or insulin. These conditions include diseases of the adrenal glands, the pituitary, the thyroid gland, the liver, and the kidney.
  • Too much glucose use by the body. This can happen if you exercise too much or have a fever.
  • Injecting insulin the wrong way or in the wrong injection area.

Hypoglycemia can be mild to severe. Its onset may be rapid. Some patients have few or no warning symptoms, including:

Hypoglycemia may reduce your ability to drive a car or use mechanical equipment and you may risk injury to yourself or others.

Severe hypoglycemia can be dangerous and can cause temporary or permanent harm to your heart or brain. It may cause unconsciousness, seizures, or death.

Symptoms of hypoglycemia may include:

If you have hypoglycemia often or it is hard for you to know if you have the symptoms of hypoglycemia, talk to your healthcare provider.

Mild to moderate hypoglycemia is treated by eating or drinking carbohydrates such as fruit juice, raisins, sugar candies, milk or glucose tablets. Talk to your healthcare provider about the amount of carbohydrates you should eat to treat mild to moderate hypoglycemia.

Severe hypoglycemia may require the help of another person or emergency medical people. A person with hypoglycemia who is unable to take foods or liquids with sugar by mouth, or is unconscious needs medical help fast and will need treatment with a glucagon injection or glucose given intravenously (IV). Without medical help right away, serious reactions or even death could happen.

Hyperglycemia (high blood sugar):

Hyperglycemia happens when you have too much sugar in your blood. Usually, it means there is not enough insulin to break down the food you eat into energy your body can use. Hyperglycemia can be caused by a fever, an infection, stress, eating more than you should, taking less insulin than prescribed, or it can mean your diabetes is getting worse.

Hyperglycemia can happen with:

  • Insufficient (too little) insulin. This can happen from:
    • - injecting too little or no insulin
    • - incorrect storage (freezing, excessive heat)
    • - use after the expiration date.
  • Too much carbohydrate intake. This can happen if you eat larger meals, eat more often, or increase the amount of carbohydrate in your meals.
  • Medicines that affect insulin. Be sure to discuss all your medicines with your healthcare provider. Do not start any new medicines until you know how they may affect your insulin dose.
  • Medical conditions that affect insulin. These medical conditions include fevers, infections, heart attacks, and stress.
  • Injecting insulin the wrong way or in the wrong injection area.

Testing your blood or urine often will let you know if you have hyperglycemia. If your tests are often high, tell your healthcare provider so your dose of insulin can be changed.

Hyperglycemia can be mild or severe. It can progress to diabetic ketoacidosis (DKA) or very high glucose levels (hyperosmolar coma) and result in unconsciousness and death.

Although diabetic ketoacidosis occurs most often in patients with type 1 diabetes,it can also happen in patients with type 2 diabetes who become very sick. Because some patients get few symptoms of hyperglycemia, it is important to check your blood sugar/urine sugar and ketones regularly.

Symptoms of hyperglycemia include:

  • confusion or drowsiness
  • increased thirst
  • decreased appetite, nausea, or vomiting
  • rapid heart rate
  • increased urination and dehydration (too little fluid in your body).

Symptoms of DKA also include:

Severe or continuing hyperglycemia or DKA needs evaluation and treatment right away by your healthcare provider.

Do not use LANTUS (insulin glargine [rdna origin] injection) to treat diabetic ketoacidosis.

Other possible side effects of LANTUS (insulin glargine [rdna origin] injection) include:

Serious allergic reactions

Some times severe, life-threatening allergic reactions can happen with insulin. If you think you are having a severe allergic reaction, get medical help right away. Signs of insulin allergy include:

Reactions at the injection site:

Injecting insulin can cause the following reactions on the skin at the injection site:

  • little depression in the skin (lipoatrophy)
  • skin thickening (lipohypertrophy)
  • red, swelling, itchy skin (injection site reaction).

You can reduce the chance of getting an injection site reaction if you change (rotate) the injection site each time. An injection site reaction should clear up in a few days or a few weeks. If injection site reactions do not go away or keep happening call your healthcare provider.

Tell your healthcare provider if you have any side effects that bother you.

These are not all the side effects of LANTUS (insulin glargine [rdna origin] injection) . Ask your healthcare provider or pharmacist for more information.

How should I store LANTUS (insulin glargine [rdna origin] injection) ?

  • Unopened SoloStar®:
    Store new unopened SoloStar® disposable insulin pen in a refrigerator (not the freezer) between 36°F to 46°F (2°C to 8°C). Do not freeze LANTUS (insulin glargine [rdna origin] injection) . Keep LANTUS (insulin glargine [rdna origin] injection) out of direct heat and light. If a disposable insulin pen has been frozen or overheated, throw it away.
  • Open (In-Use) SoloStar®:
    Once SoloStar® is opened (in-use), SoloStar® should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) SoloStar® kept at room temperature must be discarded after 28 days.

These storage conditions are summarized in the following table:

  Not in-use
(unopened)
Refrigerated
Not in-use
(unopened)
Room Temperature
In-use
(opened) Room Temperature
(Do not refrigerate)
3 mL SoloStar® disposable insulin device Until expiration date 28 days 28 days

  • Do not use SoloStar® with LANTUS (insulin glargine [rdna origin] injection) after the expiration date stamped on the label.
  • Do not use LANTUS (insulin glargine [rdna origin] injection) if it is cloudy, colored, or if you see particles.

General Information about LANTUS (insulin glargine [rdna origin] injection)

  • Use LANTUS (insulin glargine [rdna origin] injection) only to treat your diabetes. Do not give or share LANTUS (insulin glargine [rdna origin] injection) with another person, even if they have diabetes also. It may harm them.
  • This leaflet summarizes the most important information about LANTUS (insulin glargine [rdna origin] injection) . If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about LANTUS (insulin glargine [rdna origin] injection) that is written for healthcare professionals. For more information about LANTUS (insulin glargine [rdna origin] injection) call 1-800-633-1610 or go to website www.lantus (insulin glargine [rdna origin] injection) .com.

ADDITIONAL INFORMATION

DIABETES FORECAST is a national magazine designed especially for patients with diabetes and their families and is available by subscription from the American Diabetes Association (ADA), P.O. Box 363, Mt. Morris, IL 61054-0363, 1-800-DIABETES (1-800-342-2383). You may also visit the ADA website at www.diabetes.org.

