Monograph Details
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Hematology
> Bleeding disorders
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BENEFIX |
| Manufacturer |
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Wyeth Pharmaceuticals |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Clotting factor. |
| Generic Name |
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Coagulation Factor IX (recombinant) 250 IU, 500 IU, 1000 IU; per vial; lyophilized pwd for IV infusion after reconstitution; preservative-free. |
| Indications |
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Prevention and control of bleeding in Hemophilia B. |
| Children |
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<15yrs: See literature. Dose (IU)= body weight (kg) x % FIX increase x 1.4 IU/kg. |
| Adults |
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See prescribing note for dosing equation. Give by IV infusion over several minutes. If inhibitor present or low Factor IX recovery, may need higher doses. Minor hemorrhage: 20–30% increase every 12–24hrs for 1–2 days. Moderate: 25–50% increase every 12–24hrs for 2–7 days until resolved. Major: 50–100% increase every 12–24 hrs for 7–10 days. |
| Contraindications |
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Hamster protein hypersensitivity. |
| Precautions |
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Not for Hemophilia A with FVIII inhibitors or other factor deficiencies, reversal of coumarin-induced anticoagulation or for low levels of liver-dependant coagulation factors. Fibrinolysis, disseminated intravascular coagulation (DIC), liver disease, neonates, or during post-op period; increased risk of thromboembolic events. Monitor for Factor IX inhibitors and deletion mutations of Factor IX gene; increased risk of anaphylaxis. Immune tolerance induction. Latex allergy. Pregnancy (Cat.C). |
| Adverse Reactions |
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Headache, fever, chills, flushing, GI upset, lethargy, taste perversion, hypoxia, inj site reactions, dizziness, allergic rhinitis; hypersensitivity reactions, inhibitor development, thrombosis. |
| How Supplied |
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Single-use vials—1 (w. diluent, supplies) |
| Additional Resources |
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• Related Prescribing Note |
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