Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions
FDA Approves Rebinyn to Treat Hemophilia B
Novo Nordisk news release; 2018 Feb 8
The FDA has approved Rebinyn for the treatment of hemophilia B.
Indications: Rebinyn, Coagulation Factor IX (Recombinant), GlycoPEGylated, is a recombinant DNA-derived coagulation Factor IX concentrate indicated for use in adults and children with hemophilia B for:
- On-demand treatment and control of bleeding episodes.
- Perioperative management of bleeding.
Dosage and administration: 40 IU/kg body weight for minor and moderate bleeds/minor surgery, and 80 IU/kg body weight for major bleeds/major surgery.
Efficacy and safety: In phase 3 studies, a single dose of 40 IU/kg in adults elevated factor activity above baseline levels by 94% and sustained average factor levels of 17% 7 days post-dose. Adults also achieved an 83-hour average half-life after receiving a single infusion.
Side effects/risks: The most common adverse reactions are itching and injection site reactions.
Novo Nordisk launches Rebinyn in the United States for people with hemophilia B. [news release]. Plainsboro, NJ: Novo Nordisk Inc. February 8, 2018. http://press.novonordisk-us.com/2018-02-08-Novo-Nordisk-Launches-Rebinyn-R-in-the-United-States-for-People-with-Hemophilia-B. Accessed February 12, 2018.
Rebinyn [package insert]. Plainsboro, NJ: Novo Nordisk Inc. 2018. https://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM561316.pdf. Accessed February 12, 2018.