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Medication Guide    Prescribing Information

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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.
  • Enroll all patients in the REMS.
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PRESCRIBERS

How to prescribe
FINTEPLA


LEARN MORE

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PHARMACIES

How to dispense
FINTEPLA


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PATIENTS

How to receive
FINTEPLA


LEARN MORE

FINTEPLA is indicated for the treatment of seizures associated with Dravet syndrome in patients 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:
Zogenix Inc. at 1-866-964-3649 or
FDA at 1-800-FDA-1088
(www.FDA.gov/medwatch)

For FINTEPLA REMS Information, contact:
Phone: 877-964-3649
Fax: 833-568-6198