New Indications for Adynovate

December 27, 2016 – The U.S. Food and Drug Administration (FDA) approved Shire’s Adynovate® (antihemophilic factor [recombinant], PEGylated), a long-acting factor VIII product for two additional indications. Initially approved in November 2015 to treat bleeding episodes and to reduce the frequency of bleeds for patients with hemophilia A who are 12 years of age and older, Adynovate is now also approved for use by patients younger than 12 years. Additionally, it received FDA approval for use to control bleeding for patients with hemophilia A of any age during surgery. Adynovate can be injected as needed to manage bleeding episodes. To prevent bleeds, it is given intravenously (IV) on a twice-weekly schedule with dosing based on the patient’s weight.

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call           1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability. 

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.