Approved Risk Evaluation and Mitigation Strategies (REMS)

Fintepla (fenfluramine hydrochloride)

NDA #212102

REMS last update: 04/02/2024

• View Fintepla's Regulatory Information at Drugs@FDA

• Goals
• Summary
• REMS Materials
• Assessment Plan
• Update history

What is the purpose of the REMS?

The goal of the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS) Program is to mitigate the risk of valvular heart disease and pulmonary arterial hypertension associated with FINTEPLA, by:

1. Ensuring prescribers are educated on:
1. The risk of valvular heart disease and pulmonary arterial hypertension associated with FINTEPLA.
2. The need to counsel patients on how to recognize and respond to signs and symptoms of valvular heart disease and pulmonary arterial hypertension.
3. The need to enroll patients in the FINTEPLA REMS.
4. The need to submit documentation of baseline and periodic cardiac monitoring of patients to identify valvular heart disease and pulmonary arterial hypertension.
2. Ensuring prescribers adhere to the following:
1. Enroll patients in the FINTEPLA REMS.
2. Submit documentation of baseline cardiac monitoring.
3. Submit documentation of periodic cardiac monitoring.
3. Ensuring patients are educated on the following:
1. How to recognize and respond to signs and symptoms of valvular heart disease and pulmonary arterial hypertension.
2. The need to have baseline and periodic cardiac monitoring.
4. Enrolling of all patients in a registry to further support the long-term safety and safe use of FINTEPLA.

What do participants need to know?

Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the application holder(s) REMS Website or the approved REMS materials for more information.

View application holder(s) REMS Website

What assessment is available to the REMS?

Assessment Plan
REMS assessment plan unavailable for posting at this time.

What updates have been made to the REMS?

Date	Summary of change
04/02/2024	Modified to remove the communication plan and make the following changes: REMS Document—changes to the Timetable for Submission of Assessments Cardiovascular Adverse Event (CVAE) Reporting Form—questions added regarding previous fenfluramine exposure in a clinical trial and treatment start and stop dates, as well as editorial changes. Patient Status Form—questions added regarding pulmonary arterial systolic pressure value, previous submission of CVAE Reporting Form and changes in reported abnormalities, as well as editorial changes. Website Screenshots—changes
05/30/2023	Modified to: change the application holder for NDA 212102 from Zogenix to UCB, Inc. reflect the removal by the Drug Enforcement Administration(DEA) of fenfluramine from the schedules of the Controlled Substances Act (CSA) align the Fintepla REMS Document with the FDA guidance “Format and Content of a REMS Document: Guidance for Industry”
03/25/2022	Modified to make changes to the REMS materials to align with the inclusion of the second indication for the treatment of seizures associated with LGS in patients who are 2 years of age and older and associated labeling changes pertaining to the risk for valvular heart disease and pulmonary arterial hypertension.
06/25/2020	Approval of the REMS.

Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.