Data from FDA - Curated by Toby Galbraith - Last updated 19 May 2017

Licensing authority

FDA (Food and Drug Administration, USA)

Indication(s)

ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is a human antihemophilic factor indicated in children and adults with hemophilia A (congenital factor VIII deficiency) for:
• On-demand treatment and control of bleeding episodes
• Perioperative management
• Routine prophylaxis to reduce the frequency of bleeding episodes

Limitation of Use
ADYNOVATE is not indicated for the treatment of von Willebrand disease. (1)

Full Prescribing information

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Advisory information

contraindications

Do not use in patients who have had prior anaphylactic reaction to ADYNOVATE, the parent molecule (ADVATE), mouse or hamster protein, or excipients of ADYNOVATE. (4)

Special warnings and precautions

• Hypersensitivity reactions, including anaphylaxis, are possible. Should symptoms occur, discontinue treatment with ADYNOVATE and administer appropriate treatment. (5.1)
• Development of factor VIII neutralizing antibodies (inhibitors) may occur. If expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an appropriate dose, perform an assay that measures factor VIII inhibitor concentration. (5.2, 5.3)

Adverse reactions

The most common adverse reactions reported in ≥1% of subjects in the clinical studies were headache and nausea. (6)

Usage information

Dosing and administration

For intravenous use after reconstitution only
• One unit per kilogram body weight will raise the factor VIII level by 2% international units per deciliter (IU per dL). Each vial of ADYNOVATE is labeled with the actual amount of recombinant factor VIII present in IU. (2.1)

• On-demand treatment and control of bleeding episodes and perioperative management:
- Estimated Increment of factor VIII (IU/dL or % of normal) = [Total Dose (IU)/body weight (kg)] x 2 (IU/dL per IU/kg)
- Dose (IU) = Body Weight (kg) x Desired factor VIII Rise (IU/dL or % of Normal) x 0.5 (IU/kg per IU/dL)

• Routine prophylaxis: Administer 40-50 IU per kg body weight 2 times a week (Starting dose of 55 IU per kg body weight 2 times a week patients <12 years of age with a maximum of 70 IU per kg).

• Inject intravenously over a period of less than or equal to 5 minutes (maximum infusion rate 10 mL per min). (2.3)

Use in special populations
Pediatric Use: Higher clearance, a shorter half-life and lower incremental recovery of factor VIII has been observed in children (<12 years). Dose adjustment or more frequent dosing based on per kg body weight may be needed in this population.

More information

Category Value
Authorisation number BLA125566
Orphan designation No
Product NDC 0944-4252; 0944-4254; 0944-4256; 0944-4258; 0944-4260; 0944-4262; 0944-4623; 0944-4624; 0944-4625; 0944-4626; 0944-4627
Date First Approved 13-11-2015
Marketing authorisation holder Baxalta US Inc.