These highlights do not include all the information needed to use AFSTYLA safely and effectively. See full prescribing information for AFSTYLA.
AFSTYLA®, Antihemophilic Factor (Recombinant), Single Chain Lyophilized Powder for Solution for Intravenous Injection
Initial U.S. Approval: 2016
INDICATIONS AND USAGE
AFSTYLA, Antihemophilic Factor (Recombinant), Single Chain, is a recombinant, antihemophilic factor indicated in adults and children with hemophilia A (congenital Factor VIII deficiency) for:
On-demand treatment and control of bleeding episodes,
Routine prophylaxis to reduce the frequency of bleeding episodes,
Perioperative management of bleeding.
Limitation of Use
AFSTYLA is not indicated for the treatment of von Willebrand disease (1).
DOSAGE AND ADMINISTRATION
For intravenous use after reconstitution only.
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) �- Desired Factor VIII Rise (IU/dL or % of normal) �- 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.
DOSAGE FORMS AND STRENGTHS
AFSTYLA is available as a white or slightly yellow lyophilized powder supplied in single-dose vials containing nominally 250, 500, 1000, 1500, 2000, 2500, or 3000 International Units (IU). (3)
CONTRAINDICATIONS
Do not use in patients who have had life-threatening hypersensitivity reactions, including anaphylaxis to AFSTYLA or its excipients, or hamster proteins. (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity reactions, including anaphylaxis, are possible. Should symptoms occur, immediately discontinue AFSTYLA and administer appropriate treatment. (5.1)
Formation of neutralizing antibodies (inhibitors) to Factor VIII has been reported following administration of AFSTYLA; previously untreated patients (PUPs) are at greater risk.. 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)
ADVERSE REACTIONS
The most common adverse reactions reported in clinical trials (>0.5% of subjects) were dizziness and hypersensitivity. (6)
To report SUSPECTED ADVERSE REACTIONS, contact the CSL Behring Pharmacovigilance Department at 1-866-915-6958 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Pediatric: Clearance (based on per kg body weight) is higher in pediatric patients 0 to <12 years of age. Higher and/or more frequent dosing may be needed. (8.4)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 4/2021
