Clinical Edge

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. Accessed February 12, 2018.

Rebinyn [package insert]. Plainsboro, NJ: Novo Nordisk Inc. 2018. Accessed February 12, 2018.

This Week's Must Reads

Higher AML, MDS risk linked to autotransplants, Radivoyevitch T et al. Leuk Res. 2018 Jul 19. pii: S0145-2126(18)30160-7

CMS wants to flatten E/M payments, CMS proposed rule, CMS-1693-P

Lay health workers can assist with end-of-life care, Patel MI et al. JAMA Oncology. 2018 Jul 26. doi: 10.1001/jamaoncol.2018.2446.

New guidelines from the UK on chronic lymphocytic leukemia, Schuh AH et al. Br J Haematol. 2018 Jul 15. doi: 10.1111/bjh.15460

JAK1/2 inhibitors tied to increased B-cell lymphoma risk, Porpaczy E et al. Blood. 2018 Jun 14. doi: 10.1182/blood-2017-10-810739.

Must Reads in Bleeding Disorders

Avatrombopag reduces procedure-related transfusions in chronic liver disease and thrombocytopenia, Terrault N et al. Gastroenterology. 2018 May 17. doi: 10.1053/j.gastro.2018.05.025.

Prehospital plasma improves odds of survival in hemorrhagic shock, Sperry JL et al. N Engl J Med. 2018 Jul 26;379(4):315-26.

Thrombocytopenia in pregnancy raises risk of complications, Reese J et al. N Engl J Med. 2018;379:32-43.

Red cell tranfusion may increase risk of postsurgical VTE, Goel R et al. JAMA Surg. 2018 Jun 13. doi: 10.1001/jamasurg.2018.1565

Dapagliflozin suppresses hepcidin, boosts hematocrit, Ghanim HA et al. AACE 2018, Abstract 228.