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FDA Approves Omacetaxine Mepesuccinate for Injection for Home Administration

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The U.S. Food and Drug Administration (FDA) has approved omacetaxine mepesuccinate (Synribo) for injection, for subcutaneous use, to include home administration, and also approved a related Medication Guide and Instructions for Use. With this approval, physicians who treat adults with chronic- or accelerated-phase chronic myeloid leukemia (CML) who are no longer responding to, or who could not tolerate, two or more tyrosine kinase inhibitors will have the option to allow their patients to administer omacetaxine mepesuccinate therapy at home.

Teva Pharmaceutical is working to finalize a comprehensive specialty pharmacy support program which will help facilitate successful home administration of omacetaxine mepesuccinate for health-care professionals, their patients, and caregivers.

“Home administration can reduce the number of required doctor office visits for patients being treated with [omacetaxine mepesuccinate] while still maintaining close collaboration with their health-care provider to manage their treatment regimen,” said Bill Campbell, Vice President and General Manager, Teva Oncology.

“It had been necessary for adults living with chronic or accelerated phase CML who are prescribed [omacetaxine mepesuccinate] to travel to their doctor’s office twice a day for 2 weeks, which can be extremely burdensome and inconvenient to both patients and their caregivers,” said Meir Wetzler, MD, FACP, Chief of the Leukemia Section at Roswell Park Cancer Institute. “Now, physicians can decide if their patients are candidates for self administration, and if so, provide their patients with guidance on how to properly administer reconstituted [omacetaxine mepesuccinate] in the home.”

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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