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Approved Risk Evaluation and Mitigation Strategies (REMS)

Fintepla (fenfluramine hydrochloride)
NDA #212102
REMS last update: 03/25/2022



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 See Disclaimer page regarding links to external sites

Healthcare providers who prescribe FINTEPLA must:

To become certified to prescribe (first dose)
Before treatment initiation (first dose)
  • Counsel the patient on the risks of valvular heart disease and pulmonary arterial hypertension, including how to recognize and respond to signs and symptoms of valvular heart disease and pulmonary arterial hypertension, and the need for cardiac monitoring via echocardiogram at baseline (treatment initiation), every 6 months during treatment, and once 3 to 6 months after treatment discontinuation using the Patient Guide.
    | Patient Caregiver Guide |
  • Provide the patient with the Patient Guide.
    | Patient Caregiver Guide |
  • Enroll the patient by completing and submitting the Patient Enrollment Form to the REMS.
    | Patient Enrollment Form |
  • Assess the patient’s cardiovascular status and the appropriateness of initiating treatment by obtaining an echocardiogram. Document and submit the results and authorization for treatment to the REMS Program using the Patient Status Form.
    | Patient Status Form |
During treatment: Every 6 months
  • Counsel the patient on the need for cardiac monitoring via echocardiogram every 6 months during treatment using the Patient Guide.
    | Patient Caregiver Guide |
  • Assess the patient’s cardiovascular status and the appropriateness of continuing treatment by obtaining an echocardiogram. Document and submit the results and appropriateness of continued treatment to the REMS Program using the Patient Status Form.
    | Patient Status Form |
After treatment discontinuation: 3 to 6 months
  • Assess the patient’s cardiovascular status by obtaining an echocardiogram. Document and submit the results to the REMS Program using the Patient Status Form.
    | Patient Status Form |
At all times
  • Report adverse events suggestive of valvular heart disease and/or pulmonary arterial hypertension on the Cardiovascular Adverse Event Reporting Form to the REMS Program.
    | Cardiovascular Adverse Event Reporting Form |
  • Report treatment discontinuation or transfer of care to the REMS Program.

Patients who are prescribed FINTEPLA:

Before treatment initiation
  • Review the Patient Guide.
    | Patient Caregiver Guide |
  • Enroll in the REMS by completing the Patient Enrollment Form with the prescriber. Enrollment information will be provided to the REMS Program.
    | Patient Enrollment Form |
  • Receive counseling from the prescriber on the risk of valvular heart disease and pulmonary arterial hypertension, including how to recognize signs and symptoms of valvular heart disease and pulmonary arterial hypertension, and the need to get an echocardiogram before treatment, every 6 months during treatment, and once 3 to 6 months after treatment discontinuation using the Patient Guide.
    | Patient Caregiver Guide |
  • Get an echocardiogram to check your heart.
During treatment: Every 6 months
  • Receive counseling from the prescriber on the need to get an echocardiogram every 6 months during treatment using the Patient Guide.
    | Patient Caregiver Guide |
  • Get an echocardiogram to check your heart.
After treatment discontinuation: 3 to 6 months
  • Get an echocardiogram to check your heart.
At all times
  • Inform the prescriber if any signs or symptoms of valvular heart disease or pulmonary arterial hypertension develop.
  • Inform all healthcare providers about this treatment.

Outpatient pharmacies that dispense FINTEPLA must:

To become certified to dispense
  • Designate an authorized representative to carry out the certification process and oversee implementation and compliance with the REMS Program on behalf of the pharmacy.
  • Have the authorized representative review the Pharmacy Guide and REMS Program Overview.
  • Have the authorized representative enroll in the REMS Program by completing the Outpatient Pharmacy Enrollment Form and submitting it to the REMS.
  • Train all relevant staff involved in dispensing FINTEPLA on the REMS requirements using the Pharmacy Guide.
Before dispensing
  • Obtain authorization to dispense by contacting the REMS Program to verify that the prescriber is certified, and the patient is enrolled and authorized to receive the drug.
To maintain certification to dispense
  • Have the new authorized representative enroll in the REMS Program by completing the Outpatient Pharmacy Enrollment Form if the authorized representative changes.
At all times
  • Not distribute, transfer, loan, or sell FINTEPLA, except to certified pharmacies.
  • Maintain records of dispensing information.
  • Maintain records that all processes and procedures are in place and being followed.
  • Maintain records documenting staff’s completion of REMS training.
  • Comply with audits carried out by Zogenix, Inc. or a third party acting on behalf of Zogenix, Inc. to ensure that all processes and procedures are in place and are being followed.

