A new medicine for treating hemophilia B, Rebinyn Coagulation Factor X (recombinant), GlycoPEGlated, has been made available to pharmacies.
Officials with Novo Nordisk announced that a new medicine for treating hemophilia B, Rebinyn Coagulation Factor X (recombinant), GlycoPEGlated, has been made available to pharmacies. The drug was FDA-approved in May 2017 for treating and controlling bleeding in adults and children.
Rebinyn is an extended half-life injectable medicine. According to Novo Nordisk, it replaces the clotting Factor IX that is missing in people with hemophilia B, and can be used to treat bleeds when they occur, as well as help manage bleeding during surgery. Rebinyn is not for routine prophylaxis (regular infusions to prevent bleeding) or for immune tolerance induction (treatment of inhibitors) in patients with hemophilia B, the manufacturer said.
In phase 3 studies, a single dose of Rebinyn 40 IU/kg in adults was shown to elevate factor activity above baseline levels by 94 percent and sustain average factor levels of 17 percent seven days post-dose. Adults also achieved an 83-hour average half-life after receiving a single infusion of Rebinyn, according to Novo Nordisk.
In a press release, Guy Young, M.D., Director of the Hemostasis and Thrombosis Program at Children's Hospital Los Angeles, and an investigator in the paradigm clinical trial program studying Rebinyn, said an extended half-life treatment that can quickly control a bleed with one or two doses is an important part of hemophilia B care for patients. "Even with significant progress in the treatment of hemophilia B, there is an ongoing need for medicines that help patients reach and maintain high Factor IX levels for a longer period of time," he said.
Rebinyn is administered as an infusion into the vein. It should only be used by patients who have been taught to give themselves an infusion by a health care provider or hemophilia treatment center. Patients should not use Rebinyn is they are allergic to Factor IX, hamster proteins or any other ingredients in the drug.
According to Novo Nordisk, common adverse effects of Rebinyn include swelling, pain, rash or redness at the infusion location, and itching. Signs of an allergic reaction to Rebinyn may include hives, chest tightness, wheezing, difficulty breathing, and swelling of the face.
For more information about Rebinyn, visit www.Rebinyn.com.