Bleeding disorders:
Indications for BENEFIX:
Prevention and control of bleeding in hemophilia B. Peri-operative management in patients with hemophilia B.
Adults and Children:
See full labeling. Initial Dose Required (IU) = Body Weight (kg) x Desired FIX increase x Reciprocal of observed recovery (IU/kg per IU/dL). Average recovery (≥15yrs): Dose Required (IU) = Body Weight (kg) x Desired FIX increase x 1.3 (IU/kg per IU/dL); (<15yrs): Dose Required (IU) = Body Weight (kg) x Desired FIX increase x 1.4 (IU/kg per IU/dL). Give by IV infusion over several minutes. If inhibitor present or low factor IX recovery, may need higher doses. Hemorrhage (Minor): 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 12–24hrs for 7–10 days.
BENEFIX Contraindications:
Hamster protein hypersensitivity.
BENEFIX Warnings/Precautions:
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. Labor & delivery. Pregnancy. Nursing mothers.
BENEFIX Classification:
Clotting factor.
Adverse Reactions:
Nausea, inj site reaction/pain, headache, dizziness, rash; hypersensitivity reactions, inhibitor development, thrombosis.
How Supplied:
Single-use vials—1 (w. diluent, supplies)
