FDA approves shared system REMS for TIRF products
Pharmacies and prescribers will be able to enroll in a single shared Risk Evaluation and Mitigation Strategy (REMS) for the transmucosal immediate-release fentanyl (TIRF) products beginning in March.
This new shared system, approved by FDA this week, will replace the individual REMS.
Abstral (ProStrakan), Actiq (Cephalon), Fentora (Cephalon), Lazanda (Archimedes Pharma), and Onsolis (Meda Pharmaceuticals) are among the most common brand-name TIRF medications. These opioids used to manage breakthrough pain in adults with cancer who routinely take other opioid pain mediciations around-the-clock.
Until the shared system strategy, called the TIRF REMS Access Program, is activated, prescribers, patients, and pharmacies should continue to enroll in the individual REMS programs, FDA said in a prepared statement.
“This TIRF REMS will ensure safe use and access to these drugs for patients who need them,” said Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research. “We have worked with the sponsors of both the innovator and generic drugs to develop this single, shared system that will streamline the process and decrease the burden of the REMS on the healthcare system.”
FDA said the system will:
Pharmacies and prescribers already enrolled in an individual REMS program for at least 1 TIRF medications will be transitioned automatically to the shared system, according to FDA.
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