The FINTEPLA REMS is a safety program to manage the risk of valvular heart disease and pulmonary arterial hypertension. The REMS is required by the U.S. Food and Drug Administration (FDA) to ensure the potential benefits of FINTEPLA outweigh its risks.
FINTEPLA REMS OverviewFINTEPLA is a medicine used to treat seizures in people with Dravet syndrome or Lennox-Gastaut syndrome who are 2 years of age and older.
To learn more about the serious risks associated with FINTEPLA, please refer to the Prescribing Information, Prescriber Training, Pharmacy Guide, and REMS Program Overview
To report adverse reactions or side effects, contact:
UCB Inc. at 1-844-599-2273 or
FDA at 1-800-FDA-1088
(www.FDA.gov/medwatch)
For FINTEPLA REMS information,
contact: Phone: 877-964-3649
Fax: 833-568-6198
