Transmucosal Opioid for Patients with Cancer
Fentanyl (Abstral) transmucosal tab lets were approved to manage breakthrough pain for adults with cancer. Abstral is specifically indicated for patients aged ≥18 years who are already using opioid pain medication around the clock and who need and are able to safely use high doses of an additional opioid medicine.
To reduce potential misuse of the pro duct, Abstral will be available only through a Risk Evaluation and Mitigation Strategy (REMS) program. In addition, only professionals trained in the use of Schedule II opioids for pain should prescribe this product.
Transdermally administered medications are placed inside the cheek, gums, tongue, the nasal passages, or throat where they dissolve and are absorbed.
Abstral was evaluated in 311 opioidtolerant cancer patients with breakthrough pain. Common adverse reactions included nausea, constipation, drowsiness, and headache; serious events, including death, have been reported in patients using other immediate-release fentanyl products. (January 7, 2011)