HELIXATE FS Rx
Generic Name and Formulations:
Antihemophilic Factor VIII (recombinant) 250 IU, 500 IU, 1000 IU; per bottle; dried concentrate for IV infusion after reconstitution; contains sucrose; preservative-free.
CSL Behring, LLC
Indications for HELIXATE FS:
Prevention and control of hemorrhagic episodes or in order to perform emergency or elective surgery in Hemophilia A patients.
Adults and Children:
Dosage Required (IU) = Body Weight (kg) × Desired % Factor VIII Increase × 0.5. Individualize. Infuse over 5–10minutes if tolerated. Minor hemorrhage: 10–20 IU/kg; may repeat dose if needed. Moderate/major hemorrhage or minor surgery: 15–30 IU/kg; may repeat 1 dose at 12–24hrs if needed. Major/life-threatening hemorrhage, fractures or head trauma: initially 40–50 IU/kg, then 20–25 IU/kg every 8–12hrs. Major surgery: pre-op dose: 50 IU/kg (verify ~100% activity prior to surgery); may repeat after 6–12hrs initially, and for 10–14 days until completely healed.
Mouse or hamster protein sensitivity.
Not for treating von Willebrand's disease. Confirm Factor VIII deficiency prior to treatment. Monitor for development of Factor VIII inhibitors. Pregnancy (Cat.C). Nursing mothers.
Inj site reactions, dizziness, rash, dysgeusia, increased BP, pruritus, depersonalization, GI upset, rhinitis; antibody formation, hypersensitivity reactions.
Single-use bottle—1 (w. diluent)