Synribo

Adults with chronic or accelerated phase CML with resistance and/or intolerance to two or more TKIs.

Induction: 1.25 mg/m2 SC BID for 14 consecutive days every 28 days. Maintenance: 1.25 mg/m2 SC BID for 7 days every 28 days.

Injection: 3.5 mg lyophilized powder in single-dose vial

None listed in the prescribing information.

• Myelosuppression: Monitor CBCs weekly during induction, every 2 weeks during maintenance.
• Hemorrhage: Fatal cerebral hemorrhage and GI hemorrhage reported.
• Hyperglycemia: Monitor blood glucose.
• Embryo-Fetal Toxicity: Can cause fetal harm.

Thrombocytopenia (67%), Anemia (55%), Neutropenia (47%), Diarrhea (42%), Nausea (32%), Fatigue (31%), Pyrexia (29%), Injection Site Reaction (25%), Arthralgia (19%)

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

No formal drug interaction studies conducted.

Consult the full prescribing information for pregnancy-related considerations.

Refer to prescribing information for lactation guidance.

Pediatric safety and efficacy information is detailed in the full label.

Dose modifications for organ impairment are specified in the complete prescribing information.

Omacetaxine mepesuccinate is a cephalotaxine ester that inhibits protein synthesis by binding to the A-site cleft of the ribosomal peptidyl-transferase center, preventing initial elongation step of protein synthesis. This mechanism is independent of BCR-ABL binding, providing activity against TKI-resistant CML including T315I mutations.

Tmax: ~0.5 hours SC. Protein binding: <50%. Half-life: ~6 hours. Elimination: primarily feces.

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

• CML-202 — Omacetaxine in TKI-resistant CML. Phase II, n=122.
  🔬 NCT00375219 ↗

Synribo has FDA-approved indications across the following cancer types covered on CancerDrugEvidence: