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1 X 250 IU
1 X 500 IU
1 X 1000 IU
1 X 2000 IU
General Considerations for Administration For Intravenous Use after Reconstitution:
– Treatment with BeneFIX, Coagulation Factor IX (Recombinant), should be initiated under the supervision of a physician experienced in the treatment of hemophilia B.
– Each vial of BeneFIX has the rFIX potency in the International Units (IU) stated on the vial.
– 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.
Dosing of BeneFIX may differ from that of plasma-derived factor IX products. Subjects at the low end of the observed factor IX recovery may require upward dosage adjustment of BeneFIX to as much as two times (2X) the initial empirically calculated dose in order to achieve the intended rise in circulating factor IX activity.
The safety and efficacy of BeneFIX administration by continuous infusion have
not been established.
For Method of Calculating Initial Estimated Dose: Please refer to table 1 at prescribing information.
For Dosing Guide for Control and Prevention of Bleeding Episodes and Perioperative Management: Please refer to table 4 at prescribing information.
See prescribing information for full details.
Control and Prevention of Bleeding Episodes in Hemophilia B: BeneFIX®, Coagulation Factor IX (Recombinant), is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with hemophilia B (congenital factor IX deficiency or Christmas disease).
Peri-operative Management in Patients with Hemophilia B: BeneFIX, Coagulation Factor IX (Recombinant), is indicated for peri-operative management in adult and pediatric patients with hemophilia B.
BeneFIX, Coagulation Factor IX (Recombinant), is NOT indicated for:
a. treatment of other factor deficiencies (e.g., factors II, VII, VIII, and X),
b. treatment of hemophilia A patients with inhibitors to factor VIII,
c. reversal of coumarin-induced anticoagulation,
d. treatment of bleeding due to low levels of liver-dependent coagulation factors.
Patients who have manifested life-threatening, immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster protein.
Hypersensitivity Reactions: Hypersensitivity reactions, including anaphylaxis, have been reported with BeneFIX and have manifested as pruritus, rash, urticaria, hives, facial swelling, dizziness, hypotension, nausea, chest discomfort, cough, dyspnea, wheezing, flushing, discomfort (generalized) and fatigue.
Frequently, these events have occurred in close temporal association with the development of factor IX inhibitors.
Closely monitor patients for signs and symptoms of acute hypersensitivity reactions, particularly during the early phases of initial exposure to product. Because of the potential for allergic reactions with factor IX concentrates, perform the initial (approximately 10 – 20) administrations of factor IX under medical supervision where proper medical care for allergic reactions could be
provided. Advise patients to discontinue use of the product and contact their physician and/or seek immediate emergency care. Immediately discontinue the administration and initiate appropriate treatment if symptoms occur.
BeneFIX contains trace amounts of hamster (CHO) proteins. Patients treated with this product may develop hypersensitivity to these non-human mammalian proteins.
Thromboembolic Complications: There have been post-marketing reports of thrombotic events in patients receiving continuousinfusion BeneFIX through a central venous catheter, including life-threatening superior vena cava (SVC) syndrome in critically ill neonates. The safety and efficacy of BeneFIX administration by continuous infusion have not been established.
Nephrotic Syndrome: 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 for immune tolerance induction have not been established.
Neutralizing Antibodies (Inhibitors): Neutralizing antibodies (inhibitors) have been reported following administration of BeneFIX. Evaluate patients using BeneFIX for the development of factor IX inhibitors by appropriate clinical observations and laboratory tests. If expected plasma factor IX activity levels are not attained, or if bleeding is not controlled with an expected dose, perform an assay that measures factor IX inhibitor concentration.
Patients with factor IX inhibitors are at an increased risk of severe hypersensitivity reactions or anaphylaxis upon subsequent challenge with factor IX. Evaluate patients experiencing allergic reactions for the presence of an inhibitor and closely monitor patients with inhibitors for signs and symptoms of acute hypersensitivity reactions, particularly during the early phases of initial exposure to product.
Monitoring Laboratory Tests:
– Monitor patients for factor IX activity levels by the one-stage clotting assay to confirm that adequate factor IX levels have been achieved and maintained, when clinically indicated.
-Monitor patients for the development of inhibitors if expected plasma factor IX activity levels are not attained, or if bleeding is not controlled with the recommended dose of BeneFIX. Determine plasma factor IX inhibitor levels in Bethesda Units (BUs).
The most serious adverse reactions are systemic hypersensitivity reactions, including bronchospastic reactions and/or hypotension and anaphylaxis and the development of hightiter inhibitors necessitating alternative treatments to factor IX replacement therapy.
The most common adverse reactions observed in clinical trials ([frequency > 5% of previously treated patients (PTPs) or previously untreated patients ( PUPs)] were fever, cough headaches, dizziness, nausea, injections site reaction, injection site pain and skin- related hypersensitivity reactions (e.g., rash, hives). See prescribing information for full details.
Pregnancy and Lactation
Pregnancy: Coagulation Factor IX (Recombinant) should be administered to pregnant and lactating women only if needed.
Lactation: It is not known whether this drug is excreted into human milk. Because many drugs are excreted into human milk, caution should be exercised if it is administered to nursing mothers. Use only if needed.
Product after reconstitution: The product does not contain a preservative and should be used within 3 hours.