FDA.reportPublic FDA data

FILSPARI - Travere Therapeutics, Inc.

Manufacturer
Travere Therapeutics, Inc.
Effective date
2026-04-13
Label type
RISK EVALUATION & MITIGATION STRATEGIES
Version
13
Source
full-release
Hydrated at
2026-06-04 22:50:45

Label at a glance#

ProductFILSPARI
Label structure6 sections

Label contents#

Full prescribing information#

I. ADMINISTRATIVE INFORMATION

REMS Administrative Information

Risk: hepatotoxicity

Application Number: NDA 216403

Application Holder: Travere Therapeutics, Inc.

Initial REMS Approval: 02/2023

Most Recent REMS Update: 04/2026

II. REMS GOAL

REMS Goals

The goal of the FILSPARI REMS is to mitigate the risk of hepatotoxicity associated with FILSPARI:

  • Objective 1: Monitor for elevations in liver enzymes in patients exposed to FILSPARI

III. REMS Requirements

REMS Requirements

Travere Therapeutics, Inc. must ensure that healthcare providers, patients, pharmacies, and wholesalers-distributors comply with the following requirements:

REMS Participant Requirements

1. Healthcare Providers who prescribe FILSPARI must:

To become certified to prescribe

  1. Review the drug’s Prescribing Information.
  2. Review the following: Prescriber and Pharmacy Guide.
  3. Enroll in the REMS by completing the Prescriber Enrollment Form and submitting it to the REMS.

Before treatment initiation (first dose)

  1. Counsel the patient on the risk of hepatotoxicity associated with FILSPARI, the signs and symptoms of liver problems, to contact the prescriber if the patient has any signs or symptoms of liver problems, on the REMS requirements including the need to complete liver testing every 3 months during treatment, and that FILSPARI is only available through a restricted distribution program using the Patient Guide.
  2. Assess the patient’s liver function. Document and submit to the REMS using the Patient Enrollment Form.
  3. Provide the patient with the Patient Guide.
  4. Enroll the patient by completing the Patient Enrollment Form and submitting it to the REMS.

During treatment, every 3 months

  1. Assess the patient’s liver function.
  2. Counsel the patient on the risk of hepatotoxicity if they are not complying with the required liver testing.

At all times

  1. Report adverse events suggestive of hepatotoxicity to the REMS.

REMS Participant Requirements

2. Patients who are prescribed FILSPARI:

Before treatment initiation (first dose)

  1. Review the Patient Guide.
  2. Get a liver test.
  3. Receive counseling from the prescriber on the risk of liver problems, the signs and symptoms of liver problems, the need to contact the prescriber if you have any signs or symptoms of liver problems, and the need to complete liver testing every 3 months during treatment using the Patient Guide.
  4. Enroll in the REMS by completing the Patient Enrollment Form with the prescriber. Enrollment information will be provided to the REMS.
  5. Receive counseling from the pharmacy on the risk of liver problems associated with FILSPARI treatment.

During treatment, every 3 months

  1. Get a liver test.
  2. Adhere to the safe use condition: Communicate with the pharmacy to confirm completion of liver testing.
  3. Receive counseling from the pharmacy on the risk of liver problems associated with FILSPARI treatment.

At all times

  1. Inform the prescriber if you have any signs or symptoms of liver problems as described in the Patient Guide.

REMS Participant Requirements

3. Outpatient pharmacies that dispense FILSPARI must:

To become certified to dispense

  1. Designate an authorized representative to carry out the certification process and oversee implementation and compliance with the REMS on behalf of the pharmacy.
  2. Have the authorized representative review the Prescriber and Pharmacy Guide.
  3. Have the authorized representative certify by enrolling in the REMS by completing the Outpatient Pharmacy Enrollment Form and submitting it to the REMS.
  4. Train all relevant staff involved in dispensing on the REMS requirements using the Prescriber and Pharmacy Guide.
  5. Establish processes and procedures to verify the patient is enrolled and the prescriber is certified.
  6. Establish processes and procedures to document and submit confirmation of counseling on the risk of hepatotoxicity.
  7. Establish processes and procedures to verify and document the patient’s liver testing is complete or the prescriber authorizes the refill.

Before dispensing

  1. Verify the patient is enrolled and the prescriber is certified through the processes and procedures established as a requirement of the REMS.

Before dispensing; at initial dispense, then every 3 months

  1. Counsel the patient on the risk of hepatotoxicity. Document and submit confirmation of counseling through the processes and procedures established as a requirement of the REMS.
  2. Verify and document the patient’s liver testing is complete or the prescriber authorizes the refill through the processes and procedures established as a requirement of the REMS.

