FDA (Food and Drug Administration, USA)
Do not use in patients who have had life-threatening hypersensitivity reactions, including anaphylaxis to AFSTYLA or its excipients, or hamster proteins. (4)
• Hypersensitivity reactions, including anaphylaxis, are possible. Should symptoms occur, immediately discontinue AFSTYLA and administer appropriate treatment. (5.1)
• Development of Factor VIII neutralizing antibodies (inhibitors) can 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)
• If the one-stage clotting assay is used, multiply the result by a conversion factor of 2 to determine the patient’s Factor VIII activity level. (5.3)
• Each vial of AFSTYLA 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)
• Plasma Factor VIII levels can be monitored using either a chromogenic assay or a one-stage clotting assay – routinely used in US clinical laboratories. If the one-stage clotting assay is used, multiply the result by a conversion factor of 2 to determine the patient’s Factor VIII activity level. (2.1, 5.3)
Calculating Required Dose: (2.1)
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: (2.1)
• Adults and adolescents (≥12 years): The recommended starting regimen is 20 to 50 IU per kg of AFSTYLA administered 2 to 3 times weekly.
• Children (<12 years): The recommended starting regimen is 30 to 50 IU per kg of AFSTYLA administered 2 to 3 times weekly. More frequent or higher doses may be required in children <12 years of age to account for the higher clearance in this age group.
• The regimen may be adjusted based on patient response.
Perioperative Management: (2.1)
• Ensure the appropriate Factor VIII activity level is achieved and maintained.
|Product NDC||69911-474; 69911-475; 69911-476; 69911-477; 69911-478|
|Date First Approved||25-05-2016|
|Marketing authorisation holder||CSL Behring, LLC|