Another publication, COUNTDOWN, is available from the Juvenile Diabetes Research Foundation International (JDRF), 120 Wall Street, 19th Floor, New York, New York 10005, 1- 800-JDF-CURE (1-800-533-2873). You may also visit the JDRF website at www.jdf.org.

To get more information about diabetes, check with your healthcare professional or diabetes educator or visit www.DiabetesWatch.com.

Additional information about LANTUS (insulin glargine [rdna origin] injection) can be obtained by calling 1-800-633-1610 or by visiting www.lantus (insulin glargine [rdna origin] injection) .com.

LANTUS® SOLOSTAR®
(insulin glargine [rDNA origin] injection)

Instruction Leaflet

Your healthcare professional has decided that SoloStar® is right for you. Talk with your healthcare professional about proper injection technique before using SoloStar®.

Read these instructions carefully before using your SoloStar®. If you are not able to follow all the instructions completely on your own, use SoloStar® only if you have help from a person who is able to follow the instructions.

Follow these instructions completely each time you use SoloStar® to ensure that you get an accurate dose. If you do not follow these instructions you may get too much or too little insulin, which may affect your blood glucose.

SoloStar® is a disposable pen for the injection of insulin. Each SoloStar® contains in total 300 units of insulin. You can set doses from 1 to 80 units in steps of 1 unit.

Keep this leaflet for future reference.

If you have any questions about Solostar® or about diabetes, ask your healthcare professional, go to www.lantus (insulin glargine [rdna origin] injection) .com or call sanofi aventis at 1-800-633-1610.

SoloStar®  disposable pen for the injection - illustration

Important information for use of SoloStar®:

  • Always attach a new needle before each use.
    BD Ultra-Fine needles are compatible with SoloStar® . These are sold separately and are manufactured by BD. Contact your healthcare professional for further information.
  • Always perform the safety test before each injection.
  • This pen is only for your use. Do not share it with anyone else.
  • If your injection is given by another person, special caution must be taken by this person to avoid accidental needle injury and transmission of infection.
  • Never use SoloStar® if it is damaged or if you are not sure that it is working properly.
  • Always have a spare SoloStar® in case your SoloStar® is lost or damaged.

Storage Instructions

Please check the leaflet for the insulin for complete instructions on how to store SoloStar®.

If your SoloStar® is in cool storage, take it out 1 to 2 hours before you inject to allow it to warm up. Cold insulin is more painful to inject.

Keep SoloStar® out of the reach and sight of children.

Keep your SoloStar® in cool storage (36°F - 46°F [2°C - 8°C]) until first use. Do not allow it to freeze. Do not put it next to the freezer compartment of your refrigerator, or next to a freezer pack.

Once you take your SoloStar® out of cool storage, for use or as a spare, you can use it for up to 28 days. During this time it can be safely kept at room temperature up to 86°F (30°C). Do not use it after this time. SoloStar® in use must not be stored in a refrigerator.

Do not use SoloStar® after the expiration date printed on the label of the pen or on the carton.

Protect SoloStar® from light.

Discard your used SoloStar® as required by your local authorities.

Maintenance

Protect your SoloStar® from dust and dirt.

You can clean the outside of your SoloStar® by wiping it with a damp cloth.

Do not soak, wash or lubricate the pen as this may damage it.

Your SoloStar® is designed to work accurately and safely. It should be handled with care. Avoid situations where SoloStar® might be damaged. If you are concerned that your SoloStar® may be damaged, use a new one.

Step 1. Check the insulin

  1. Check the label on your SoloStar® to make sure you have the correct insulin.. The Lantus® (insulin glargine [rdna origin] injection) SoloStar® is grey with a purple injection button.
  2. Take off the pen cap.
  3. Check the appearance of your insulin. Lantus® (insulin glargine [rdna origin] injection) is a clear insulin. Do not use this SoloStar® if the insulin is cloudy, colored or has particles.

Step 2. Attach the needle

Always use a new sterile needle for each injection. This helps prevent contamination, and potential needle blocks.

  1. Wipe the Rubber Seal with alcohol.
  2. Remove the protective seal from a new needle.
  3. Line up the needle with the pen, and keep it straight as you attach it (screw or push on, depending on the needle type).

Line up the needle with the pen, and keep it straight as you attach it - illustration

  • If the needle is not kept straight while you attach it, it can damage the rubber seal and cause leakage, or break the needle.

If the needle is not kept straight while you attach it, it can damage the rubber seal and cause leakage, or break the needle - illustration

Step 3. Perform a Safety test

Always perform the safety test before each injection.

Performing the safety test ensures that you get an accurate dose by:

  • ensuring that pen and needle work properly
  • removing air bubbles

A. Select a dose of 2 units by turning the dosage selector.

Select a dose of 2 units by turning the dosage selector - illustration

B. Take off the outer needle cap and keep it to remove the used needle after injection. Take off the inner needle cap and discard it.

Take off the outer needle cap and keep it to remove the used needle after injection - illustration

C. Hold the pen with the needle pointing upwards.

D. Tap the insulin reservoir so that any air bubbles rise up towards the needle.

E. Press the injection button all the way in. Check if insulin comes out of the needle tip.

Press the injection button all the way in - illustration

You may have to perform the safety test several times before insulin is seen.

  • If no insulin comes out, check for air bubbles and repeat the safety test two more times to remove them.
  • If still no insulin comes out, the needle may be blocked. Change the needle and try again.
  • If no insulin comes out after changing the needle, your SoloStar® may be damaged. Do not use this SoloStar®.

Step 4. Select the dose

You can set the dose in steps of 1 unit, from a minimum of 1 unit to a maximum of 80 units. If you need a dose greater than 80 units, you should give it as two or more injections.

  1. Check that the dose window shows "0" following the safety test.
  2. Select your required dose (in the example below, the selected dose is 30 units). If you turn past your dose, you can turn back down.

Select your required dose  - illustration

  • Do not push the injection button while turning, as insulin will come out.
  • You cannot turn the dosage selector past the number of units left in the pen. Do not force the dosage selector to turn. In this case, either you can inject what is remaining in the pen and complete your dose with a new SoloStar® or use a new SoloStar® for your full dose.

Step 5. Inject the dose

A. Use the injection method as instructed by your healthcare professional.

B. Insert the needle into the skin.

Insert the needle into the skin - illustration

C. Deliver the dose by pressing the injection button in all the way. The number in the dose window will return to "0" as you inject.

Deliver the dose by pressing the injection button in all the way - illustration

D. Keep the injection button pressed all the way in.

Slowly count to 10 before you withdraw the needle from the skin. This ensures that the full dose will be delivered.

