Updated product label allows home administration of omacetaxine mepesuccinate.

The U.S. Food and Drug Administration’s accelerated approval of omacetaxine mepesuccinate for the treatment of chronic-phase or accelerated-phase chronic myeloid leukemia has been converted to full approval. Approved changes to the omacetaxine administration guidelines to allow home administration using syringes prepared by a health care professional will improve patient access to treatment by alleviating the need for daily visits to a medical facility during treatment, while also addressing concerns regarding the ability of patients or caregivers to accurately prepare and administer injections safely.