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Afstyla Generic Name & Formulations
Legal Class
Rx
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)
Manufacturer
Generic Availability
NO
Afstyla Indications
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
Contraindications
Hamster protein sensitivity.
Afstyla Boxed Warnings
Not Applicable
Afstyla Warnings/Precautions
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
