Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 07 May 2018
• Development of activity-neutralizing antibodies can occur in patients receiving factor VIII-containing products, including Kogenate FS. If expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an expected dose, perform an assay that measures factor VIII inhibitor concentration (5.2).
• Monitor plasma factor VIII levels during infusions when indicated (5.3).
• When clotting is normalized by treatment with factor VIII, development of cardiovascular risk factors may be the same as the risk for nonhemophilic patients (5.4).
The most common adverse reactions (≥4%) in clinical trials are inhibitor formation (neutralizing antibodies) in previously untreated and minimally treated patients (PUPs and MTPs), skin-associated hypersensitivity reactions (e.g., rash, pruritus, urticaria), infusion site reactions (e.g., inflammation, pain), and central venous access device (CVAD) associated infections.
• Each vial of Kogenate FS contains the labeled amount of recombinant factor VIII in international units (IU, unit).
Control and prevention of bleeding episodes and peri-operative management (2.1):
• Dose (units) = body weight (kg) x desired factor VIII rise (IU/dL or % of normal) x 0.5 (IU/kg per IU/dL).
• Titrate doses to patient’s clinical response.
• Determine treatment frequency based on type of bleeding episode.
For routine prophylaxis in adults: 25 units per kg three times a week (2.1).
For routine prophylaxis in children: 25 units per kg every other day (2.1).
• Pediatric Use: Higher factor VIII clearance may occur in children (4.4– 16 years). Dose adjustment may be needed (8.4).
|Product NDC||0026-3782; 0026-3783; 0026-3785; 0026-3786; 0026-3787; 0026-3792; 0026-3793; 0026-3795; 0026-3796; 0026-3797|
|Date First Approved||26-06-2000|
|Marketing authorisation holder||Bayer HealthCare LLC|