Data from FDA - Curated by Toby Galbraith - Last updated 19 May 2017
FDA (Food and Drug Administration, USA)
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).
• 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).
The most frequently reported adverse reactions in clinical trials (≥3%) were headache, pyrexia, and pruritus (6).
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.
|Product NDC||0026-3821; 0026-3822; 0026-3824; 0026-3826; 0026-3828|
|Date First Approved||17-03-2016|
|Marketing authorisation holder||Bayer HealthCare, LLC|