Rebinyn Approved for Hemophilia B
May 31, 2017 – The U.S. FDA has approved Rebinyn® [Coagulation Factor IX (Recombinant), GlycoPEGylated)], manufactured by Novo Nordisk. Rebinyn is indicated to control bleeding episodes—including before and after surgery—for patients with Hemophilia B. Hemophilia B is a hereditary bleeding disorder that affects approximately 4,000 patients in the United States. Patients with the disorder produce insufficient amounts of clotting Factor IX, which leads to bleeding episodes that cause pain, irreversible joint damage and potentially life-threatening hemorrhages.
Also known as nonacog beta pegol or N9-GP, Rebinyn is an extended-release form of blood clotting Factor IX. Dosing for Rebinyn is as needed. The drug is infused intravenously (IV) at 40 international units (IU) per kg of the patient’s body weight for minor-to-moderate bleeds or invasive procedures; and at 80IU/kg for more serious bleeds or major surgery. Rebinyn is not approved for regular use to prevent bleeding episodes. Launch is anticipated in early 2018 through a limited network of specialty pharmacies.
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 U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. 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.