Benefix (Coagulation Factor IX Recombinant)
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Benefix (Coagulation Factor IX Recombinant)

BeneFIX®
[coagulation factor IX (recombinant)]

DRUG DESCRIPTION

BeneFIX®, Coagulation Factor IX (Recombinant), is a purified protein produced by recombinant DNA technology for use in therapy of factor IX deficiency, known as hemophilia B or Christmas disease. Coagulation Factor IX (Recombinant) is a glycoprotein with an approximate molecular mass of 55,000 Da consisting of 415 amino acids in a single chain. It has a primary amino acid sequence that is identical to the Ala148allelic form of plasma-derived factor IX, and has structural and functional characteristics similar to those of endogenous factor IX.

BeneFIX® (coagulation factor ix recombinant) is produced by a genetically engineered Chinese hamster ovary (CHO) cell line that is extensively characterized and shown to be free of known infectious agents. The stored cell banks are free of blood or plasma products. The CHO cell line secretes recombinant factor IX into a defined cell culture medium that does not contain any proteins derived from animal or human sources, and the recombinant factor IX is purified by a chromatography purification process that does not require a monoclonal antibody step and yields a high-purity, active product. A membrane filtration step that has the ability to retain molecules with apparent molecular weights >70,000 (such as large proteins and viral particles) is included for additional viral safety. BeneFIX® (coagulation factor ix recombinant) is predominantly a single component by SDS-polyacrylamide gel electrophoresis evaluation. The potency (in international units, IU) is determined using an in vitro one-stage clotting assay against the World Health Organization (WHO) International Standard for Factor IX concentrate. One international unit is the amount of factor IX activity present in 1 mL of pooled, normal human plasma. The specific activity of BeneFIX® (coagulation factor ix recombinant) is greater than or equal to 200 IU per milligram of protein. BeneFIX® (coagulation factor ix recombinant) is not derived from human blood and contains no preservatives or added animal or human components.

BeneFIX® (coagulation factor ix recombinant) is inherently free from the risk of transmission of human blood-borne pathogens such as HIV, hepatitis viruses, and parvovirus.

BeneFIX® (coagulation factor ix recombinant) is formulated as a sterile, nonpyrogenic, lyophilized powder preparation. BeneFIX® (coagulation factor ix recombinant) is intended for intravenous (IV) injection. It is available in single use vials containing the labeled amount of factor IX activity, expressed in international units (IU). Each vial contains nominally 250, 500, or 1000 IU of Coagulation Factor IX (Recombinant). After reconstitution of the lyophilized drug product, the concentrations of excipients in the 500 and 1000 IU dosage strengths are 10 mM L-histidine, 1% sucrose, 260 mM glycine, 0.005% polysorbate 80. The concentrations after reconstitution in the 250 IU dosage strength are half those of the other two dosage strengths. The 500 and 1000 IU dosage strengths are isotonic after reconstitution, and the 250 IU dosage strength has half the tonicity of the other two dosage strengths after reconstitution. All dosage strengths yield a clear, colorless solution upon reconstitution.

What are the possible side effects of coagulation factor IX (Alphanine SD, Benefix, Mononine)?

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

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

  • fever or chills;
  • continued bleeding after treatment;
  • feeling like you might pass out;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance; or
  • swelling in your feet or ankles, weight...

Read All Potential Side Effects and See Pictures of Benefix »

What are the precautions when taking coagulation factor ix recombinant (Benefix)?

Before using factor IX, tell your doctor or pharmacist if you are allergic to factor IX products; or to hamster protein; or if you have any other allergies. This product may contain inactive ingredients (such as latex), 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: other clotting disorders (e.g., disseminated intravascular coagulation-DIC), recent surgery/procedure, liver disease.

Before having surgery, tell your doctor or dentist that you are using this medication.

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

It is not known whether...

Read All Potential Precautions of Benefix »

Last reviewed on RxList: 9/18/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

BeneFIX®, Coagulation Factor IX (Recombinant), is indicated for the control and prevention of hemorrhagic episodes in patients with hemophilia B (congenital factor IX deficiency or Christmas disease), including control and prevention of bleeding in surgical settings.

BeneFIX®, Coagulation Factor IX (Recombinant), is not indicated for the treatment of other factor deficiencies (e.g., factors II, VII, VIII, and X), nor for the treatment of hemophilia A patients with inhibitors to factor VIII, nor for the reversal of coumarin-induced anticoagulation, nor for the treatment of bleeding due to low levels of liver-dependent coagulation factors.

DOSAGE AND ADMINISTRATION

The safety and efficacy of BeneFIX® (coagulation factor ix recombinant) administration by continuous infusion have not been established (see WARNINGS).

Treatment with BeneFIX®, Coagulation Factor IX (Recombinant), should be initiated under the supervision of a physician experienced in the treatment of hemophilia B.

Dosage and duration of treatment for all factor IX products depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition, age and recovery of factor IX.

To ensure that the desired factor IX activity level has been achieved, precise monitoring using the factor IX activity assay is advised. Doses should be titrated using the factor IX activity, pharmacokinetic parameters, such as half-life and recovery, as well as taking the clinical situation into consideration in order to adjust the dose as appropriate.

In an eleven subject, crossover, randomized PK evaluation of BeneFIX® (coagulation factor ix recombinant) and a single lot of highpurity plasma-derived factor IX, the recovery was lower for BeneFIX® (see CLINICAL PHARMACOLOGY). In the clinical efficacy studies, subjects were initially administered the same dose previously used for plasma-derived factor IX. Even in the absence of factor IX inhibitor, approximately half of the subjects increased their dose in these studies. Titrate the initial dose upward if necessary to achieve the desired clinical response. As with some plasmaderived factor IX products, subjects at the low end of the observed factor IX recovery may require upward dosage adjustment to as much as two times (2X) the initial empirically calculated dose in order to achieve the intended rise in circulating factor IX activity.