Inpatient pharmacies that dispense FINTEPLA must:

To become certified to dispense
  • Designate an authorized representative to carry out the certification process and oversee implementation and compliance with the REMS on behalf of the pharmacy.
  • Have the authorized representative review the Pharmacy Guide and REMS Program Overview.
  • Have the authorized representative enroll in the REMS by completing the Inpatient Pharmacy Enrollment Form and submitting it to the REMS.
  • Train all relevant staff involved in dispensing FINTEPLA on the REMS Program requirements using the Pharmacy Guide.
Before dispensing
  • For patients initiating treatment: Obtain authorization to dispense each prescription by contacting the REMS Program to verify that the prescriber is certified, and the patient is enrolled and authorized to receive the drug.
  • For patients continuing treatment: Obtain authorization to dispense each prescription by contacting the REMS Program to verify that the patient is enrolled and authorized to receive the drug.
At discharge
  • Dispense no more than 15 days’ supply.
To maintain certification to dispense
  • Have the new authorized representative enroll in the REMS Program by completing the Inpatient Pharmacy Enrollment Form if the authorized representative changes.
    | Inpatient Pharmacy Enrollment Form |
At all times
  • Not distribute, transfer, loan, or sell FINTEPLA. 10. Maintain records of dispensing information.
  • Maintain records that all processes and procedures are in place and being followed.
  • Maintain records that document staff’s completion of REMS training.
  • Comply with audits carried out by Zogenix, Inc. or a third party acting on behalf of Zogenix, Inc. to ensure that all processes and procedures are in place and are being followed.

Wholesale-distributors that distribute FINTEPLA must:

To be able to distribute
  • Establish processes and procedures to ensure that the drug is distributed only to certified pharmacies.
  • Train all relevant staff involved in distributing FINTEPLA on the REMS requirements.
At all times
  • Distribute FINTEPLA only to certified pharmacies.
  • Maintain records of all distributions.
  • Comply with audits carried out by Zogenix, Inc. or a third party acting on behalf of Zogenix, Inc. to ensure that all processes and procedures are in place and are being followed.

What materials are included in the REMS?

The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers. For a specific Medication Guide of a product in the Fintepla REMS, see the DailyMed link(s).
Material Name Material Name Link
Cardiovascular Adverse Event Reporting Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2022_03_25_Cardiovascular_Adverse_Event_Reporting_Form.pdf
Inpatient Pharmacy Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2022_03_25_Inpatient_Pharmacy_Enrollment_Form.pdf
Letter for Healthcare Providers (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2022_03_25_Letter_for_Healthcare_Providers.pdf
Outpatient Pharmacy Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2022_03_25_Outpatient_Pharmacy_Enrollment_Form.pdf
Patient Caregiver Guide (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2022_03_25_Patient_Caregiver_ Guide.pdf
Patient Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2022_03_25_Patient_Enrollment_Form.pdf
Patient Status Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2022_03_25_Patient_Status_ Form.pdf
Pharmacy Guide (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2022_03_25_Pharmacy_Guide .pdf
Prescriber Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2022_03_25_Prescriber_Enrollment_Form.pdf
Prescriber Knowledge Assessment (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2022_03_25_Prescriber_ Knowledge_Assessment.pdf
Prescriber Training (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2022_03_25_Prescriber_Training .pdf
Program Overview (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2022_03_25_Program_Overview.pdf
REMS Document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2022_03_25_REMS_Document.pdf
REMS Full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2022_03_25_REMS_Full.pdf
REMS Program Website Screenshots (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Fintepla_2022_03_25_REMS_Program_Website_Screenshots.pdf

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
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.

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