Generic Name and Formulations:
Antihemophilic Factor (recombinant) single chain 250 IU, 500 IU, 1000 IU, 2000 IU, 3000 IU; per vial; lyophilized pwd for IV infusion after reconstitution; preservative-free.
CSL Behring, LLC
Indications for AFSTYLA:
In patients with Hemophilia A: to treat and control bleeding episodes, for perioperative management, and routine prophylaxis to reduce the frequency of bleeding episodes.
Limitations Of use:
Not for treating von Willebrand disease.
Adults and Children:
Dosage Required (IU) = Body Weight (kg) × Desired % Factor VIII Increase × 0.5. Individualize. Max infusion rate: 10mL/min. Bleeding: Minor: obtain 20–40% FVIII increase; may repeat every 12–24hrs until resolved; Moderate: obtain 30–60% FVIII increase; may repeat every 12–24hrs until resolved; Major: obtain 60–100% FVIII increase; may repeat every 8–24hrs until resolved. Perioperative: Minor: obtain 30–60% FVIII increase; may repeat every 24hrs for ≥1 day until healed; Major: obtain 80–100% FVIII increase; may repeat every 8–24hrs until adequately healed, then continue for ≥7 days to maintain Factor VIII activity of 30–60%. Routine prophylaxis: ≥12yrs: 20–50 IU/kg 2–3 times weekly; <12yrs: 30–50 IU/kg 2–3 times weekly (more frequent or higher doses may be required).
Hamster protein sensitivity.
Confirm Factor VIII deficiency prior to treatment. Monitor for development of Factor VIII inhibitors. Discontinue if hypersensitivity reactions occur; consider premedication with antihistamines if previous history of hypersensitivity. Pregnancy. Nursing mothers.
Dizziness, hypersensitivity, paresthesia, rash, erythema, pruritus, pyrexia, inj site pain, chills, feeling hot.
Kit—1 (vial w. diluent + supplies)