BeneFIX® (coagulation factor ix recombinant) is administered by IV infusion over several minutes after reconstitution of the lyophilized powder with Sterile Water for Injection (USP).

Method of Calculating

Dose The method of calculating the factor IX dose is shown in the following equation:

number of factor IXIU required (IU) = body weight (kg) x Desired factor IX increase (% or IU/dL) x reciprocal of observed recovery (IU/kg per IU/dL)

In the presence of an inhibitor, higher doses may be required.

Adult Patients

In adult PTPs, on average, one international unit of BeneFIX® (coagulation factor ix recombinant) per kilogram of body weight increased the circulating activity of factor IX by 0.8 ± 0.2 (range 0.4 to 1.4) IU/dL. The method of dose estimation is illustrated in the following example. If you use 0.8 IU/dL average increase of factor IX per IU/kg body weight administered, then:

number of factor IXIU required (IU) = body weight (kg) x desired factor IX increase (% or IU/dL) x 1.2 (IU/kg per IU/dL)

Pediatric Patients (<15 years)

In pediatric patients, on average, one international unit of BeneFIX® (coagulation factor ix recombinant) per kilogram of body weight increased the circulating activity of factor IX by 0.7 ± 0.3 (range 0.2 to 2.1 IU/dL; median of 0.6 IU/dL per IU/kg). The method of dose estimation is illustrated in the following example. If you use 0.7 IU/dL average increase of factor IX per IU/kg body weight administered, then:

number of factor IXIU required (IU) = body weight (kg) x desired factor IX increase (% or IU/dL) x 1.4 (IU/kg per IU/dL)

The following chart3 may be used to guide dosing in bleeding episodes and surgery:

Type of Hemorrhage Circulating Factor IX Activity Required [% or(IU/dL)] Dosing Interval [hours] Durationof Therapy [days]
Minor
  Uncomplicated hemarthroses, superficial muscle, or soft tissue 20-30 12-24 1-2
Moderate
  Intramuscle or soft tissue with dissection, mucous membranes, dental extractions, or hematuria 25-50 12-24 Treat until bleeding stops and healing begins; about 2 to 7 days
Major
  Phary nx, retropharynx, retroperitoneum, CNS, surgery 50-100 12-24 7-10
Adapted from: Roberts and Eberst3

Instruction For use

The procedures below are provided as general guidelines for the reconstitution and administration of BeneFIX® (coagulation factor ix recombinant) . Patients should follow the specific reconstitution and administration procedures provided by their physicians.

Reconstitution

Always wash your hands before performing the following procedures. Aseptic technique should be used during the reconstitution procedure. BeneFIX®, Coagulation Factor IX (Recombinant), will be administered by intravenous (IV) infusion after reconstitution with Sterile Water for Injection (diluent).

  1. Allow the vials of lyophilized BeneFIX® (coagulation factor ix recombinant) and diluent to reach room temperature.
  2. Remove the plastic flip-top caps from the BeneFIX® (coagulation factor ix recombinant) vial and the diluent vial to expose the central portions of the rubber stoppers.
  3. Wipe the tops of both vials with the alcohol swab provided, or use another antiseptic solution, and allow to dry.
  4. 4. Remove the protective cover from the short end of the sterile double-ended needle and insert the short end into the diluent vial at the center of the stopper.
  5. 5. Remove the protective cover from the long end of the needle. Invert the solvent vial and, to minimize leakage, quickly insert the long end of the needle through the center of the stopper of the upright BeneFIX® (coagulation factor ix recombinant) vial.
    Note: Point the double-ended needle toward the wall of the BeneFIX® (coagulation factor ix recombinant) vial to prevent excessive foaming.
  6. The vacuum will draw the diluent into the BeneFIX® (coagulation factor ix recombinant) vial.
  7. Once the transfer is complete, remove the long end of the needle from the BeneFIX® (coagulation factor ix recombinant) vial, and properly discard the needle with the diluent vial.
    Note: If the diluent does not transfer completely into the BeneFIX® (coagulation factor ix recombinant) vial, DO NOT USE the contents of the vial. Note that it is acceptable for a small amount of fluid to remain in the diluent vial after transfer.
  8. Gently rotate the vial to dissolve the powder.
  9. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Reconstituted BeneFIX® (coagulation factor ix recombinant) should appear clear and colorless.

BeneFIX® (coagulation factor ix recombinant) should be administered within 3 hours after reconstitution. The reconstituted solution may be stored at room temperature prior to administration.

BeneFIX® (coagulation factor ix recombinant) , when reconstituted, contains polysorbate-80, which is known to increase the rate of di-(2-ethylhexyl)phthalate (DEHP) extraction from polyvinyl chloride (PVC). This should be considered during the preparation and administration of BeneFIX® (coagulation factor ix recombinant) , including storage time elapsed in a PVC container following reconstitution. It is important that the recommendations in DOSAGE AND ADMINISTRATION be followed closely.

Administration (Intravenous Injection)

BeneFIX®, Coagulation Factor IX (Recombinant), should be administered using a single sterile disposable plastic syringe. In addition, the solution should be withdrawn from the vial using the sterile filter spike.

  1. Using aseptic technique, attach the sterile filter spike to the sterile disposable syringe.
    Note: Do NOT inject air into the BeneFIX® (coagulation factor ix recombinant) vial. This may cause partial loss of product.
  2. Insert the filter spike end into the stopper of the BeneFIX® (coagulation factor ix recombinant) vial.
  3. Invert the vial and withdraw the reconstituted solution into the syringe.
  4. Remove and discard the filter spike. Note: If you use more than one vial of BeneFIX® (coagulation factor ix recombinant) , the contents of multiple vials may be drawn into the same syringe through a separate, unused filter spike.
  5. Attach the syringe to the Luer end of the infusion set tubing and perform venipuncture as instructed by your physician.
    Note: Agglutination of red blood cells in the tubing/syringe has been reported with the administration of BeneFIX® (coagulation factor ix recombinant) . No adverse events have been reported in association with this observation. To minimize the possibility of agglutination, it is important to limit the amount of blood entering the tubing. Blood should not enter the syringe. If red blood cell agglutination is observed in the tubing or syringe, discard all material (tubing, syringe and BeneFIX® (coagulation factor ix recombinant) solution) and resume administration with a new package.

