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Synribo 3.5mg Vial
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Indications & Clinical Uses
- Synribo (omacetaxine mepesuccinate) 3.5mg is a protein-synthesis inhibitor supplied as a single-use vial, approved in the US for adults with chronic myeloid leukaemia (CML) in the chronic or accelerated phase whose disease is resistant to, or who cannot tolerate, two or more prior tyrosine kinase inhibitor medicines (such as imatinib, dasatinib or nilotinib).
- It is not a first-line treatment and is not approved for blast-phase CML.
- Synribo is given by subcutaneous injection; it may be given by a nurse initially, but patients or caregivers can self-inject at home once properly trained, typically twice daily for 14 days of a 28-day induction cycle, reduced to 7 days for maintenance.
Side Effects
- The most common effects are low blood counts (low platelets, low white cells, low red cells), infections, diarrhoea, nausea, tiredness, weakness, injection-site reactions such as redness, swelling or pain, fever and raised blood sugar.
- Low platelets can cause serious bleeding, including in the stomach or brain - seek urgent help for unusual bruising, blood in urine or stool, or a severe headache.
- Low white cells raise infection risk, so report fever or chills promptly.
- There is no formal boxed warning on the current label, but regular blood-count monitoring is required.
- Rotate injection sites between doses.
Precautions & Warnings
- Blood counts must be checked before treatment starts, weekly during induction, and before each later cycle; treatment is delayed or the dose adjusted for severe myelosuppression.
- Blood sugar should be monitored closely, especially in people with or at risk of diabetes, and treatment may be deferred until glucose is controlled.
- Synribo can harm an unborn baby, so effective contraception is required during treatment for anyone who could become pregnant; breastfeeding should be avoided during treatment and for at least 2 weeks after the last dose.
- It may also reduce male fertility.
- Use caution in significant liver or kidney impairment, where data are limited.
Avoid Interactions
- No formal drug-drug interaction studies are described on the current label.
- Because Synribo lowers blood counts, avoid live vaccines during treatment and use caution with other medicines that also suppress bone marrow, which can add to infection or bleeding risk.
- Tell your healthcare provider about all other medicines, including any tyrosine kinase inhibitors or other CML treatments, and about diabetes medicines, given the risk of raised blood sugar.
- Report new fever, bleeding or bruising promptly while on treatment.
References
Frequently Asked Questions
Synribo (omacetaxine mepesuccinate) treats chronic myeloid leukaemia (CML) in adults whose disease is resistant to, or who cannot tolerate, two or more prior tyrosine kinase inhibitor medicines. It blocks protein production inside leukaemia cells and is used for chronic or accelerated-phase CML, not as a first treatment.
Synribo is given as a subcutaneous injection under the skin, usually into the thigh, abdomen or back of the arm, twice daily for 14 days of a 28-day cycle at first, then 7 days for later cycles. A nurse can teach you or a caregiver to give it at home.
The most common effects are low blood counts, infections, diarrhoea, nausea, tiredness and injection-site redness or pain. Low platelets can cause serious bleeding, including in the brain or stomach - get urgent help for unusual bruising, blood in urine or stool, or a severe headache.
Avoid live vaccines and tell your healthcare provider about every medicine you take, since Synribo lowers blood counts and raises infection and bleeding risk. If you have diabetes, monitor blood sugar closely, as Synribo can worsen high blood sugar. Effective contraception is needed during treatment.
Your care team checks your blood counts before treatment starts, weekly during the first cycles, and before every later cycle, since Synribo can cause severe low blood counts. Doses may be delayed or adjusted based on these results, so keep every scheduled blood test appointment.
Synribo can harm an unborn baby, so effective contraception is required during treatment for anyone who could become pregnant. Do not breastfeed during treatment or for at least 2 weeks after the last dose. Synribo may also reduce male fertility; discuss family planning with your doctor first.
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