Generic Name and Formulations:
Coagulation Factor IX (recombinant), GlycoPEGylated 500 IU, 1000 IU, 2000 IU; per vial; lyophilized pwd for IV infusion after reconstitution; preservative-free.
Indications for REBINYN:
On-demand treatment and control of bleeding in hemophilia B. Peri-operative management of bleeding in hemophilia B.
Limitations Of use:
Not for routine prophylaxis or immune tolerance induction in patients with hemophilia B.
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. Administer within 4 hours after reconstitution at room temperature.
Hamster protein hypersensitivity.
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.
Itching, inj site reactions; hypersensitivity reactions.
Single-use vial—1 (w. diluent, vial adapter)
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