After reconstitution, BeneFIX® (coagulation factor ix recombinant) should be injected intravenously over several minutes. The rate of administration should be determined by the patient's comfort level (see ADVERSE REACTIONS). The safety and efficacy of administration by continuous infusion have not been established (see WARNINGS and ADVERSE REACTIONS, Post-marketing Experience).

Dispose of all unused solution, empty vials, and used needles and syringes in an appropriate container for throwing away waste that might hurt others if not handled properly.

Storage

Product as packaged for sale: BeneFIX®, Coagulation Factor IX (Recombinant), should be stored under refrigeration at a temperature of 2 to 8°C (36 to 46°F). Prior to the expiration date, BeneFIX® (coagulation factor ix recombinant) may also be stored at room temperature not to exceed 25°C (77°F) for up to 6 months. The patient should make note of the date the product was placed at room temperature in the space provided on the outer carton. Freezing should be avoided to prevent damage to the diluent vial. Do not use BeneFIX® (coagulation factor ix recombinant) after the expiry date on the label.

Product after reconstitution: The product does not contain a preservative and should be used within 3 hours.

HOW SUPPLIED

BeneFIX®, Coagulation Factor IX (Recombinant), is supplied in single use vials which contain nominally 250, 500, or 1000 IU per vial (NDC # 58394-003-01, 58394-002-01, and 58394-001- 01, respectively) with sterile diluent, sterile double-ended needle for reconstitution, sterile filter spike for withdrawal, sterile infusion set, and two (2) alcohol swabs. Actual factor IX activity in IU is stated on the label of each vial.

REFERENCES

3. Roberts HR, Eberst ME. Current management of hemophilia B. Hematol Oncol Clin North Am. 1993;7(6):1269-1280.

This product's label may have been updated. For current package insert and further product information, please visit www.wyeth.com or call our medical communications department toll-free at 1-800-934-5556. Wyeth Pharmaceuticals Inc. Philadelphia, PA 19101. Rev 02/08. FDA Rev date: 7/11/2006

Last reviewed on RxList: 9/18/2008
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

See also CLINICAL PHARMACOLOGY: Clinical Studies.

As with the intravenous administration of any protein product, the following reactions may be observed after administration: headache, fever, chills, flushing, nausea, vomiting, lethargy, or manifestations of allergic reactions. Should evidence of an acute hypersensitivity reaction be observed, the infusion should be stopped promptly and appropriate counter measures and supportive therapy should be administered.

During uncontrolled open-label clinical studies with BeneFIXR, Coagulation Factor IX (Recombinant), conducted in previously treated patients (PTPs), 131 adverse reactions with definite, probable, possible or unknown relation to BeneFIX (coagulation factor ix recombinant) R therapy were reported among 27 of 65 subjects (with some subjects reporting more than one event) who received a total of 7573 infusions. These adverse reactions are summarized in Table 1 below.

Table 1: Adverse Events Reported for PTPs*

Reaction Total number of events with definite, probable, possible or unknown relation to therapy
(n=129)
Number and (%) of patients from which the reports originated
(n=65)
Number and (%) of infusions temporally associated with thereaction1
(n=7573)
Nausea 27 4 (6.2 %) 27 (0.36 %)
Taste perversion (Altered taste) 14 3 (4.6 %) 19 (0.25 %)
Hypoxia (Urge to cough with hypoxemia) 11 1 (1.5 %) 11 (0.15 %)
Injection site reaction 11 5 (7.7 %) 12 (0.16 %)
Injection site pain 10 4 (6.2 %) 16 (0.21 %)
Headache 10 7 (10.8 %) 13 (0.17 %)
Dizziness 7 5 (7.7 %) 8 (0.11 %)
Allergic rhinitis 7 3 (4.6 %) 9 (0.12 %)
Pain (Burning sensation in the jaw and skull) 6 1 (1.5 %) 7 (0.09 %)
Rash 6 5 (7.7 %) 7 (0.09 %)
Hives 3 2 (3.1 %) 3 (0.04 %)
Flushing 3 2 (3.1 %) 4 (0.05 %)
Fever 2 2 (3.1 %) 2 (0.03 %)
Shaking 2 2 (3.1%) 1 (0.01%)
Factor IX inhibitor 2 1 1 (1.5 %) 2 (0.03 %)
Chest tightness 1 1 (1.5 %) 4 (0.05 %)
Drowsiness 1 1 (1.5 %) 1 (0.01 %)
Visual disturbance 1 1 (1.5 %) 1 (0.01 %)
Cellulitis at the IV site 1 1 (1.5 %) 7 (0.09 %)
Phlebitis at the IV site 1 1 (1.5 %) 7 (0.09 %)
Dry cough 1 1 (1.5 %) 0 (0.00 %)
Allergic reaction 1 1 (1.5 %) 1 (0.01 %)
Diarrhea 1 1 (1.5 %) 1 (0.01 %)
Lung disorder 1 1 (1.5 %) 1 (0.01 %)
Vomiting 1 1 (1.5 %) 1 (0.01 %)
Renal infarct3 1 1 (1.5 %) 1 (0.01 %)
Total 131 27/65 (41.5 %) 148/7573 (2.2 %)
*More than one event in the table could have been assoc. with an infusion; however, the total represents the actual number of infusions given.
1 Reaction occurring within 72 hours after infusion.
2 Low titer transient inhibitor formation.
3 The renal infarct developed in a hepatitis C antibody positive patient 12 days after a dose of BeneFIX® (coagulation factor ix recombinant) for a bleeding episode. The relationship of the infarct to the prior administration of BeneFIX® (coagulation factor ix recombinant) is uncertain.

