IndicationSYNRIBO ® (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 ®
- 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
- You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
About SYNRIBO ®SYNRIBO ® is the first protein synthesis inhibitor and was originally granted an accelerated approval by the FDA in October 2012. In February of 2014 the FDA granted SYNRIBO a full approval based on the submission of 24 month update to the safety and efficacy data. While a detailed understanding of how SYNRIBO works has not been fully defined, it has been shown in laboratory studies not including patients, to prevent the production of specific proteins. The proteins affected by SYNRIBO are known as Bcr-Abl and Mcl-1. These are examples of some of the proteins that are produced in higher levels by cancerous CML cells and help drive the disease. As a protein synthesis inhibitor, the way SYNRIBO ® is believed to work does not directly depend on Bcr-Abl binding. For Full Prescribing Information, click here: http://www.synribo.com/pdf/synribo_pi.pdf About Teva Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is the world's leading generic drug maker, with a global product portfolio of more than 1,000 molecules and a direct presence in approximately 60 countries. Teva's Specialty Medicines businesses focus on CNS, respiratory oncology, pain, and women's health therapeutic areas as well as biologics. Teva currently employs approximately 45,000 people around the world and reached $20.3 billion in net revenues in 2013. 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