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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:
Ensuring prescribers are educated on:
The risk of valvular heart disease and pulmonary arterial hypertension associated with FINTEPLA.
The need to counsel patients on how to recognize and respond to signs and symptoms of valvular heart disease and pulmonary arterial hypertension.
The need to enroll patients in the FINTEPLA REMS.
The need to submit documentation of baseline and periodic cardiac monitoring of patients to identify valvular heart disease and pulmonary arterial hypertension.
Ensuring prescribers adhere to the following:
Enroll patients in the FINTEPLA REMS.
Submit documentation of baseline cardiac monitoring.
Submit documentation of periodic cardiac monitoring.
Ensuring patients are educated on the following:
How to recognize and respond to signs and symptoms of valvular heart disease and pulmonary arterial hypertension.
The need to have baseline and periodic cardiac monitoring.
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.
Enroll in the REMS by completing the Prescriber Enrollment
Form and submitting it to the REMS.
| Prescriber Enrollment Form |
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 Guide |
Provide the patient with the Patient Guide.
| Patient 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 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 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 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 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.
| Cardiovascular Adverse Event Reporting Form |
Report treatment discontinuation or transfer of care to the
REMS.
Enroll in the REMS by completing the Patient Enrollment Form
with the prescriber. Enrollment information will be provided to
the REMS.
| 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 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 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 on behalf of the pharmacy.
Have the authorized representative enroll in the REMS by
completing the Outpatient Pharmacy Enrollment Form and
submitting it to the REMS.
| Outpatient Pharmacy Enrollment Form |
Train all relevant staff involved in dispensing FINTEPLA on the
REMS requirements using the Pharmacy Guide.
| Pharmacy Guide |
Before dispensing
Obtain authorization to dispense by contacting the REMS 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 by
completing the Outpatient Pharmacy Enrollment Form if the
authorized representative changes.
| Outpatient Pharmacy Enrollment Form |
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 UCB, Inc. or a third party
acting on behalf of UCB, 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 enroll in the REMS by
completing the Inpatient Pharmacy Enrollment Form and
submitting it to the REMS.
| Inpatient Pharmacy Enrollment Form |
Train all relevant staff involved in dispensing FINTEPLA on the
REMS requirements using the Pharmacy Guide.
| Pharmacy Guide |
Before dispensing
For patients initiating treatment: Obtain authorization to
dispense each prescription by contacting the REMS 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 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 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.
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 UCB, Inc. or a third party
acting on behalf of UCB, Inc. to ensure that all processes and
procedures are in place and are being followed.
Wholesalers-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 UCB, Inc. or a third party
acting on behalf of UCB, 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).
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.