Step 6. Remove and discard the needle

Always remove the needle after each injection and store SoloStar without a needle attached. This helps prevent:

  • Contamination and/or infection
  • Entry of air into the insulin reservoir and leakage of insulin, which can cause inaccurate dosing.

A. Put the outer needle cap back on the needle, and use it to unscrew the needle from the pen. To reduce the risk of accidental needle injury, never replace the inner needle cap.

  • If your injection is given by another person, special caution must be taken by this person when removing and disposing the needle. Follow recommended safety measures for removal and disposal of needles (e.g. a one handed capping technique) in order to reduce the risk of accidental needle injury and transmission of infectious diseases.

B. Dispose of the needle safely. Used needles should be placed in sharps containers (such as red biohazard containers), hard plastic containers (such as detergent bottles), or metal containers (such as an empty coffee can). Such containers should be sealed and disposed of properly.
If you are giving an injection to a third person, you should remove the needle in an approved manner to avoid needle-stick injuries.

C.Always put the pen cap back on the pen, then store the pen until your next injection.

Last reviewed on RxList: 1/14/2008
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

LANTUS® (insulin glargine [rdna origin] injection) SOLOSTAR® 3 mL disposable insulin delivery device (300 units per device) 100 units per mL (U-100) (insulin glargine [recombinant DNA origin] injection)

  • What is the most important information I should know about LANTUS (insulin glargine [rdna origin] injection) ?
  • What is LANTUS (insulin glargine [rdna origin] injection) ?
  • Who should NOT take LANTUS (insulin glargine [rdna origin] injection) ?
  • How should I use LANTUS (insulin glargine [rdna origin] injection) ?
  • Mixing with LANTUS (insulin glargine [rdna origin] injection)
  • Instructions for Use
  • What can affect how much insulin I need?
  • What are the possible side effects of LANTUS (insulin glargine [rdna origin] injection) and other insulins?
  • How should I store LANTUS (insulin glargine [rdna origin] injection) ?
  • General Information about LANTUS (insulin glargine [rdna origin] injection)

Read this "Patient Information" that comes with LANTUS (insulin glargine [rdna origin] injection) (LAN-tus) before you start using it and each time you get a refill because there may be new information. This leaflet does not take the place of talking with your healthcare provider about your condition or treatment. If you have questions about LANTUS (insulin glargine [rdna origin] injection) or about diabetes, talk with your healthcare provider.

What is the most important information I should know about LANTUS (insulin glargine [rdna origin] injection) ?

  • Do not change the insulin you are using without talking to your healthcare provider. Any change of insulin should be made cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type (for example: Regular, NPH, analogs), species (beef, pork, beef-pork, human) or method of manufacture (recombinant DNA versus animal-source insulin) may need a change in the dose. This dose change may be needed right away or later on during the first several weeks or months on the new insulin. Doses of oral anti-diabetic medicines may also need to change, if your insulin is changed.
  • You must test your blood sugar levels while using an insulin, such as LANTUS (insulin glargine [rdna origin] injection) . Your healthcare provider will tell you how often you should test your blood sugar level, and what to do if it is high or low.
  • Do NOT dilute or mix LANTUS (insulin glargine [rdna origin] injection) with any other insulin or solution. It will not work and you may lose blood sugar control, which could be serious.
  • LANTUS (insulin glargine [rdna origin] injection) comes as U-100 insulin and contains 100 units of LANTUS (insulin glargine [rdna origin] injection) per milliliter (mL). One milliliter of U-100 insulin contains 100 units of insulin. (1 mL = 1 cc).

What is Diabetes?

  • Your body needs insulin to turn sugar (glucose) into energy. If your body does not make enough insulin, you need to take more insulin so you will not have too much sugar in your blood.
  • Insulin injections are important in keeping your diabetes under control. But the way you live, your diet, careful checking of your blood sugar levels, exercise, and planned physical activity, all work with your insulin to help you control your diabetes.

What is LANTUS (insulin glargine [rdna origin] injection) ?

  • LANTUS (insulin glargine [rdna origin] injection) (insulin glargine [recombinant DNA origin]) is a long-acting insulin. . Because Lantus (insulin glargine [rdna origin] injection) is made by recombinant DNA technology (rDNA) and is chemically different from the insulin made by the human body, it is called an insulin analog. LANTUS (insulin glargine [rdna origin] injection) is used to treat patients with diabetes for the control of high blood sugar. It is used once a day to lower blood glucose.
  • LANTUS (insulin glargine [rdna origin] injection) is a clear, colorless, sterile solution for injection under the skin (subcutaneously).
  • The active ingredient in LANTUS (insulin glargine [rdna origin] injection) is insulin glargine. The concentration of insulin glargine is 100 units per milliliter (mL), or U-100. LANTUS (insulin glargine [rdna origin] injection) also contains zinc, metacresol, glycerol, and water for injection as inactive ingredients. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH.
  • You need a prescription to get LANTUS (insulin glargine [rdna origin] injection) . Always be sure you receive the right insulin from the pharmacy.

Who should NOT take LANTUS (insulin glargine [rdna origin] injection) ?

Do not take LANTUS (insulin glargine [rdna origin] injection) if you are allergic to insulin glargine or any of the inactive ingredients in LANTUS (insulin glargine [rdna origin] injection) . Check with your healthcare provider if you are not sure.

  • Before starting LANTUS (insulin glargine [rdna origin] injection) , tell your healthcare provider about all your medical conditions including if you:
    • have liver or kidney problems. Your dose may need to be adjusted.
    • are pregnant or plan to become pregnant. It is not known if LANTUS (insulin glargine [rdna origin] injection) may harm your unborn baby. It is very important to maintain control of your blood sugar levels during pregnancy. Your healthcare provider will decide which insulin is best for you during your pregnancy.
    • are breast-feeding or plan to breast-feed. It is not known whether LANTUS (insulin glargine [rdna origin] injection) passes into your milk. Many medicines, including insulin, pass into human milk, and could affect your baby. Talk to your healthcare provider about the best way to feed your baby.
    • are taking any other medicines including prescription and non-prescription medicines, vitamins and herbal supplements.

How should I use LANTUS (insulin glargine [rdna origin] injection) ?

See the "Instructions for SoloStar® Use" section for additional information.