One subject discontinued BeneFIX® (coagulation factor ix recombinant) due to pulmonary allergic-type symptoms.

In the 63 treated PUPS, who received a total of 5538 infusions, 22 adverse reactions were reported as having definite, probable, possible or unknown relationship to BeneFIX® (coagulation factor ix recombinant) . These events are summarized in Table 2 below.

Table 2: Adverse Events reported for PUPs*

Reaction Total number of events with definite, probable, possible or unknown relation to therapy
(n=22)
Number and (%) of patients from which the reports originated
(n=63)
Number and (%) of infusions temporally associated with there action1
(n=5538)
Diarrhea 5 1 (1.6 %) 11 (0.20%)
Urticaria (hives) 3 3 (4.8 %) 3 (0.05%)
Factor IX inhibitor2 2 2 (3.2%) 4 (0.07%)
Dyspnea (Respiratory distress) 2 2 (3.2 %) 2 (0.04%)
Increased alkaline phosphatase 1 1 (1.6 %) 3 (0.05%)
Elevated ALT 1 1 (1.6 %) 0 (0.00 %)
Rash (Body rash) 1 1 (1.6 %) 1 (0.02%)
Elevated AST 1 1 (1.6 %) 0 (0.00 %)
Chills (Rigors) 1 1 (1.6 %) 3 (0.05%)
Photosensitivity reaction 1 1 (1.6 %) 0 (0.00 %)
Injection site reaction 1 1 (1.6%) 2 (0.04%)
HAV seroconversion3 1 1 (1.6 %) 2 (0.04%)
Parvovirus B19 seroconversion4 1 1 (1.6%) 1 (0.02%)
Asthma 1 1 (1.6 %) 1 (0.02%)
Total 22 11/63 (17.5%) 27/5538 (0.60%)
*More than one event in the table could have been assoc. with an infusion; however, the total represents the actual number of infusions given.
1Reaction occurring within 72 hours after infusion.
2Two subjects developed high titer inhibitor formation during treatment with BeneFIX® (coagulation factor ix recombinant) .
3 Relationship of HAV seroconversion to BeneFIX® (coagulation factor ix recombinant) is unknown. HAV seroconversion was noted on 2 occasions in a single patient but was negative at final visit. The patient had no laboratory or clinical findings associated with active infection.
4Relationship of Parvovirus B19 seroconversion to BeneFIX® (coagulation factor ix recombinant) is unknown. It was unlikely that seroconversion was related to BeneFIX® (coagulation factor ix recombinant) due to the frequency of community acquired infection and viral safeguards built into the manufacturing process (See DESCRIPTION).

If any adverse reaction takes place that is thought to be related to the administration of BeneFIX® (coagulation factor ix recombinant) , the rate of infusion should be decreased or the infusion stopped.

Post-marketing Experience

The following post-marketing adverse reactions have been reported for BeneFIX® (coagulation factor ix recombinant) , as well as for plasma-derived factor IX products: inadequate factor IX recovery, inadequate therapeutic response, inhibitor development (see CLINICAL PHARMACOLOGY), anaphylaxis (see WARNINGS), laryngeal edema, angioedema, cyanosis, dyspnea, hypotension, and thrombosis.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The safety and efficacy of BeneFIX® (coagulation factor ix recombinant) administration by continuous infusion have not been established (see WARNINGS). There have been post-marketing reports of thrombotic events including life-threatening SVC syndrome in critically ill neonates, while receiving continuousinfusion BeneFIX® (coagulation factor ix recombinant) through a central venous catheter. Cases of peripheral thrombophlebitis and DVT have also been reported. In some, BeneFIX (coagulation factor ix recombinant) was administered via continuous infusion, which is not an approved method of administration (See Instruction For Use, Administration).

Read the Benefix (coagulation factor ix recombinant) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No information provided.

Last reviewed on RxList: 9/18/2008
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

The safety and efficacy of BeneFIX® (coagulation factor ix recombinant) administration by continuous infusion have not been established (see DOSAGE AND ADMINISTRATION and Instruction For Use, Administration). There have been post-marketing reports of thrombotic events in patients receiving continuous-infusion BeneFIX® (coagulation factor ix recombinant) through a central venous catheter, including life-threatening superior vena cava (SVC) syndrome in critically ill neonates (see ADVERSE REACTIONS, Post-marketing Experience section).

Factor IX complex concentrates have historically been associated with the development of thromboembolic complications.1 The use of factor IX-containing products, including BeneFIX® (coagulation factor ix recombinant) , may be potentially hazardous in patients at risk of thromboembolic phenomena, including patients with signs of fibrinolysis or disseminated intravascular coagulation (DIC), patients with liver disease or post-surgical patients.

Nephrotic syndrome has been reported following immune tolerance induction with factor IX products in hemophilia B patients with factor IX inhibitors and a history of allergic reactions to factor IX. The safety and efficacy of using BeneFIX® (coagulation factor ix recombinant) for immune tolerance induction have not been established.

Allergic type hypersensitivity reactions, including anaphylaxis, have been reported with factor IX products including BeneFIX® (coagulation factor ix recombinant) . Frequently, these events have occurred in close temporal association with the development of factor IX inhibitors. Patients should be informed of the early symptoms and signs of hypersensitivity reactions including hives, generalized urticaria, angioedema, chest tightness, dyspnea, wheezing, faintness, hypotension, tachycardia, and anaphylaxis. Patients should be advised to discontinue use of the product and contact their physician and/or seek immediate emergency care, depending on the type/severity of the reaction, if any of these symptoms occur (see PRECAUTIONS).

The diluent vial accompanying this product may contain dry natural rubber that may cause hypersensitivity reactions when handled by or administered to persons with known or possible latex sensitivity.

