Subcutaneous twice-daily administration
SYNRIBO® is dosed based on body surface area (1.25 mg/m2)
SYNRIBO is administered subcutaneously twice daily at approximately 12-hour intervals
While SYNRIBO should be prepared in a healthcare facility and must be reconstituted by a healthcare professional (HCP), there are two options for administration: home administration or administration by an HCP
If a patient (or their caregiver) is an appropriate candidate for home administration, SYNRIBO can be prepared by a specialty pharmacy and shipped along with all necessary supplies directly to the patient. The patient or caregiver must be trained on proper handling, storage conditions, administration, disposal, and clean-up of accidental spillage of SYNRIBO before they are allowed to administer at home
If a patient is not an appropriate candidate or cannot be trained for any reason, SYNRIBO should be administered by an HCP
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: 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.
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