  • Follow the instructions given by your healthcare provider about the type or types of insulin you are using. Do not make any changes with your insulin unless you have talked to your healthcare provider. Your insulin needs may change because of illness, stress, other medicines, or changes in diet or activity level. Talk to your healthcare provider about how to adjust your insulin dose.
  • You may take LANTUS (insulin glargine [rdna origin] injection) at any time during the day but you must take it at the same time every day.
  • Only use LANTUS (insulin glargine [rdna origin] injection) that is clear and colorless. If your LANTUS (insulin glargine [rdna origin] injection) is cloudy or slightly colored, return it to your pharmacy for a replacement.
  • Follow your healthcare provider's instructions for testing your blood sugar.
  • Inject LANTUS (insulin glargine [rdna origin] injection) under your skin (subcutaneously) in your upper arm, abdomen (stomach area), or thigh (upper leg). Never inject it into a vein or muscle.
  • Change (rotate) injection sites within the same body area.
  • NEEDLES AND SOLOSTAR® MUST NOT BE SHARED.
  • Disposable needles should be used only once. Used needle should be placed in sharps containers (such as red biohazard containers), hard plastic containers (such as detergent bottles), or metal containers (such as an empty coffee can). Such containers should be sealed and disposed of properly.

Mixing with LANTUS (insulin glargine [rdna origin] injection)

  • Do NOT dilute or mix LANTUS (insulin glargine [rdna origin] injection) with any other insulin or solution. It will not work as intended and you may lose blood sugar control, which could be serious.

Instructions for SoloStar® Use

It is important to read, understand, and follow the step-by-step instructions in the "SoloStar® Instruction Leaflet" before using SoloStar® disposable insulin Pen. Failure to follow the instructions may result in getting too much or too little insulin. If you have lost your leaflet or have a question, go to www.lantus (insulin glargine [rdna origin] injection) .com or call 1-800-633-1610.

The following general notes should be taken into consideration before injecting Lantus (insulin glargine [rdna origin] injection) :

  • Always wash your hands before handling the SoloStar® disposable insulin Pen.
  • Always attach a new needle before use. BD Ultra-Fine™ needles† are compatible with SoloStar. These are sold separately and are manufactured by BD.
  • Always perform the safety test before use.
  • Check the insulin solution in the pen to make sure it is clear, colorless, and free of particles. If it is not, throw it away.
  • Do NOT mix or dilute LANTUS (insulin glargine [rdna origin] injection) with any other insulin or solution. LANTUS (insulin glargine [rdna origin] injection) will not work if it is mixed or diluted and you may lose blood sugar control, which could be serious.
  • Decide on an injection area - either upper arm, thigh, or abdomen. Do not use the same injection site as your last injection.
  • After injecting LANTUS (insulin glargine [rdna origin] injection) , leave the needle in the skin for an additional 10 seconds. Then pull the needle straight out. Gently press on the spot where you injected yourself for a few seconds. Do not rub the area.
  • Do not drop the SoloStar® disposable insulin Pen.

If your blood glucose reading is high or low, tell your healthcare provider so the dose can be adjusted.

What can affect how much insulin I need?

Illness. Illness may change how much insulin you need. It is a good idea to think ahead and make a "sick day" plan with your healthcare provider in advance so you will be ready when this happens. Be sure to test your blood sugar more often and call your healthcare provider if you are sick.

Medicines. Many medicines can affect your insulin needs. Other medicines, including prescription and non-prescription medicines, vitamins, and herbal supplements, can change the way insulin works. You may need a different dose of insulin when you are taking certain other medicines. Know all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. You may want to keep a list of the medicines you take. You can show this list to your healthcare provider and pharmacists anytime you get a new medicine or refill. Your healthcare provider will tell you if your insulin dose needs to be changed.

Meals. The amount of food you eat can affect your insulin needs. If you eat less food, skip meals, or eat more food than usual, you may need a different dose of insulin. Talk to your healthcare provider if you change your diet so that you know how to adjust your LANTUS (insulin glargine [rdna origin] injection) and other insulin doses.

Alcohol. Alcohol, including beer and wine, may affect the way LANTUS (insulin glargine [rdna origin] injection) works and affect your blood sugar levels. Talk to your healthcare provider about drinking alcohol.

Exercise or Activity level. Exercise or activity level may change the way your body uses insulin. Check with your healthcare provider before you start an exercise program because your dose may need to be changed.

Travel. If you travel across time zones, talk with your healthcare provider about how to time your injections. When you travel, wear your medical alert identification. Take extra insulin and supplies with you.

Pregnancy or nursing. The effects of LANTUS (insulin glargine [rdna origin] injection) on an unborn child or on a nursing baby are unknown. Therefore, tell your healthcare provider if you planning to have a baby, are pregnant, or nursing a baby. Good control of diabetes is especially important during pregnancy and nursing.

What are the possible side effects of LANTUS (insulin glargine [rdna origin] injection) and other insulins?

Insulins, including LANTUS (insulin glargine [rdna origin] injection) , can cause hypoglycemia (low blood sugar), hyperglycemia (high blood sugar), allergy, and skin reactions.

Hypoglycemia (low blood sugar):

Hypoglycemia is often called an "insulin reaction" or "low blood sugar". It may happen when you do not have enough sugar in your blood. Common causes of hypoglycemia are illness, emotional or physical stress, too much insulin, too little food or missed meals, and too much exercise or activity.

Early warning signs of hypoglycemia may be different, less noticeable or not noticeable at all in some people. That is why it is important to check your blood sugar as you have been advised by your healthcare provider.

Hypoglycemia can happen with:

  • Taking too much insulin. This can happen when too much insulin is injected.
  • Not enough carbohydrate (sugar or starch) intake. This can happen if a meal or snack is missed or delayed.
  • Vomiting or diarrhea that decreases the amount of sugar absorbed by your body.
  • Intake of alcohol.
  • Medicines that affect insulin. Be sure to discuss all your medicines with your healthcare provider. Do not start any new medicines until you know how they may affect your insulin dose.
  • Medical conditions that can affect your blood sugar levels or insulin. These conditions include diseases of the adrenal glands, the pituitary, the thyroid gland, the liver, and the kidney.
  • Too much glucose use by the body. This can happen if you exercise too much or have a fever.
  • Injecting insulin the wrong way or in the wrong injection area.

Hypoglycemia can be mild to severe. Its onset may be rapid. Some patients have few or no warning symptoms, including:

Hypoglycemia may reduce your ability to drive a car or use mechanical equipment and you may risk injury to yourself or others.

