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SYNRIBO
Leukemias, lymphomas, and other hematologic cancers
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Drug Name:

SYNRIBO Rx

Generic Name and Formulations:
Omacetaxine mepesuccinate 3.5mg/vial; lyophilized pwd for SC inj after reconstitution; contains mannitol; preservative-free.

Company:
Teva Pharmaceuticals

Therapeutic Use:

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).

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.

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.

Interactions:

Avoid concomitant anticoagulants, aspirin, NSAIDs if platelets <50,000/microliters.

Pharmacological Class:

Protein synthesis inhibitor.

Adverse Reactions:

Thrombocytopenia, anemia, neutropenia, diarrhea, nausea, fatigue, asthenia, injection site reaction, pyrexia, infection, lymphopenia; bleeding, hyperglycemia.

Generic Availability:

NO

How Supplied:

Single-use vial—1

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