Rebinyn Generic Name & Formulations
Coagulation Factor IX (recombinant), GlycoPEGylated 500 IU, 1000 IU, 2000 IU; per vial; lyophilized pwd for IV infusion after reconstitution; preservative-free.
Single-dose vial—1 (w. diluent, vial adapter)
On-demand treatment and control of bleeding in hemophilia B. Peri-operative management of bleeding in hemophilia B. Routine prophylaxis to reduce the frequency of bleeding episodes.
Limitations of Use
Not for immune tolerance induction in patients with hemophilia B.
Rebinyn Dosage and Administration
Adults and Children
Infuse slowly over 1–4mins. On-demand treatment/control of bleeding: Minor/Moderate: 40 IU/kg as single dose. Major: 80 IU/kg as single dose. Both: additional doses of 40 IU/kg can be given. Peri-op management: Minor: 40 IU/kg as single dose; repeat doses if needed. Major: 80 IU/kg as single dose; if needed, repeat doses of 40 IU/kg (in 1–3 day intervals) within first week, then may extend to once weekly until bleeding stops and healing is achieved. Routine prophylaxis: 40 IU/kg once weekly. Administer within 4 hours after reconstitution at room temperature.
Hamster protein hypersensitivity.
Rebinyn Boxed Warnings
Discontinue and treat if hypersensitivity symptoms occur. Monitor for development of Factor IX inhibitors; perform an assay that measures Factor IX inhibitor concentration if bleeding is not controlled with recommended dose or if the expected plasma activity levels are not attained. Potential risk for thromboembolic complications; monitor for signs of thrombotic and consumptive coagulopathy in patients with liver disease, post-operatively, neonates, or at risk for thrombosis or disseminated intravascular coagulation (DIC). Nephrotic syndrome. Avoid use of silica-based reagents to monitor Factor IX activity. Pregnancy. Nursing mothers.
Rebinyn Adverse Reactions
Itching, inj site reactions; hypersensitivity reactions.
Rebinyn Clinical Trials
Rebinyn Patient Counseling