Indicated for the treatment of adult patients with chronic or accelerated phase chronic myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKI). Learn about Important Safety Information including Warnings and Precautions regarding Myelosuppression, Bleeding, Hyperglycemia, and Embryo-Fetal Toxicity.



See the response rates achieved in chronic phase patients   



See the response rates achieved in accelerated phase patients   

Efficacy population was drawn from 2 pivotal clinical trials

Chronic and accelerated phase adult patients (N=111) evaluated for efficacy were derived from a combined cohort of 2 clinical trials: CML-202 (patients with CML who failed prior imatinib therapy) and CML-203 (patients with CML who failed TKI therapy)1

Patients studied had resistance or intolerance to 2 or more TKIs in addition to prior CML treatments

*TKI therapy includes imatinib, nilotinib, and/or dasatinib.

Primary endpoints

  • Chronic phase: MCyR (CCyR or PCyR, up to 35% Ph+ cells)
  • Accelerated phase: MaHR (CHR or NEL) and/or MCyR
Abbreviations: MCyR is major cytogenetic response, CCyR is complete cytogenetic response, PCyR is partial cytogenetic response, Ph+ is Philadelphia chromosome positive, MaHR is major hematologic response, CHR is complete hematologic response, NEL is no evidence of leukemia.


  • SYNRIBO®® (omacetaxine mepesuccinate) for injection, for subcutaneous use, is indicated for the treatment of adult patients with chronic or accelerated phase chronic myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKI)

Important Safety Information

Warnings and Precautions

  • Myelosuppression: Patients with chronic phase and accelerated phase CML who used SYNRIBO experienced severe and fatal myelosuppression including thrombocytopenia, neutropenia, and anemia. Patients with neutropenia are at increased risk for infections, and should be monitored frequently and advised to contact a physician if they have symptoms of infection or fever. Monitor complete blood counts weekly during induction and initial maintenance cycles and every two weeks during later maintenance cycles, as clinically indicated
  • Bleeding: SYNRIBO causes severe thrombocytopenia which increases the risk of hemorrhage. Fatalities from cerebral hemorrhage have occurred. Severe, non-fatal gastrointestinal hemorrhages have also occurred. Monitor platelet counts as part of the complete blood count (CBC) monitoring as recommended. Avoid anticoagulants, aspirin, and non-steroidal anti-inflammatory drugs (NSAIDs) when the platelet count is <50,000/µL as they may increase the risk of bleeding
  • Hyperglycemia: SYNRIBO can induce glucose intolerance. Monitor blood glucose levels frequently, especially in patients with diabetes or risk factors for diabetes. Avoid SYNRIBO in patients with poorly controlled diabetes mellitus until good glycemic control has been established
  • Embryo-Fetal Toxicity: SYNRIBO can cause fetal harm when administered to a pregnant woman. Women should be advised to avoid becoming pregnant while using SYNRIBO

Adverse Reactions

  • Serious adverse reactions (frequency ≥5%) in chronic phase patients: bone marrow failure, thrombocytopenia, febrile neutropenia, and infections
  • Serious adverse reactions (frequency ≥5%) in accelerated phase patients: febrile neutropenia, thrombocytopenia, anemia, diarrhea, and infections
  • Most common adverse reactions (frequency ≥20%) in chronic and accelerated phase patients: thrombocytopenia, anemia, neutropenia, diarrhea, nausea, fatigue, asthenia, injection site reaction, pyrexia, infection, and lymphopenia
TO REPORT SIDE EFFECTS: Contact us at 1-800-896-5855 or
  1. Data on File. Frazer, PA: Teva Pharmaceuticals, Inc.