What is the FINTEPLA REMS (Risk Evaluation and Mitigation Strategy)?
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 Overview
Only certified healthcare providers can prescribe FINTEPLA.
Only certified pharmacies can dispense FINTEPLA.
Educate patients on the risks of developing problems with the heart valves or high blood pressure in the arteries of the lungs.