AMPYRA® (dalfampridine) Extended Release Tablets has a Risk Evaluation and Mitigation Strategy, or REMS, program. What this means is that the Food and Drug Administration (FDA) and Acorda Therapeutics agreed that certain important information about AMPYRA® needs to be communicated to healthcare providers and patients.
The goals of AMPYRA’s REMS program are:
- Inform healthcare providers about the risk of drug-associated seizures in patients treated with AMPYRA.
- Inform healthcare providers about the change of the name from fampridine to dalfampridine upon approval of the drug.
- Inform patients about the serious risks associated with use of AMPYRA.
AMPYRA’s REMS program consists of a Medication Guide for patients and communications plan for healthcare professionals.
A patient Medication Guide is a resource to inform patients of the risks associated with taking a drug, possible side effects of the drug and the best way to safely take their medication. Click here to view the Patient Medication Guide for AMPYRA.
The communications plan for AMPYRA consisted of Acorda Therapeutics sending letters to potential prescribers of AMPYRA and to pharmacists who would be dispensing AMPYRA to make sure that they were informed of the drug-associated risks as well as the change in the name. Click here to view the REMS information.
