Basic Information
AFSTYLA POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 1000IU/VIAL
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Regulatory Information
SIN15823P
September 27, 2019
Prescription Only
Therapeutic
INTRAVENOUS
August 10, 2023
June 4, 2025
XB02BD02
Company Information
Active Ingredients
Strength: 1000IU/vial
Detailed Information
Contraindications
**4.3 Contraindications** AFSTYLA is contraindicated in patients who have had life-threatening hypersensitivity reactions, including anaphylaxis to AFSTYLA or any of its components, or hamster proteins.
Indication Information
**4.1 Therapeutic indications** AFSTYLA is indicated in adults and pediatrics with hemophilia A (congenital factor VIII deficiency) for: - Control and prevention of bleeding episodes, - Routine prophylaxis to prevent or reduce the frequency of bleeding episodes. - Perioperative prophylaxis (surgical prophylaxis) AFSTYLA is not indicated for treatment of Von Willebrand disease.