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ADYNOVATE
Bleeding disorders
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Drug Name:

ADYNOVATE Rx

Generic Name and Formulations:
Antihemophilic Factor VIII (recombinant) 250 IU, 500 IU, 750 IU, 1000 IU, 2000 IU; per vial; PEGylated lyophilized pwd for IV inj after reconstitution; preservative-free.

Company:
Baxalta

Therapeutic Use:

Indications for ADYNOVATE:

In patients with Hemophilia A: for on-demand treatment and control of bleeding episodes, 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 (IU/dL or % of Normal) × 0.5 (IU/kg per IU/dL). Infuse over ≤5 minutes (max infusion rate 10mL/min). Bleeding (Minor): obtain 20–40% FVIII increase; give every 12–24hrs until resolved; (Moderate): obtain 30–60% FVIII increase; give every 12–24hrs until resolved; (Major): obtain 60–100% FVIII increase; give every 8–24hrs until resolved. Perioperative (Minor surgery): obtain 60–100% FVIII increase; give 1hr before surgery; repeat after 24hrs if needed until bleeding resolved; (Major surgery): obtain 80–120% FVIII increase (pre- and post-op); give 1hr before surgery; repeat every 8–24hrs (6–24hrs if <12yrs) until adequate wound healing. Routine prophylaxis: ≥12yrs: give 40–50 IU/kg twice weekly; <12yrs: 55 IU/kg twice weekly; max 70 IU/kg. Adjust based on response.

Contraindications:

Prior anaphylactic reaction to Advate. Mouse or hamster protein sensitivity.

Warnings/Precautions:

Monitor for development of Factor VIII inhibitors. Immediately discontinue if hypersensitivity reactions occur. Pregnancy. Nursing mothers.

Pharmacological Class:

Clotting factor.

Adverse Reactions:

Headache, nausea, diarrhea, flushing; antibody formation.

Generic Availability:

NO

How Supplied:

Single-dose vial—1 (w. diluent, Baxject II needleless transfer device)

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