FDA (Food and Drug Administration, USA)
• Hypersensitivity reactions, including anaphylaxis, are possible. Should symptoms occur, immediately discontinue ELOCTATE and initiate 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)
The most frequently occurring adverse reactions (>0.5% of subjects) in clinical trials were arthralgia, malaise, myalgia, headache, and rash. (6)
For intravenous use after reconstitution only.
• Each vial of ELOCTATE is labeled with the amount of recombinant Factor VIII in international units (IU or unit). One unit per kilogram body weight will raise the Factor VIII level by 2% IU/dL. (2.1)
• For on-demand treatment and control of bleeding episodes and perioperative management, calculate dose using the following formulas:
Estimated Increment of Factor VIII (IU/dL or % of normal) = [Total Dose (IU)/body weight (kg)] x 2 (IU/dL per IU/kg)
Required Dose (IU) = Body Weight (kg) x Desired Factor VIII Rise (IU/dL or % of normal) x 0.5 (IU/kg per IU/dL)
• For routine prophylaxis: 50 IU/kg every 4 days. Adjust dose based on patient response with dosing in the range of 25-65 IU/kg at 3-5 day intervals.
• For routine prophylaxis in children less than 6 years of age: 50 IU/kg twice weekly. Adjust dose based on patient response with dosing in the range of 25-65 IU/kg at 3-5 day intervals. More frequent or higher doses up to 80 IU/kg may be required. (2.1)
Pediatric: Clearance (based on per kg body weight) is higher (75%) in pediatric patients 1 to 5 years of age. Higher or more frequent dosing may be needed. (8.4)
|Product NDC||64406-801; 64406-802; 64406-803; 64406-804; 64406-805; 64406-806; 64406-807; 64406-808; 64406-809; 64406-810|
|Date First Approved||14-07-2014|
|Marketing authorisation holder||Biogen Inc.|