Severe hypoglycemia can be dangerous and can cause temporary or permanent harm to your heart or brain. It may cause unconsciousness, seizures, or death.

Symptoms of hypoglycemia may include:

If you have hypoglycemia often or it is hard for you to know if you have the symptoms of hypoglycemia, talk to your healthcare provider.

Mild to moderate hypoglycemia is treated by eating or drinking carbohydrates such as fruit juice, raisins, sugar candies, milk or glucose tablets. Talk to your healthcare provider about the amount of carbohydrates you should eat to treat mild to moderate hypoglycemia.

Severe hypoglycemia may require the help of another person or emergency medical people. A person with hypoglycemia who is unable to take foods or liquids with sugar by mouth, or is unconscious needs medical help fast and will need treatment with a glucagon injection or glucose given intravenously (IV). Without medical help right away, serious reactions or even death could happen.

Hyperglycemia (high blood sugar):

Hyperglycemia happens when you have too much sugar in your blood. Usually, it means there is not enough insulin to break down the food you eat into energy your body can use. Hyperglycemia can be caused by a fever, an infection, stress, eating more than you should, taking less insulin than prescribed, or it can mean your diabetes is getting worse.

Hyperglycemia can happen with:

  • Insufficient (too little) insulin. This can happen from:
    • - injecting too little or no insulin
    • - incorrect storage (freezing, excessive heat)
    • - use after the expiration date.
  • Too much carbohydrate intake. This can happen if you eat larger meals, eat more often, or increase the amount of carbohydrate in your meals.
  • Medicines that affect insulin. Be sure to discuss all your medicines with your healthcare provider. Do not start any new medicines until you know how they may affect your insulin dose.
  • Medical conditions that affect insulin. These medical conditions include fevers, infections, heart attacks, and stress.
  • Injecting insulin the wrong way or in the wrong injection area.

Testing your blood or urine often will let you know if you have hyperglycemia. If your tests are often high, tell your healthcare provider so your dose of insulin can be changed.

Hyperglycemia can be mild or severe. It can progress to diabetic ketoacidosis (DKA) or very high glucose levels (hyperosmolar coma) and result in unconsciousness and death.

Although diabetic ketoacidosis occurs most often in patients with type 1 diabetes,it can also happen in patients with type 2 diabetes who become very sick. Because some patients get few symptoms of hyperglycemia, it is important to check your blood sugar/urine sugar and ketones regularly.

Symptoms of hyperglycemia include:

  • confusion or drowsiness
  • increased thirst
  • decreased appetite, nausea, or vomiting
  • rapid heart rate
  • increased urination and dehydration (too little fluid in your body).

Symptoms of DKA also include:

Severe or continuing hyperglycemia or DKA needs evaluation and treatment right away by your healthcare provider.

Do not use LANTUS (insulin glargine [rdna origin] injection) to treat diabetic ketoacidosis.

Other possible side effects of LANTUS (insulin glargine [rdna origin] injection) include:

Serious allergic reactions

Some times severe, life-threatening allergic reactions can happen with insulin. If you think you are having a severe allergic reaction, get medical help right away. Signs of insulin allergy include:

Reactions at the injection site:

Injecting insulin can cause the following reactions on the skin at the injection site:

  • little depression in the skin (lipoatrophy)
  • skin thickening (lipohypertrophy)
  • red, swelling, itchy skin (injection site reaction).

You can reduce the chance of getting an injection site reaction if you change (rotate) the injection site each time. An injection site reaction should clear up in a few days or a few weeks. If injection site reactions do not go away or keep happening call your healthcare provider.

Tell your healthcare provider if you have any side effects that bother you.

These are not all the side effects of LANTUS (insulin glargine [rdna origin] injection) . Ask your healthcare provider or pharmacist for more information.

How should I store LANTUS (insulin glargine [rdna origin] injection) ?

  • Unopened SoloStar®:
    Store new unopened SoloStar® disposable insulin pen in a refrigerator (not the freezer) between 36°F to 46°F (2°C to 8°C). Do not freeze LANTUS (insulin glargine [rdna origin] injection) . Keep LANTUS (insulin glargine [rdna origin] injection) out of direct heat and light. If a disposable insulin pen has been frozen or overheated, throw it away.
  • Open (In-Use) SoloStar®:
    Once SoloStar® is opened (in-use), SoloStar® should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) SoloStar® kept at room temperature must be discarded after 28 days.

These storage conditions are summarized in the following table:

  Not in-use
(unopened)
Refrigerated
Not in-use
(unopened)
Room Temperature
In-use
(opened) Room Temperature
(Do not refrigerate)
3 mL SoloStar® disposable insulin device Until expiration date 28 days 28 days

  • Do not use SoloStar® with LANTUS (insulin glargine [rdna origin] injection) after the expiration date stamped on the label.
  • Do not use LANTUS (insulin glargine [rdna origin] injection) if it is cloudy, colored, or if you see particles.

General Information about LANTUS (insulin glargine [rdna origin] injection)

  • Use LANTUS (insulin glargine [rdna origin] injection) only to treat your diabetes. Do not give or share LANTUS (insulin glargine [rdna origin] injection) with another person, even if they have diabetes also. It may harm them.
  • This leaflet summarizes the most important information about LANTUS (insulin glargine [rdna origin] injection) . If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about LANTUS (insulin glargine [rdna origin] injection) that is written for healthcare professionals. For more information about LANTUS (insulin glargine [rdna origin] injection) call 1-800-633-1610 or go to website www.lantus (insulin glargine [rdna origin] injection) .com.

ADDITIONAL INFORMATION

DIABETES FORECAST is a national magazine designed especially for patients with diabetes and their families and is available by subscription from the American Diabetes Association (ADA), P.O. Box 363, Mt. Morris, IL 61054-0363, 1-800-DIABETES (1-800-342-2383). You may also visit the ADA website at www.diabetes.org.

Another publication, COUNTDOWN, is available from the Juvenile Diabetes Research Foundation International (JDRF), 120 Wall Street, 19th Floor, New York, New York 10005, 1- 800-JDF-CURE (1-800-533-2873). You may also visit the JDRF website at www.jdf.org.

To get more information about diabetes, check with your healthcare professional or diabetes educator or visit www.DiabetesWatch.com.

Additional information about LANTUS (insulin glargine [rdna origin] injection) can be obtained by calling 1-800-633-1610 or by visiting www.lantus (insulin glargine [rdna origin] injection) .com.

