Generic Name and Formulations:
Omacetaxine mepesuccinate 3.5mg/vial; lyophilized pwd for SC inj after reconstitution; contains mannitol; preservative-free.
Indications for SYNRIBO:
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).
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.
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.
Avoid concomitant anticoagulants, aspirin, NSAIDs if platelets <50,000/microliters.
Protein synthesis inhibitor.
Thrombocytopenia, anemia, neutropenia, diarrhea, nausea, fatigue, asthenia, injection site reaction, pyrexia, infection, lymphopenia; bleeding, hyperglycemia.