• Bleeding disorders

Adynovate Generic Name & Formulations

General Description

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.

Pharmacological Class

Clotting factor.

How Supplied

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

Generic Availability


Adynovate Indications


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.

Adynovate Dosage and Administration

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.

Adynovate Contraindications


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

Adynovate Boxed Warnings

Not Applicable

Adynovate Warnings/Precautions


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

Adynovate Pharmacokinetics

See Literature

Adynovate Interactions

Not Applicable

Adynovate Adverse Reactions

Adverse Reactions

Headache, nausea, diarrhea, flushing; antibody formation.

Adynovate Clinical Trials

See Literature

Adynovate Note

Not Applicable

Adynovate Patient Counseling

See Literature