LANTUS® SOLOSTAR®
(insulin glargine [rDNA origin] injection)

Instruction Leaflet

Your healthcare professional has decided that SoloStar® is right for you. Talk with your healthcare professional about proper injection technique before using SoloStar®.

Read these instructions carefully before using your SoloStar®. If you are not able to follow all the instructions completely on your own, use SoloStar® only if you have help from a person who is able to follow the instructions.

Follow these instructions completely each time you use SoloStar® to ensure that you get an accurate dose. If you do not follow these instructions you may get too much or too little insulin, which may affect your blood glucose.

SoloStar® is a disposable pen for the injection of insulin. Each SoloStar® contains in total 300 units of insulin. You can set doses from 1 to 80 units in steps of 1 unit.

Keep this leaflet for future reference.

If you have any questions about Solostar® or about diabetes, ask your healthcare professional, go to www.lantus (insulin glargine [rdna origin] injection) .com or call sanofi aventis at 1-800-633-1610.

SoloStar®  disposable pen for the injection - illustration

Important information for use of SoloStar®:

  • Always attach a new needle before each use.
    BD Ultra-Fine needles are compatible with SoloStar® . These are sold separately and are manufactured by BD. Contact your healthcare professional for further information.
  • Always perform the safety test before each injection.
  • This pen is only for your use. Do not share it with anyone else.
  • If your injection is given by another person, special caution must be taken by this person to avoid accidental needle injury and transmission of infection.
  • Never use SoloStar® if it is damaged or if you are not sure that it is working properly.
  • Always have a spare SoloStar® in case your SoloStar® is lost or damaged.

Storage Instructions

Please check the leaflet for the insulin for complete instructions on how to store SoloStar®.

If your SoloStar® is in cool storage, take it out 1 to 2 hours before you inject to allow it to warm up. Cold insulin is more painful to inject.

Keep SoloStar® out of the reach and sight of children.

Keep your SoloStar® in cool storage (36°F - 46°F [2°C - 8°C]) until first use. Do not allow it to freeze. Do not put it next to the freezer compartment of your refrigerator, or next to a freezer pack.

Once you take your SoloStar® out of cool storage, for use or as a spare, you can use it for up to 28 days. During this time it can be safely kept at room temperature up to 86°F (30°C). Do not use it after this time. SoloStar® in use must not be stored in a refrigerator.

Do not use SoloStar® after the expiration date printed on the label of the pen or on the carton.

Protect SoloStar® from light.

Discard your used SoloStar® as required by your local authorities.

Maintenance

Protect your SoloStar® from dust and dirt.

You can clean the outside of your SoloStar® by wiping it with a damp cloth.

Do not soak, wash or lubricate the pen as this may damage it.

Your SoloStar® is designed to work accurately and safely. It should be handled with care. Avoid situations where SoloStar® might be damaged. If you are concerned that your SoloStar® may be damaged, use a new one.

Step 1. Check the insulin

  1. Check the label on your SoloStar® to make sure you have the correct insulin.. The Lantus® (insulin glargine [rdna origin] injection) SoloStar® is grey with a purple injection button.
  2. Take off the pen cap.
  3. Check the appearance of your insulin. Lantus® (insulin glargine [rdna origin] injection) is a clear insulin. Do not use this SoloStar® if the insulin is cloudy, colored or has particles.

Step 2. Attach the needle

Always use a new sterile needle for each injection. This helps prevent contamination, and potential needle blocks.

  1. Wipe the Rubber Seal with alcohol.
  2. Remove the protective seal from a new needle.
  3. Line up the needle with the pen, and keep it straight as you attach it (screw or push on, depending on the needle type).

Line up the needle with the pen, and keep it straight as you attach it - illustration

  • If the needle is not kept straight while you attach it, it can damage the rubber seal and cause leakage, or break the needle.

If the needle is not kept straight while you attach it, it can damage the rubber seal and cause leakage, or break the needle - illustration

Step 3. Perform a Safety test

Always perform the safety test before each injection.

Performing the safety test ensures that you get an accurate dose by:

  • ensuring that pen and needle work properly
  • removing air bubbles

A. Select a dose of 2 units by turning the dosage selector.

Select a dose of 2 units by turning the dosage selector - illustration

B. Take off the outer needle cap and keep it to remove the used needle after injection. Take off the inner needle cap and discard it.

Take off the outer needle cap and keep it to remove the used needle after injection - illustration

C. Hold the pen with the needle pointing upwards.

D. Tap the insulin reservoir so that any air bubbles rise up towards the needle.

E. Press the injection button all the way in. Check if insulin comes out of the needle tip.

Press the injection button all the way in - illustration

You may have to perform the safety test several times before insulin is seen.

  • If no insulin comes out, check for air bubbles and repeat the safety test two more times to remove them.
  • If still no insulin comes out, the needle may be blocked. Change the needle and try again.
  • If no insulin comes out after changing the needle, your SoloStar® may be damaged. Do not use this SoloStar®.

Step 4. Select the dose

You can set the dose in steps of 1 unit, from a minimum of 1 unit to a maximum of 80 units. If you need a dose greater than 80 units, you should give it as two or more injections.

  1. Check that the dose window shows "0" following the safety test.
  2. Select your required dose (in the example below, the selected dose is 30 units). If you turn past your dose, you can turn back down.

Select your required dose  - illustration

  • Do not push the injection button while turning, as insulin will come out.
  • You cannot turn the dosage selector past the number of units left in the pen. Do not force the dosage selector to turn. In this case, either you can inject what is remaining in the pen and complete your dose with a new SoloStar® or use a new SoloStar® for your full dose.

Step 5. Inject the dose

A. Use the injection method as instructed by your healthcare professional.

B. Insert the needle into the skin.

Insert the needle into the skin - illustration

C. Deliver the dose by pressing the injection button in all the way. The number in the dose window will return to "0" as you inject.

Deliver the dose by pressing the injection button in all the way - illustration

D. Keep the injection button pressed all the way in.

Slowly count to 10 before you withdraw the needle from the skin. This ensures that the full dose will be delivered.

Step 6. Remove and discard the needle

Always remove the needle after each injection and store SoloStar without a needle attached. This helps prevent:

  • Contamination and/or infection
  • Entry of air into the insulin reservoir and leakage of insulin, which can cause inaccurate dosing.

A. Put the outer needle cap back on the needle, and use it to unscrew the needle from the pen. To reduce the risk of accidental needle injury, never replace the inner needle cap.

