Diplomat has announced that it will be distributing SYNRIBO (omacetaxine mepesuccinate), now approved by the US Food and Drug Administration for subcutaneous injection and home administration.
SYNRIBO is a treatment for adults with chronic myeloid leukemia (CML) who are no longer responding to or are unable to tolerate two or more tyrosine kinase inhibitors (TKIs). The new labeling for the product gives prescribers the option to allow patients to administer their SYNRIBO therapy in the comfort and convenience of their own home.
Previously, patients prescribed SYNRIBO were required to travel to their doctor’s office twice a day for a two-week period to receive treatment. The administration schedule placed a burden on patients and their caregivers that created a potential barrier to treatment.
Diplomat has an established injection training program that offers in-home nursing visits to teach patients to self-administer injectable medications. With Diplomat’s program, support for patients continues throughout their treatment to ensure continued success with subcutaneous injections.
SYNRIBO is manufactured by Teva Pharmaceutical Industries and originally received accelerated FDA approval in October 2012, with full approval following in February 2014. SYNRIBO is the first protein synthesis inhibitor for CML that has been shown in laboratory studies to prevent the production of specific proteins Bcr-Abl and Mcl-1, which are produced by cancerous CML cells.