- 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: Based on findings from animal reproduction studies and the drug’s mechanism of action, SYNRIBO can cause fetal harm when administered to a pregnant woman. Conduct pregnancy testing prior to initiating treatment and advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use an effective method of contraception during treatment with SYNRIBO and for 6 months after the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with SYNRIBO and for 3 months after the final dose. SYNRIBO may impair male fertility.
- Lactation: Advise patients that breastfeeding is not recommended during treatment with SYNRIBO, and for at least 2 week after the final dose.
- 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
- Adams KW, Cooper GM. Rapid turnover of Mcl-1 couples translation to cell survival and apoptosis. J Biol Chem. 2007;282:6192-6200.
- 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.
- 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.