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Synribo Generic Name & Formulations
Legal Class
Rx
General Description
Omacetaxine mepesuccinate 3.5mg/vial; lyophilized pwd for SC inj after reconstitution; contains mannitol; preservative-free.
Pharmacological Class
Protein synthesis inhibitor.
How Supplied
Single-use vial—1
Manufacturer
Generic Availability
NO
Synribo Indications
Indications
Treatment of patients with chronic or accelerated phase chronic myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKI).
Synribo Dosage and Administration
Adult
Induction: 1.25mg/m2 by SC inj twice daily (approx. 12hrs apart) for 14 consecutive days every 28 days, over a 28-day cycle. Repeat cycles every 28 days until hematologic response achieved. Maintenance: 1.25mg/m2 by SC inj twice daily for 7 consecutive days every 28 days, over a 28-day cycle, as long as clinically beneficial. Dose adjustments and modifications: see full labeling.
Children
Not established.
Synribo Contraindications
Not Applicable
Synribo Boxed Warnings
Not Applicable
Synribo Warnings/Precautions
Warnings/Precautions
Risk of myelosuppression (thrombocytopenia, neutropenia, anemia) or hemorrhage (cerebral, GI). Monitor CBCs with platelets weekly during induction and initial maintenance cycles, then every 2wks during later cycles. Diabetes: monitor glucose levels frequently; if poorly controlled, avoid until glycemic control is established. Elderly. Embryo-fetal toxicity. Pregnancy (Cat. D); avoid. Nursing mothers: not recommended.
Synribo Pharmacokinetics
See Literature
Synribo Interactions
Interactions
Avoid concomitant anticoagulants, aspirin, NSAIDs if platelets <50,000/microliters.
Synribo Adverse Reactions
Adverse Reactions
Thrombocytopenia, anemia, neutropenia, diarrhea, nausea, fatigue, asthenia, injection site reaction, pyrexia, infection, lymphopenia; bleeding, hyperglycemia.
Synribo Clinical Trials
See Literature
Synribo Note
Not Applicable
Synribo Patient Counseling
See Literature
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