Fenfluramine

Valvular Heart Disease and Pulmonary Arterial Hypertension

• There is an association between serotonergic drugs with 5-HT2B receptor agonist activity, including fenfluramine (the active ingredient in FINTEPLA), and valvular heart disease and pulmonary arterial hypertension. 
• Echocardiogram assessments are required before, during, and after treatment with FINTEPLA. 
• FINTEPLA is available only through a restricted program called the FINTEPLA REMS

Approved Risk Evaluation and Mitigation Strategies (REMS)

FINTEPLA (fenfluramine) Oral Solution)

Patient Counseling Information

• FINTEPLA

Medication Guides

Patient Medication Guide - GINTEPLA

Package Inserts

Fenfluramine