Generic Name and Formulations:
Coagulation Factor IX (recombinant) 250 IU, 500 IU, 1000 IU, 2000 IU; per vial; lyophilized pwd for IV infusion after reconstitution; preservative-free.
Prevention and control of bleeding in hemophilia B. Peri-operative management in patients with hemophilia B.
Dosage Required (IU) = Body Weight (kg) x Desired Factor IX increase x 1.3 IU/kg. 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.
<15yrs: See literature. Dose (IU) = body weight (kg) x % FIX increase x 1.4 IU/kg.
Hamster protein hypersensitivity.
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).
Headache, fever, chills, flushing, GI upset, lethargy, taste perversion, hypoxia, inj site reactions, dizziness, allergic rhinitis; hypersensitivity reactions, inhibitor development, thrombosis.
Single-use vials—1 (w. diluent, supplies)
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