Get Btod Rems

Risk Evaluation and Mitigation Strategies (REMS)

These medications are , esketamine (Spravato) and for extended-release injectable suspension (® Relprevv™).

Which pain medicines are included in this REMS? Oral dosage forms containing: codeine and codeine analogs, , , , meperidine, , , , , , . Intranasal .

The drug products subject to the -containing Transmucosal products for Opioid Dependence (BTOD) REMS include: ® () sublingual tablets and generic equivalents. ® ( and naloxone) sublingual tablets and sublingual films and generic equivalents.

Types of REMS Requirements. REMS include a risk mitigation goal, and are comprised of information communicated to and/or required activities to be undertaken by one or more participants (e.g., health care providers, pharmacists, patients) who prescribe, dispense or take the medication.

FDA determines if a REMS is necessary. The agency may seek information from outside experts or other participants (e.g., patients and health care providers), or may seek advice through an FDA advisory committee in making this determination.

Which pain medicines are included in this REMS? The branded and generic drug products subject to this REMS include all the following: Oral dosage forms containing: codeine and codeine analogs, , , , meperidine, , , , , , .

They are required when certain specific risks exist that might otherwise limit the approvability and use of medications. At this time, there are 76 REMS approved by the FDA, and a link below can be used to access a full list of REMS.