AFSTYLA®

• 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.

 Do not use in patients who have had life-threatening hypersensitivity reactions, including anaphylaxis to AFSTYLA or its excipients, or hamster proteins.

On-demand treatment and control of bleeding episodes and perioperative management: 

• Dose and duration of treatment depend on the severity of the Factor VIII deficiency, the location and extent of bleeding, and the patient’s clinical condition.
• Each vial of AFSTYLA states the actual amount of Factor VIII activity in International Units (IU) as determined by chromogenic assay. One IU corresponds to the activity of Factor VIII contained in 1 milliliter (mL) of normal human plasma.
• 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  

Routine prophylaxis 

• 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 higher clearance in this age group.

• Administer by intravenous injection. The rate of administration should be determined by the patient’s comfort level. Do not exceed infusion rate of 10 mL per minute.
• Use aseptic technique when administering AFSTYLA.