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AFSTYLA
Bleeding disorders
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Drug Name:

AFSTYLA Rx

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.

Company:
CSL Behring, LLC

Therapeutic Use:

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).

Contraindications:

Hamster protein sensitivity.

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.

Pharmacological Class:

Clotting factor.

Adverse Reactions:

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

Generic Availability:

NO

How Supplied:

Kit—1 (vial w. diluent + supplies)

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