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Rebinyn Generic Name & Formulations
Legal Class
Rx
General Description
Coagulation Factor IX (recombinant), GlycoPEGylated 500 IU, 1000 IU, 2000 IU; per vial; lyophilized pwd for IV infusion after reconstitution; preservative-free.
Pharmacological Class
Clotting factor.
How Supplied
Single-dose vial—1 (w. diluent, vial adapter)
Manufacturer
Generic Availability
NO
Rebinyn Indications
Indications
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.
Rebinyn Contraindications
Contraindications
Hamster protein hypersensitivity.
Rebinyn Boxed Warnings
Not Applicable
Rebinyn Warnings/Precautions
Warnings/Precautions
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 Pharmacokinetics
See Literature
Rebinyn Interactions
Not Applicable
Rebinyn Adverse Reactions
Adverse Reactions
Itching, inj site reactions; hypersensitivity reactions.
Rebinyn Clinical Trials
See Literature
Rebinyn Note
Not Applicable
Rebinyn Patient Counseling
See Literature