PRECAUTIONS

General

Activity-neutralizing antibodies (inhibitors) have been detected in patients receiving factor IXcontaining products. As with all factor IX products, patients using BeneFIX® (coagulation factor ix recombinant) should be monitored for the development of factor IX inhibitors (see CLINICAL PHARMACOLOGY and WARNINGS). Patients with factor IX inhibitors may be at an increased risk of anaphylaxis upon subsequent challenge with factor IX.2 Patients experiencing allergic reactions should be evaluated for the presence of inhibitor. Preliminary information suggests a relationship may exist between the presence of major deletion mutations in a patient's factor IX gene and an increased risk of inhibitor formation and of acute hypersensitivity reactions. Patients known to have major deletion mutations of the factor IX gene should be observed closely for signs and symptoms of acute hypersensitivity reactions, particularly during the early phases of initial exposure to product. In view of the potential for allergic reactions with factor IX concentrates, the initial (approximately 10 - 20) administrations of factor IX should be performed under medical supervision where proper medical care for allergic reactions could be provided.

Dosing of BeneFIX® (coagulation factor ix recombinant) may differ from that of plasma-derived factor IX products (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).

Carcinogenesis, Mutagenesis, Impairment of Fertility

BeneFIX (coagulation factor ix recombinant) ®, Coagulation Factor IX (Recombinant), has been shown to be nonmutagenic in the Ames assay and non-clastogenic in a chromosomal aberrations assay. No investigations on carcinogenesis or impairment of fertility have been conducted.

Pregnancy Category C

Animal reproduction and lactation studies have not been conducted with BeneFIX®, Coagulation Factor IX (Recombinant). It is not known whether BeneFIX® (coagulation factor ix recombinant) can affect reproductive capacity or cause fetal harm when given to pregnant women. BeneFIX® (coagulation factor ix recombinant) should be administered to pregnant and lactating women only if clearly indicated.

Pediatric Use

Additional safety and efficacy studies are ongoing in previously treated, minimally treated, and previously untreated pediatric patients (see CLINICAL PHARMACOLOGY, WARNINGS and DOSAGE AND ADMINISTRATION).

Data from BeneFIX (coagulation factor ix recombinant) R safety, efficacy, and pharmacokinetic studies have been evaluated in previously treated and previously untreated pediatric patients.

Nineteen (19) previously treated pediatric patients (range 4 to ≤ 15 years) underwent pharmacokinetic evaluations for up to 24 months. The mean increase in circulating factor IX activity was 0.7 ± 0.2 IU/dL per IU/kg infused (range 0.3 to 1.1 IU/dL per IU/kg; median of 0.6 IU/dL per IU/kg). The mean biological half-life was 20.2 ± 4.0 hours (range 14 to 28 hours).

Fifty-eight previously untreated patients [PUPs] less than 15 years of age at baseline [3 neonates (0-<1 month), 45 infants ( ≥ 1 month-<2 years), 9 children ( ≥ 2 years-<12 years) and 1 adolescent (>12 years)] underwent at least one recovery assessment within 30 minutes post-infusion in the presence or absence of hemorrhage during the study. The mean increase in circulating FIX activity was 0.7 ± 0.3 IU/dL per IU/kg infused (range 0.2 to 2.1 IU/dL per IU/kg; median of 0.6 IU/dL per IU/kg). In addition, there was no difference in the recoveries noted when data were evaluated by age group for infants (0.7 ± 0.4 IU/dL per IU/kg; range 0.2 to 2.1 IU/dL per IU/kg) and children (0.7 ± 0.2 IU/dL per IU/kg; range 0.2 to 1.5 IU/dL per IU/kg). The recoveries in these age groups were consistent with the recovery for the PUP study as a whole. There was insufficient sample size in the neonate and adolescent age groups to perform an analysis in these groups. Data from 57 subjects who underwent repeat recovery testing for up to 60 months demonstrated that the average incremental FIX recovery was consistent over time.

Geriatric Use

Clinical studies of BeneFIX (coagulation factor ix recombinant) R did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. As with any patient receiving BeneFIX (coagulation factor ix recombinant) R, dose selection for an elderly patient should be individualized (see DOSAGE AND ADMINISTRATION).

REFERENCES

1. Lusher JM. Thrombogenicity associated with factor IX complex concentrates. Semin Hematol. 1991;28(3 Suppl. 6):3-5.

2. Shapiro AD, Ragni MV, Lusher JM, et al. Safety and efficacy of monoclonal antibody purified factor IX concentrate in previously untreated patients with hemophilia B. Thromb Haemost. 1996;75(1):30-35.

Last reviewed on RxList: 9/18/2008
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

No information provided.

CONTRAINDICATIONS

Because BeneFIX®, Coagulation Factor IX (Recombinant), is produced in a Chinese hamster ovary cell line, it may be contraindicated in patients with a known history of hypersensitivity to hamster protein.

Last reviewed on RxList: 9/18/2008
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Factor IX is activated by factor VII/tissue factor complex in the extrinsic coagulation pathway as well as by factor XIa in the intrinsic coagulation pathway. Activated factor IX, in combination with activated factor VIII, activates factor X. This results ultimately in the conversion of prothrombin to thrombin. Thrombin then converts fibrinogen to fibrin, and a clot can be formed.

Factor IX is the specific clotting factor deficient in patients with hemophilia B. The administration of BeneFIX (coagulation factor ix recombinant) ®, Coagulation Factor IX (Recombinant), increases plasma levels of factor IX and can temporarily correct the coagulation defect in these patients.