  • If your injection is given by another person, special caution must be taken by this person when removing and disposing the needle. Follow recommended safety measures for removal and disposal of needles (e.g. a one handed capping technique) in order to reduce the risk of accidental needle injury and transmission of infectious diseases.

B. Dispose of the needle safely. Used needles should be placed in sharps containers (such as red biohazard containers), hard plastic containers (such as detergent bottles), or metal containers (such as an empty coffee can). Such containers should be sealed and disposed of properly.
If you are giving an injection to a third person, you should remove the needle in an approved manner to avoid needle-stick injuries.

C.Always put the pen cap back on the pen, then store the pen until your next injection.

Last reviewed on RxList: 1/14/2008
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Lantus 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.

INSULIN GLARGINE - INJECTION

(IN-su-lin GLAR-jeen)

COMMON BRAND NAME(S): Lantus

USES: Insulin glargine is used along with a proper diet and exercise program to control high blood sugar. It is used in people with type 1 (insulin-dependent) or type 2 (non-insulin-dependent) diabetes. Insulin glargine is a man-made, long-acting type of insulin that is similar to human insulin. It starts working more slowly and lasts for a longer time than regular insulin.

Insulin is a natural substance that allows the body to properly use sugar from the diet. It replaces the insulin that your body no longer produces, thereby lowering your blood sugar. 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.

HOW TO USE: Read the patient information leaflet provided by your pharmacist before you start using this medication and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Follow all package directions for proper use/injection/storage of the particular type of device/insulin you are using. Your health care professional will teach you how to properly inject this medication. If any of the information is unclear, consult your doctor or pharmacist.

Do not inject cold insulin because this can be painful. The insulin container you are currently using can be kept at room temperature (see also Storage section). Wash your hands before measuring and injecting insulin. Before using, check the product visually for particles, thickening, or clumps. If any are present, discard that container. Insulin glargine should be clear and colorless. To avoid damaging the insulin, do not shake the container.

The dosage is based on your medical condition and response to treatment. Measure each dose carefully, and use exactly as prescribed by your doctor. Even small changes in the amount of insulin may have a large effect on your blood sugar levels. If you are using the cartridge form of this insulin and a special injecting device with a digital display, take care to read the display right-side up. If you read the display upside-down, you may inject the wrong amount of insulin. Ask your pharmacist if you are unsure how to properly use this type of injecting device.

Before injecting each dose, make sure the injection site is clean and dry. Inject this medication under the skin of the abdomen, upper arms, or thighs, usually once daily or as directed by your doctor. Do not rub the injection site. Do not inject into a vein or muscle. Change the location of the injection site daily and do not reuse the same site for two weeks to avoid problem areas under the skin.

Use this medication regularly as directed by your doctor in order to get the most benefit from it. You may inject insulin glargine once daily at any time during the day (such as before breakfast or at bedtime) but you should inject at the same time each day. Carefully follow the insulin treatment plan, meal plan, and exercise program your doctor has recommended.

Do not mix this product with other insulins or solutions, or use it in an insulin pump.

Monitor your blood sugar on a regular basis. Keep track of the results, and share them with your doctor. This is very important in order to determine the correct insulin dose. Inform your doctor if your blood sugar measurements are too high or too low. Your dosage may need to be changed.

If you are measuring doses from vials, do not reuse needles and syringes. If you are using the cartridges or pens, use a new needle each time. Learn how to discard needles and medical supplies safely. Consult your pharmacist for more information.

Disclaimer

Lantus Consumer (continued)

SIDE EFFECTS: See also the How to Use section.

Pain, redness, swelling or itching at the injection site may occur. These effects usually go away after a few days or weeks. If any of these effects persist or worsen, notify 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.

Too much insulin can cause low blood sugar (hypoglycemia). This effect may also occur if you do not consume enough calories. The symptoms include chills, cold sweats, blurred vision, dizziness, drowsiness, shaking, fast heartbeat, weakness, headache, fainting, tingling of the hands/feet, or hunger. It is a good habit to carry glucose (sugar) tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, raise your blood sugar quickly by eating a quick source of sugar such as table sugar, honey, candy, or drinking a glass of fruit juice or non-diet soda. Tell your doctor immediately about the reaction. To help prevent low blood sugar, eat meals on a regular schedule and do not skip meals.

Too little insulin can cause high blood sugar (hyperglycemia). Symptoms of high blood sugar include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, or fruity breath odor. If these symptoms occur, tell your doctor immediately. Your treatment plan may need to be changed.

This medication may cause low potassium levels in the blood (hypokalemia). Tell your doctor immediately if any of these unlikely but serious side effects occur: muscle cramps, weakness, irregular heartbeat.

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 Lantus (insulin glargine [rdna origin] injection) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease.

Use only the insulin product that your doctor has prescribed for you. Do not change the insulin you use unless your doctor has given you instructions on how to do so. Follow your doctor's instructions carefully. Following a change in insulin, you may need a dosage change. Know the symptoms of low blood sugar and high blood sugar (see Side Effects section). Tell your doctor immediately if you experience symptoms of high or low blood sugar.

Do not use this medication when you have low blood sugar.

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 alcohol while taking this medication because it can increase the risk of developing low blood sugar.

During times of stress, such as fever, infection, injury, or surgery, it may be more difficult to control your blood sugar. Consult your doctor because a change in your treatment plan may be required.

Changes in your lifestyle or activity level may affect the amount of insulin your body needs to control blood sugar levels. If you notice an unusual change in your insulin needs, tell your doctor.

Check your blood sugar before and after exercise. You may need a snack before exercising.

If traveling across more than two time zones, ask your doctor about how to adjust your insulin schedule.

Tell your doctor if you are pregnant before using this medication. If you are planning pregnancy, discuss a plan for managing your blood sugars with your doctor before you become pregnant. Your doctor may switch the type of insulin you use during pregnancy. Consult your doctor for more details.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding. Your insulin needs may change while breast-feeding.

Disclaimer

Lantus Consumer (continued)

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

A product that may interact with this drug is: rosiglitazone.

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. Effects section.) Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Beta-blocker medications (such as 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.

Check the labels on all your medicines (such as cough-and-cold products) carefully. Some products may contain sugar or alcohol and may affect your blood sugar levels. Ask your doctor or pharmacist about using these products safely.

Other medications can affect the results of urine tests for sugar or ketones. Consult your doctor or pharmacist for more information.

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: very fast heartbeat, vision changes, unexplained heavy sweating, agitation, fainting, seizures.

