Definition of rems program

In practice, a REMS program is a safety strategy that manages a known or potential serious risk associated with a medicine and enables patients to have access to such medicines by managing their safe use.

Related content. REMS patient companion app enables faster, easier surveys. REMS Reports. Addyi flibanserin , tablet NDA Adempas riociguat , tablet, film coated NDA Aveed testosterone undecanoate , injection NDA Blenrep belantamab mafodotin , injection BLA Blincyto blinatumomab , kit BLA Breyanzi lisocabtagene maraleucel , suspension, for intravenous infusion BLA Caprelsa vandetanib , tablet NDA Copiktra duvelisib , capsule NDA Dsuvia sufentanil , tablet, sublingual NDA Empaveli Pegcetacoplan , injection NDA Farydak panobinostat , capsule NDA This is why all prescription drugs include information reviewed and approved by the FDA about how the medication works in the body, its uses and when it should not be used, possible side effects, the recommended dosage, and other facts about the appropriate use of the drug.

REMS programs exist because certain medicines can cause serious side effects, life-threatening infections, allergic reactions, liver damage or birth defects. Before patients take one of these drugs, they and their prescriber should be aware of the risks, and may need to take certain steps that lessen these risks. Without a REMS, these medications would not be approved or would be withdrawn from the market because of known or potential serious risks associated with medication.

The FDA may also seek information from outside experts who provide advice to the agency through advisory committees, as well as patients and caregivers who are living with the problem the drug is designed to treat. REMS may include interventions that support the safe use of the medication. One example might involve a drug that can cause a severe allergic reaction immediately after administration. A REMS is required to ensure the drug is administered only in a health care facility with personnel trained to manage severe allergic reactions and immediate access to necessary treatments and equipment to managing such events.