What are the indications and usage?
SYNRIBO for Injection 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). This indication is based upon response rate. There are no trials verifying an improvement in disease-related symptoms or increased survival with SYNRIBO.
How supplied/storage and handling ?
SYNRIBO (omacetaxine mepesuccinate) for Injection is supplied in 8 mL clear glass single- use vial in individual cartons. Each vial contains 3.5 mg of SYNRIBO (omacetaxine mepesuccinate) for Injection (NDC 63 459-177-14).
Store at 20 o C to 25ºC (68 o C to 77ºF); excursions permitted from 15ºC to 30ºC (59ºF to 86ºF). Until use, keep product in carton to protect from light.