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

Attend a diabetes education program to learn more about diabetes and the important aspects of its treatment, including medications, diet, exercise, and getting regular eye/foot/medical exams. Learn the symptoms of high and low blood sugar and how to treat low blood sugar.

Check your blood sugar levels regularly as directed. Keep all medical appointments. Laboratory and/or medical tests (such as fasting blood glucose, hemoglobin A1c) should be performed periodically to check for side effects and monitor your response to treatment.

Wear or carry identification stating that you have diabetes and are using this drug.

MISSED DOSE: It is very important to follow your insulin regimen exactly. Do not miss any doses of insulin. Keep extra supplies of insulin and an extra syringe and needle on hand. Discuss specific instructions with your doctor now in case you miss a dose of insulin in the future.

STORAGE: See also the How to Use section.

Store all unopened insulin containers in the refrigerator between 36-46 degrees F (2-8 degrees C). Do not freeze, and do not use insulin that has been frozen. If you are using the vials, store open vials in the refrigerator or at room temperature below 86 degrees F (30 degrees C) away from direct heat and light. Store in the carton to protect from light. Do not refrigerate cartridges or pens that are currently in use. Discard all containers in use after 28 days, even if there is insulin left. Also discard all insulin products after the expiration date on the package. Do not store in the bathroom. 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 enrollment information call MedicAlert at 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

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

Lantus Patient Information Including Side Effects

Brand Names: Lantus, Lantus OptiClik Cartridge, Lantus Solostar Pen

Generic Name: insulin glargine (Pronunciation: IN soo lin GLAR jeen)

What is insulin glargine (Lantus)?

Insulin glargine is a man-made form of a hormone that is produced in the body. It works by lowering levels of glucose (sugar) in the blood. Insulin glargine is a long-acting form of insulin that is slightly different from other forms of insulin that are not man-made.

Insulin glargine is used to treat type 1 (insulin-dependent) or type 2 (non insulin-dependent) diabetes.

Insulin glargine may also be used for purposes not listed in this medication guide.

What are the possible side effects of insulin glargine (Lantus)?

Get emergency medical help if you have any of these signs of insulin allergy: itching skin rash over the entire body, wheezing, trouble breathing, fast heart rate, sweating, or feeling like you might pass out.

Hypoglycemia, or low blood sugar, is the most common side effect of insulin glargine. Symptoms include headache, hunger, weakness, sweating, tremors, irritability, trouble concentrating, rapid breathing, fast heartbeat, fainting, or seizure (severe hypoglycemia can be fatal). Carry hard candy or glucose tablets with you in case you have low blood sugar.

Tell your doctor if you have itching, swelling, redness, or thickening of the skin where you inject insulin glargine.

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 Lantus (insulin glargine [rdna origin] injection) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about insulin glargine (Lantus)?

Take care not to let your blood sugar get too low. Low blood sugar (hypoglycemia) can occur if you skip a meal, exercise too long, drink alcohol, or are under stress. Symptoms include headache, hunger, weakness, sweating, tremors, irritability, or trouble concentrating. Carry hard candy or glucose tablets with you in case you have low blood sugar. Other sugar sources include orange juice and milk. Be sure your family and close friends know how to help you in an emergency.

Also watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss. Your blood sugar will need to be checked often, and you may need to adjust your insulin glargine dose.

Insulin glargine is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

Side Effects Centers

Lantus Patient Information including How Should I Take

What should I discuss with my healthcare provider before using insulin glargine (Lantus)?

Do not use this medication if you are allergic to insulin glargine.

To make sure you can safely take insulin glargine, tell your doctor if you have liver or kidney disease.

FDA pregnancy category C. It is not known whether insulin glargine is harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether insulin glargine 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.

How should I use insulin glargine (Lantus)?

Insulin glargine is injected under the skin. You may be shown how to use injections at home. 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. You should not mix this medication with other insulins.

Insulin glargine should be thin, clear, and colorless. Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription.

Use a different place in your injection skin area each time you give the injection. Your care provider will show you the best places on your body to inject the medication. Do not inject into the same place two times in a row.

Use a disposable needle only once. 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.

The SoloStar injection pen contains a total of 300 units of insulin. The pen is designed to deliver from 1 to 80 units with each press of the injection button. Do not press the button more than one time per injection unless your doctor has prescribed a dose greater than 80 units.

Never share an injection pen or cartridge with another person. Sharing injection pens or cartridges can allow disease such as hepatitis or HIV to pass from one person to another.

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.

Your dose needs may change if you become ill, have a fever or infection, or if you have surgery or a medical emergency. Your doctor may want you to stop taking insulin glargine for a short time if any of these situations affect you. Ask your doctor how to adjust your insulin glargine dose if needed. Do not change your medication dose or schedule without your doctor's advice.

Know the signs of low blood sugar (hypoglycemia) and how to recognize them: headache, hunger, weakness, sweating, tremors, irritability, or trouble concentrating.

Always keep a source of sugar available in case you have symptoms of low blood sugar. Sugar sources include orange juice, glucose gel, candy, or milk. 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.

Also watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss.

Check your blood sugar carefully during a time of stress or illness, if you travel, exercise more than usual, drink alcohol, or skip meals. These things can affect your glucose levels and your dose needs may also change.

Insulin glargine is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

Wear a medical alert tag or carry an ID card stating that you use insulin. Any medical care provider who treats you should know that you are diabetic.

Unopened vials, OptiClik, or SoloStar devices may also be stored at room temperature for up to 28 days, away from heat and bright light. Throw away any insulin not used within 28 days.

Storing after your first use: You may keep "in-use" vials or cartridges not yet loaded into the OptiClik in the refrigerator or at room temperature, protected from light. Use within 28 days.

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

Side Effects Centers

Lantus Patient Information including If I Miss a Dose

What happens if I miss a dose (Lantus)?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose. You should not use more than one dose in a 24-hour period unless your doctor tells you to.

Keep insulin glargine on hand at all times. Get your prescription refilled before you run out of medicine completely.

What happens if I overdose (Lantus)?

Seek emergency medical attention if you think you have used too much of this medicine. An insulin overdose can cause life-threatening hypoglycemia.

What should I avoid while using insulin glargine (Lantus)?

Avoid drinking alcohol. It lowers blood sugar and may interfere with your diabetes treatment.

What other drugs will affect insulin glargine (Lantus)?

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);
  • reserpine; 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.

Where can I get more information?

Your pharmacist can provide more information about insulin glargine.


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.

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