After single intravenous (IV) doses of 50 IU/kg of BeneFIX®, Coagulation Factor IX (Recombinant), in 37 previously treated adult patients (>15 years), each given as a 10-minute infusion, the mean increase from pre-infusion level in circulating factor IX activity was 0.8 ± 0.2 IU/dL per IU/kg infused (range 0.4 to 1.4 IU/dL per IU/kg) and the mean biologic halflife was 18.8 ± 5.4 hours (range 11 to 36 hours). In the randomized, cross-over pharmacokinetic study in previously treated patients (PTPs), the in vivo recovery using BeneFIX® (coagulation factor ix recombinant) was statistically significantly less (28% lower) than the recovery using a highly purified plasma-derived factor IX product. There was no significant difference in biological half-life. Structural differences of the BeneFIX® (coagulation factor ix recombinant) molecule compared with pdFIX were shown to contribute to the lower recovery. In subsequent evaluations for up to 24 months, the pharmacokinetic parameters were similar to the initial results.

For specific information regarding pediatric pharmacology, see PRECAUTIONS, Pediatric Use.

Clinical Studies

There are ongoing safety and efficacy studies of BeneFIX® (coagulation factor ix recombinant) in previously treated, previously untreated, and minimally treated patients.

In 4 clinical studies of BeneFIX® (coagulation factor ix recombinant) , a total of 128 subjects 56 previously treated patients [PTPs], 9 subjects participating only in the surgical study, and 63 previously untreated patients (PUPs) received more than 28 million IU administered over a period of up to 64 months. The studies included 121 HIV-negative and 7 HIV-positive subjects.

Fifty-six PTPs received approximately 20.9 million IU of BeneFIX® (coagulation factor ix recombinant) in two clinical studies. The median number of exposure days was 83.5. These PTPs who were treated for bleeding episodes on an on-demand basis or for the prevention of bleeds were followed over a median interval of 24 months (range 1 to 29 months; mean 23.4 ± 5.34 months). Fifty-five of these PTPs received a median of 42.8 IU/kg (range 6.5 to 224.6 IU/kg; mean 46.6 ± 23.5 IU/kg) per infusion for bleeding episodes. All subjects were evaluable for efficacy. One subject discontinued the study after one month of treatment due to bleeding episodes that were difficult to control; he did not have a detectable inhibitor. The subject's dose had not been adequately titrated. The remaining 55 subjects were treated successfully. Bleeding episodes that were managed successfully included hemarthroses and bleeding in soft tissue and muscle. Data concerning the severity of bleeding episodes were not reported. Eighty-eight percent of the total infusions administered for bleeding episodes were rated as providing an "excellent" or "good" response. Eighty-one percent of all bleeding episodes were managed with a single infusion of BeneFIX® (coagulation factor ix recombinant) . One subject developed a low titer, transient inhibitor (maximum titer 1.5 BU). This subject had previously received plasma-derived products without a history of inhibitor development. He was able to continue treatment with BeneFIX® (coagulation factor ix recombinant) with no anamnestic rise in inhibitor or anaphylaxis, however, increased frequency of BeneFIX® (coagulation factor ix recombinant) administration was required; subsequently the subject's factor IX inhibitor and its effect on the half-life of BeneFIX® (coagulation factor ix recombinant) resolved.

Forty-one of the subjects had measurements of fibrinopeptide A and prothrombin fragment 1 + 2 prior to infusion, 4 to 8 hours and then 24 hours following the infusion. Twenty-nine of the subjects had elevations in fibrinopeptide A with a maximum value of 35.3 nmol/L (22 of the 29 subjects had elevated baseline values). Ten of the subjects had elevated prothrombin fragment 1 + 2 with a maximum value of 1.82 nmol/L (3 of the 10 subjects had elevated baseline values).

A total of 20 PTPs were treated with BeneFIX® (coagulation factor ix recombinant) for secondary prophylaxis (the regular administration of FIX replacement therapy to prevent bleeding in patients who may have already demonstrated clinical evidence of hemophilic arthropathy or joint disease) at some regular interval during the study with a mean of 2.0 infusions per week. Nineteen subjects were administered BeneFIX® (coagulation factor ix recombinant) for routine secondary prophylaxis (at least twice weekly) for a total of 345 patient-months with a median follow-up period of 24 months per subject. The average dose used by these 19 subjects was 40.3 IU/kg, ranging from 13 to 78 IU/kg. One additional subject was treated weekly, using an average dose of 33.3 IU/kg, over a period of 21 months. Ninetythree percent of the responses were rated as "excellent" or "effective". These 20 PTPs received a total of 2985 infusions of BeneFIX® (coagulation factor ix recombinant) for routine prophylaxis. Seven of these PTPs experienced a total of 26 spontaneous bleeding episodes within 48 hours after an infusion.

Management of hemostasis was evaluated in the surgical setting. Thirty-six surgical procedures have been performed in 28 subjects. Thirteen (13) minor surgical procedures were performed in 12 subjects, including 7 dental procedures, 1 punch biopsy of the skin, 1 cyst removal, 1 male sterilization, 1 nevus ablation, and 2 ingrown toenail removals. Twenty-three (23) major surgical procedures were performed in 19 subjects including a liver transplant, splenectomy, 3 inguinal hernia repairs, 11 orthopedic procedures, a calf-debridement and 6 complicated dental extractions.

Twenty-three (23) subjects underwent 27 surgical procedures with a pulse-replacement regimen. The mean perioperative (preoperative and intraoperative) dose for these procedures was 85 ± 32.8 IU/kg (range 25-154.9 IU/kg). The mean total post-operative (inpatient and outpatient) dose was 63.1 ± 22.0 IU/kg (range 28.6-129.0).

