AFSTYLA Now Available
by Leigh Carpenter, RPh, Director of Pharmacy
In May, the FDA approved AFSTYLA, a recombinant factor VIII manufactured by CSL Behring for the treatment of hemophilia A. AFSTYLA was specifically designed for a longer duration of action. It is indicated for adults and pediatric patients for on-demand treatment and routine prophylaxis, as well as perioperative management of bleeding. In clinical trials, patients on prophylaxis with AFSTYLA experienced an average bleed rate of zero. There were no inhibitors observed in these clinical trials.
The recommended starting dose for routine prophylaxis administered two or three times a week is 20-50 units/kg for patients 12 years and older and 30-50 units/kg for patients less than 12 years of age. In the clinical trials, those infusing the product twice a week used an average of 35 units/kg for people of all ages. In those infusing three times a week, the average dose was 30 units/kg for people 12 and older and 32 units/kg for those less than 12 years of age. The flexible dosing is adjusted based on patient response. Higher or more frequent dosing may be needed for patients under 12 years of age.
AFSTYLA comes from the Chinese hamster ovary (CHO) cell line and the approval was based on results from the AFFINITY clinical study. It is marketed as the first and only recombinant factor VIII single-chain therapy for hemophilia A. The single-chain factor VIII is specifically designed for greater molecular stability and longer duration of action. It uses a covalent bond that forms one structural entity. It is not indicated for the treatment of von Willebrand Disease.
AFSTYLA is available in five dosage strengths: 250 IU, 500 IU, 1000 IU, 2000 IU and 3000 IU. Each size is color coded on the packaging. The diluent volume is 2.5mls for the 250, 500 and 1000 IU sizes and 5mls for the 2000 and 3000 IU sizes. AFSTYLA uses the Mix2Vial needle-less mixing device. The product can be stored at room temperature for up to three months (not to exceed 77 degrees F). Once stored at room temperature, do not return the product to the refrigerator. You can also store in the refrigerator (36 to 46 degrees F) up to the expiration date.
If you are interested in trying AFSTYLA, please contact your Hemophilia Treatment Center physician.