Data from FDA (Food and Drug Administration, USA) - Curated by Marshall Pearce - Last updated 19 May 2017

Indication(s)

KOVALTRY, Antihemophilic Factor (Recombinant), is a recombinant, human DNA sequence derived, full length Factor VIII concentrate indicated for use in adults and children with hemophilia A (congenital Factor VIII deficiency) for:
• On-demand treatment and control of bleeding episodes
• Perioperative management of bleeding
• Routine prophylaxis to reduce the frequency of bleeding episodes

KOVALTRY 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 history of hypersensitivity reactions to the active substance, mouse or hamster protein, or other constituents of the product (4).

Special warnings and precautions

• Hypersensitivity reactions, including anaphylaxis, are possible. Should symptoms occur, discontinue treatment with KOVALTRY and administer appropriate treatment (5.1).
• Development of Factor VIII neutralizing antibodies can occur. Perform an assay that measures Factor VIII inhibitor concentration if expected plasma Factor VIII activity levels are not attained, or if bleeding is not controlled as expected with administered dose (5.2, 5.5).

Adverse reactions

The most frequently reported adverse reactions in clinical trials (≥3%) were headache, pyrexia, and pruritus (6).

Usage information

Dosing and administration
For intravenous use after reconstitution only.

Control of bleeding episodes and perioperative management (2.1)
• Required dose (IU) = body weight (kg) x desired Factor VIII rise (% of normal or IU/dL) x reciprocal of expected/observed recovery (e.g., 0.5 for a recovery of 2 IU/dL per IU/kg).
• Estimated Increment of Factor VIII (IU/dL or % of normal) = [Total Dose (IU)/body weight (kg)] x 2 (IU/dL per IU/kg).

Routine prophylaxis (2.1)
• Adults and adolescents: 20-40 IU/kg 2 or 3 times per week.
• Children ≤12 years old: 25-50 IU/kg 2 times per week, 3 times per week or every other day.
Use in special populations
Pediatric Use: Due to higher clearance (body weight adjusted) in children ≤12 years of age, higher or more frequent dosing may be needed (8.4).

More information

Category Value
Authorisation number BLA125574
Orphan designation No
Product NDC 0026-3821; 0026-3822; 0026-3824; 0026-3826; 0026-3828
Date First Approved 17-03-2016
Marketing authorisation holder Bayer HealthCare, LLC