Total BeneFIX® (coagulation factor ix recombinant) coverage during the surgical period for the major procedures ranged from 4230 to 385,800 IU. The pre-operative dose for the major procedures ranged from 75 to 155 IU/kg. Nine of the major surgical procedures were performed in 8 subjects using a continuous infusion regimen. Following pre-operative bolus doses (94.1 -144.5 IU/kg), continuous infusion of BeneFIX® (coagulation factor ix recombinant) was administered at a median rate of 6.7 IU/kg/hr (range of average rates: 4.3-8.6 IU/kg/hr; mean 6.4 ± 1.5 IU/kg/hr) for a median duration of 5 days (range 1-11 days; mean 4.9 ± 3.1). Six of the 8 subjects who had received continuous infusion of BeneFIX® (coagulation factor ix recombinant) in conjunction with major surgeries were switched over to intermittent pulse regimens at a median dose of 56.3 IU/kg (range 33.6-89.1 IU/kg; mean 57.8 ± 18.1 IU/kg SD) for a median of 3.5 exposure days (range 1-5 days, mean 3.3 ± 1.4 SD) during the post-operative period. Although circulating factor IX levels targeted to restore and maintain hemostasis were achieved with both pulse replacement and continuous infusion regimens, clinical trial experience with continuous infusion of BeneFIX® (coagulation factor ix recombinant) for surgical prophylaxis in hemophilia B has been too limited to establish the safety and clinical efficacy of administration of the product by continuous infusion. Subjects administered BeneFIX® (coagulation factor ix recombinant) by continuous infusion for surgical prophylaxis also received intermittent bolus infusions of the product.

Among the surgery subjects, the median increase in circulating factor IX activity was 0.7 IU/dL per IU/kg infused (range 0.3-1.2 IU/dL; mean 0.8 ± 0.2 IU/dL per IU/kg). The median elimination half-life for the surgery subjects was 19.4 hours (range 10-37 hours; mean 21.3 ± 8.1 hours).

Hemostasis was maintained throughout the surgical period, however, one subject required evacuation of a surgical wound site hematoma and another subject who received BeneFIX® (coagulation factor ix recombinant) after a tooth extraction required further surgical intervention due to oozing at the extraction site. There was no clinical evidence of thrombotic complications in any of the subjects. In seven subjects for whom fibrinopeptide A and prothrombin fragment 1 + 2 were measured pre-infusion, at 4 to 8 hours, and then daily up to 96 hours, there was no evidence of significant increase in coagulation activation. Data from two other subjects were judged to be not evaluable.

Sixty-three PUPs received approximately 6.2 million IU of BeneFIX® (coagulation factor ix recombinant) in an open-label safety and efficacy study over 89 median exposure days. These PUPs were followed over a median interval of 37 months (range 4 to 64 months; mean 38.1 ± 16.4 months). Fifty-four of these PUPs received a median dose of 62.7 IU/kg (range 8.2 to 292.0 IU/kg; mean 75.6 ± 42.5 IU/kg) per infusion for bleeding episodes. Data concerning the severity of bleeding episodes were not reported. Seventy-five percent of all bleeding episodes were managed with a single infusion of BeneFIX® (coagulation factor ix recombinant) . Three of these 54 subjects were not successfully treated; including one episode in a subject due to delayed time to infusion and insufficient dosing and in 2 subjects due to inhibitor formation. One subject developed a high titer inhibitor (maximum titer 42 BU) on exposure day 7. A second subject developed a high titer inhibitor (maximum titer 18 BU) after 15 exposure days. Both subjects experienced allergic manifestations in temporal association with their inhibitor development.

Thirty-two PUPs administered BeneFIX® (coagulation factor ix recombinant) for routine prophylaxis. Twenty-four PUPs administered BeneFIX® (coagulation factor ix recombinant) at least twice weekly for a total of 2587 infusions. The mean dose per infusion was 72.5 ± 37.1 IU/kg, and the mean duration of prophylaxis was 13.4 ± 8.2 months. Eight PUPs administered BeneFIX® (coagulation factor ix recombinant) once weekly for a total of 571 infusions. The mean dose per infusion was 75.9 ± 17.9 IU/kg, and the mean duration of prophylaxis was 17.6 ± 7.4 months. Five PUPs experienced a total of 6 spontaneous bleeding episodes within 48 hours after an infusion.

Twenty-three PUPs received BeneFIX® (coagulation factor ix recombinant) for surgical prophylaxis in 30 surgical procedures. All surgical procedures were minor except 2 hernia repairs. The preoperative bolus dose ranged from 32.3 IU/kg to 247.2 IU/kg. The perioperative total dose ranged from 385 to 23280 IU. Five of the surgical procedures were performed using a continuous infusion regimen over 3 to 5 days. Clinical trial experience with continuous infusion of BeneFIX® (coagulation factor ix recombinant) for surgical prophylaxis in hemophilia B has been too limited to establish the safety and clinical efficacy of administration of the product by continuous infusion.

Last reviewed on RxList: 9/18/2008
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

Patients should be informed of the early symptoms and signs of hypersensitivity reactions including hives, generalized urticaria, angioedema, chest tightness, dyspnea, wheezing, faintness, hypotension, tachycardia, and anaphylaxis. Patients should be advised to discontinue use of the product and contact their physician and/or seek immediate emergency care, depending on the type/severity of the reaction, if any of these symptoms occur. Patients experiencing allergic reactions should be evaluated for the presence of inhibitor.

Last reviewed on RxList: 9/18/2008
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

Patients should be informed of the early symptoms and signs of hypersensitivity reactions including hives, generalized urticaria, angioedema, chest tightness, dyspnea, wheezing, faintness, hypotension, tachycardia, and anaphylaxis. Patients should be advised to discontinue use of the product and contact their physician and/or seek immediate emergency care, depending on the type/severity of the reaction, if any of these symptoms occur. Patients experiencing allergic reactions should be evaluated for the presence of inhibitor.

Last reviewed on RxList: 9/18/2008
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Benefix 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.

FACTOR IX, HUMAN RECOMBINANT - INJECTION

(FACK-ter nine)

COMMON BRAND NAME(S): Benefix

USES: This medication is used to prevent or control bleeding in people with little or no factor IX (due to hemophilia B, Christmas disease). Factor IX is a protein (clotting factor) in the blood that works with other clotting factors to help the blood clot and therefore stop bleeding. People with little or no factor IX are at risk for bleeding longer after an injury/surgery or bleeding suddenly (often in the joints/muscle) without an obvious cause.

