Coagulation Factor IX, recombinant, glycopegylated (Rebinyn)

Coagulation Factor IX, recombinant, glycopegylated (Rebinyn®)

OFFICE-ADMINISTRATION

FDA Approved Indications:

• Indicated for use in adults and children with hemophilia B for:
  • On-demand treatment and control of bleeding episodes
  • Perioperative management of bleeding
• Limitations of use: Rebinyn is NOT indicated for routine prophylaxis in the treatment of patients with hemophilia B.  Rebinyn is NOT indicated for immune tolerance induction in patients with hemophilia B.

Prior authorization criteria:

• Patient has hemophilia B, AND
• Patient does not have a known hypersensitivity to hamster protein

Dosing:

• On-demand treatment and control of bleeding episodes: 40IU/kg body weight for minor and moderate bleeds, and 80 IU/kg body weight for major bleeds.  Additional doses of 40 IU/kg can be given.
• Perioperative management: Pre-operative dose of 40 IU/kg body weight for minor surgery, and 80 IU/kg body weight for major surgery.  As clinically needed for the perioperative management of bleeding, repeated doses of 40 IU/kg (in 1-3 day intervals) within the first week after major surgery may be administered.  Frequency may be extended to once weekly after the first week until bleeding stops and helaing is achieved.