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.

UNIQUE ACTION | MOA VIDEO

THE FIRST PROTEIN SYNTHESIS INHIBITOR
FOR CML
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STUDIED IN HEAVILY PRETREATED PATIENTS

See how SYNRIBO was evaluated   

SYNRIBO® acts independently of direct BCR-ABL1 binding

The mechanism of action has not been fully elucidated

Reduces protein levels of both BCR-ABL1 and Mcl-1, an inhibitor of apoptosis, as demonstrated in vitro

SYNRIBO Acts independently of Bcr-Abl

Shows activity in wild-type and T315I mutated CML, as demonstrated in murine models

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 1-888-483-8279 or USMedInfo@tevapharm.com
References
  1. Adams KW, Cooper GM. Rapid turnover of Mcl-1 couples translation to cell survival and apoptosis. J Biol Chem. 2007;282:6192-6200.
  2. Daley GQ, Van Etten RA, Baltimore D. Induction of chronic myelogenous leukemia in mice by the P210bcr/abl gene of the Philadelphia chromosome. Science. 1990;247:824-830.
  3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Chronic Myeloid Leukemia V.4.2018 – January 28, 2018. ©National Comprehensive Cancer Network, Inc. 2018. All rights reserved. Accessed April 17, 2018. To view the most recent and complete version of the guideline, go online to NCCN.org. The National Comprehensive Cancer Network makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.