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.

ADVERSE REACTIONS | WARNINGS AND PRECAUTIONS

Warnings and Precautions
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EFFECTIVENESS IN CHRONIC PHASE CML

See the response rates achieved in chronic phase patients   

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EFFECTIVENESS IN ACCELERATED PHASE CML

See the response rates achieved in accelerated phase patients   

Warnings and Precautions

Some adverse reactions, such as myelosuppression and cerebral hemorrhage, have been fatal. Patients receiving SYNRIBO®® should be monitored closely for these reactions

In clinical trials, myelosuppression was usually managed by delaying the next cycle and/or reducing days of treatment

  • Myelosuppression was generally reversible

Treatment considerations for specific populations

Pregnancy: There are no adequate and well-controlled trials in pregnant women. SYNRIBO can cause fetal harm when administered to pregnant women

Nursing mothers: Because many drugs are excreted in human milk and because of the potential for serious adverse reaction in nursing infants from omacetaxine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother

Pediatric use: Safety and effectiveness of SYNRIBO in pediatric patients have not been established

Renal or hepatic impairment: No formal trials assessing the impact of renal or hepatic impairment on the pharmacokinetics of omacetaxine mepesuccinate have been conducted

Geriatric use: In measuring primary endpoints, there were higher rates of response in younger patients (<65 years) compared with older patients (≥65 years). With regard to safety, patients ≥65 years were more likely to experience toxicity, most notably hematologic toxicity

Effect of gender: In measuring MCyR rate in chronic phase patients (n=76) by gender, there were higher rates of response in men (21%) than women (14%). Though there were differences noted in the safety profile of SYNRIBO in male and female chronic phase patients, the small number of patients prevents a definitive assessment. There were inadequate patient numbers in the accelerated phase subset to draw conclusions regarding a gender effect on efficacy

Indication

  • 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 USMedInfo@tevapharm.com