This medication should not be used to treat other types of factor deficiencies (e.g., factors II, VII, VIII, X) or factor problems (e.g., inhibitor to factor XIII), to reverse the effects of "blood thinners" (e.g., warfarin), or to treat bleeding from low levels of liver-dependent clotting factors (due to liver problems).

HOW TO USE: This medication is given by injection into a vein over several minutes as directed by your doctor. Dosage is based on your medical condition (e.g., amount and location of bleeding), weight, and response to treatment.

If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

When using this medication, it is important to limit the amount of blood entering the tubing and to avoid letting any blood enter the syringe. You may need to use a new vial of medication and new set of supplies if this occurs. Consult the pharmacist for details.

The medication in the vial and the supplies that come with the medication should be used only once. Do not reuse.

Tell your doctor if your condition persists or worsens.

Disclaimer

Benefix Consumer (continued)

SIDE EFFECTS: Fever, pain at injection site, chills, headache, flushing, weakness, nausea, or vomiting may occur. If any of these effects persist or worsen, tell 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.

Tell your doctor right away if you have any serious side effects, including: swelling at injection site, shortness of breath, fast heartbeat, change in the amount of urine, swelling of the ankles/feet, pain/redness/swelling of arms or legs, new or increased bleeding/bruising.

Get medical help right away if any of these rare but very serious side effects occur: bluish fingers, chest pain, trouble breathing.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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 Benefix (coagulation factor ix recombinant) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before using factor IX, tell your doctor or pharmacist if you are allergic to factor IX products; or to hamster protein; or if you have any other allergies. This product may contain inactive ingredients (such as latex), 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: other clotting disorders (e.g., disseminated intravascular coagulation-DIC), recent surgery/procedure, liver disease.

Before having surgery, tell your doctor or dentist that you are using this medication.

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

It is not known whether this medication passes into breast milk. Consult your doctor before breast-feeding.

Disclaimer

Benefix 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.

Some products that may interact with this drug include: drugs that help with clotting (e.g., tranexamic acid).

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.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (e.g., factor IX activity) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist immediately to establish a new dosing schedule. Do not double the dose to catch up.

STORAGE: Consult the product instructions and your pharmacist for storage details. Keep all medications 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.

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

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

Benefix Patient Information Including Side Effects

Brand Names: Alphanine SD, Benefix, Mononine

Generic Name: coagulation factor IX (Pronunciation: koh AG yoo LAY shun FAK tor)

What is coagulation factor IX (Benefix)?

Coagulation factor IX is a man-made protein that is similar to a natural protein in the body that helps the blood to clot.

Coagulation factor IX is used to treat or prevent bleeding in people with hemophilia B. This medication is not for treating people with hemophilia A factor VII deficiency.

Coagulation factor IX may also be used for purposes other than those listed here.

What are the possible side effects of coagulation factor IX (Benefix)?

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

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

  • fever or chills;
  • continued bleeding after treatment;
  • feeling like you might pass out;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance; or
  • swelling in your feet or ankles, weight gain, loss of appetite.

Less serious side effects may be more likely to occur, such as:

  • headache;
  • warmth, redness, or tingly feeling under your skin;
  • nausea, vomiting;
  • dizziness; or
  • pain, redness, or swelling where the medicine was injected.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the Benefix (coagulation factor ix recombinant) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about coagulation factor IX (Benefix)?

Do not use this medication if you have ever had an allergic reaction to a clotting factor medication, or if you are allergic to hamster proteins.

Before using this medication, tell your doctor if you are allergic to latex rubber, or if you have liver disease, coronary artery disease (hardening of the arteries), or a history of stroke or heart attack.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

Carry an ID card or wear a medical alert bracelet stating that you have a bleeding disorder in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know about your condition.

Side Effects Centers

Benefix Patient Information including How Should I Take

What should I discuss with my healthcare provider before using coagulation factor IX (Benefix)?

Do not use this medication if you have ever had an allergic reaction to a clotting factor medication, or if you are allergic to hamster proteins.

Before using this medication, tell your doctor if you are allergic to latex rubber, or if you have:

  • liver disease;
  • coronary artery disease (hardening of the arteries); or
  • history of stroke or heart attack.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether coagulation factor IX 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 coagulation factor IX (Benefix)?

Coagulation factor IX is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. You may be given instructions on how to use your injections at home.

Do not use this medicine at home if you do not fully understand how to give the injection and properly dispose of needles and other items used in giving the medicine.

Use each disposable needle only one time. Throw away used needles and syringes 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.

Coagulation factor IX is a powder medication that must be mixed with a liquid (diluent) before injecting it. Use the injection within 3 hours after mixing your dose.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

Carry an ID card or wear a medical alert bracelet stating that you have a bleeding disorder in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know about your condition.

If you store this medication at home, keep the powder medicine in the refrigerator. Do not freeze. Avoid exposing the medication to sunlight.

The diluent can be stored at room temperature. You may also coagulation factor IX powder at cool room temperature for up to 6 months.

Side Effects Centers

Benefix Patient Information including If I Miss a Dose

What happens if I miss a dose (Benefix)?

Contact your doctor if you miss a dose of this medication.

What happens if I overdose (Benefix)?

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of coagulation factor IX is not expected to produce life-threatening symptoms.

What should I avoid while using coagulation factor IX (Benefix)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using coagulation factor IX.

What other drugs will affect coagulation factor IX (Benefix)?

There may be other drugs that can interact with coagulation factor IX. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about coagulation factor IX.


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

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

Copyright 1996-2012 Cerner Multum, Inc. Version: 1.03. Revision date: 12/15/2010.

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

Healthwise

Side Effects Centers

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