• Bleeding disorders

Afstyla Generic Name & Formulations

General Description

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.

Pharmacological Class

Clotting factor.

How Supplied

Kit—1 (vial w. diluent + supplies)


Generic Availability


Afstyla Indications


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.

Afstyla Dosage and Administration

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).

Afstyla Contraindications


Hamster protein sensitivity.

Afstyla Boxed Warnings

Not Applicable

Afstyla Warnings/Precautions


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.

Afstyla Pharmacokinetics

See Literature

Afstyla Interactions

Not Applicable

Afstyla Adverse Reactions

Adverse Reactions

Dizziness, hypersensitivity, paresthesia, rash, erythema, pruritus, pyrexia, inj site pain, chills, feeling hot.

Afstyla Clinical Trials

See Literature

Afstyla Note

Not Applicable

Afstyla Patient Counseling

See Literature