Fentanyl Buccal Tablets (marketed as Fentora) Information
Fentora (fentanyl buccal tablets) is a an opioid pain medication used for the treatment of breakthrough pain in cancer patients receiving opioid treatment and who have become tolerant to it.
Breakthrough pain is intense increases in pain that occur with rapid onset, even when opioid pain-control medication is being used. Patients who take narcotic pain medications daily and around-the-clock develop tolerance and are more resistant to the dangerous side effects of these medications than patients who take narcotic pain medication on a less frequent basis.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax, using the contact information at the bottom of this page.
- FDA approves shared system REMS for TIRF products
FDA news release (12/29/2011)
Questions and Answers: FDA approves a class Risk Evaluation and Mitigation Strategy (REMS) for transmucosal immediate-release fentanyl (TIRF) medicines
Transmucosal Immediate-Release Fentanyl (TIRF) Medicines FDA Warns of Potential Serious Side Effects with Breakthrough Cancer Pain Drug[ARCHIVED]
Public Health Advisory: Important Information for the Safe Use of Fentora (fentanyl buccal tablets)[ARCHIVED]
Information for Healthcare Professionals: Fentanyl Buccal Tablets (marketed as Fentora)[ARCHIVED]
- Dear Doctor Letter - Fentora (fentanyl buccal) (PDF - 1.1MB)
- Dear Healthcare Professional Letter - Fentora (fentanyl buccal) (PDF - 1.1MB)