Adynovate Is Here!
Leigh Carpenter, RPh
Director of Pharmacy
On November 13, 2015, the FDA approved Adynovate, manufactured by Baxalta, for hemophilia A. Adynovate is a new recombinant long-acting factor VIII approved for both on-demand treatment and for routine prophylaxis in adults and adolescents aged 12 years or older. The product should last longer in the blood than regular factor VIII products because it contains full-length factor VIII molecules linked to other PEGylated molecules (polyethylene glycol). Adynovate is the only product with an extended half-life built on the same factor VIII protein as Advate. It is the first product to be launched by Baxalta, formerly Baxter BioScience.
The dose for routine prophylaxis is 40-50 units per kg body weight twice weekly, which allows patients to infuse on the same two days every week. On-demand dosing depends on the type of bleeding and the patient’s clinical response. Data from a study of 137 patients showed that Adynovate was effective in reducing and controlling bleeding episodes, compared with Advate.
Initially, Adynovate will be available in four dosage strengths: 250IU, 500IU, 1,000IU and 2,000IU. Each size will be reconstituted with 5ml sterile water for injection. The product may be stored at refrigerated temperature (36- 46 degrees Fahrenheit) until the expiration date on the vial label and box or at room temperature (not to exceed 86 degrees Fahrenheit) for up to one month. If the product is stored at room temperature, write the date on the carton when it was removed from refrigeration and do NOT return Adynovate to the refrigerator. Each package also contains a BAXJECT II Hi-Flow needleless transfer device for easy mixing.
If you have questions about Adynovate, please contact your Hemophilia Treatment Center physician.