At all times

  1. Dispense no more than a 90-days’ supply.
  2. Report adverse events suggestive of hepatotoxicity to the REMS.
  3. Not distribute, transfer, loan, or sell FILSPARI, except to certified dispensers.
  4. Maintain and submit records of product dispensing to the REMS.
  5. Maintain records that all processes and procedures are in place and are being followed.
  6. Comply with audits carried out by Travere Therapeutics, Inc. or a third party acting on behalf of Travere Therapeutics, Inc. to ensure that all processes and procedures are in place and are being followed.

To maintain certification to dispense

  1. Have a new authorized representative enroll by completing and submitting an Outpatient Pharmacy Enrollment Form, if the authorized representative changes.

REMS Participant Requirements

4. Inpatient pharmacies that dispense FILSPARI must:

Become certified to dispense

  1. Designate an authorized representative to carry out the certification process and oversee implementation and compliance with the REMS on behalf of the pharmacy.
  2. Have the authorized representative review the Prescriber and Pharmacy Guide.
  3. Have the authorized representative certify by enrolling in the REMS by completing the Inpatient Pharmacy Enrollment Form and submitting it to the REMS.
  4. Train all relevant staff involved in dispensing on the REMS requirements using the Prescriber and Pharmacy Guide.
  5. Establish processes and procedures to verify and document the patient is enrolled or will be enrolled prior to discharge, the patient is under the care of a certified prescriber, and liver testing is complete.

Before dispensing

  1. Counsel the patient on the risk of hepatotoxicity. Document and submit confirmation of counseling through the processes and procedures established as a requirement of the REMS.
  2. Verify and document the patient is enrolled or will be enrolled prior to discharge, the patient is under the care of a certified prescriber, and liver testing is complete.

At discharge

  1. Dispense no more than a 30-days’ supply.

At all times

  1. Report adverse events suggestive of hepatotoxicity to the REMS.
  2. Not distribute, transfer, loan, or sell FILSPARI, except to certified dispensers.
  3. Maintain records that all processes and procedures are in place and are being followed.
  4. Comply with audits carried out by Travere Therapeutics, Inc. or a third party acting on behalf of Travere Therapeutics, Inc. to ensure that all processes and procedures are in place and are being followed.

To maintain certification to dispense

  1. Have a new authorized representative enroll by completing and submitting an Inpatient Pharmacy Enrollment Form, if the authorized representative changes.

REMS Participant Requirements

5. Wholesalers-distributors that distribute FILSPARI must:

To be able to distribute

  1. Establish processes and procedures to ensure that FILSPARI is distributed only to certified pharmacies.
  2. Train all relevant staff involved in distribution on the REMS requirements.

At all times

  1. Distribute only to certified pharmacies.
  2. Maintain and submit records of drug distribution to the REMS.
  3. Maintain records that all processes and procedures are in place and are being followed.
  4. Comply with audits carried out by Travere Therapeutics, Inc., or a third party acting on behalf of Travere Therapeutics, Inc. to ensure that all processes and procedures are in place and are being followed.

REMS Applicant Requirements

Travere Therapeutics, Inc. must provide training to healthcare providers who prescribe FILSPARI.

The training includes the following educational material: Prescriber and Pharmacy Guide. The training must be available online and hard copy format via fax or mail.

Travere Therapeutics, Inc. must provide training to pharmacies that dispense FILSPARI.

The training includes the following educational material: Prescriber and Pharmacy Guide. The training must be available online and hard copy format via fax or mail.

To support REMS operations, Travere Therapeutics, Inc. must:

  1. Authorize outpatient dispensing based on verifying the patient is enrolled and the prescriber is certified.
  2. Establish and maintain a REMS Website, www.FILSPARIREMS.com. The REMS Website must include the capability to complete prescriber and inpatient pharmacy certification online, the capability to enroll and manage patients online, and the option to print the Prescribing Information, Medication Guide, and REMS materials. All product websites for consumers and healthcare providers must include prominent REMS-specific links to the REMS Website. The REMS Website must not link back to the promotional product website(s).
  3. Make the REMS Website fully operational and all REMS materials available through the website and REMS Coordinating Center at the time FILSPARI first becomes commercially available.
  4. Establish and maintain a REMS Coordinating Center for REMS participants at 1-833-513-1325.
  5. Establish and maintain a validated, secure database of all REMS participants who are enrolled and certified in the REMS.
  6. Ensure prescribers and inpatient pharmacies are able to complete the certification process by fax and online.
  7. Ensure outpatient pharmacies are able to complete the certification process by fax.
  8. Ensure prescribers are able to complete the patient enrollment process by fax and online.
  9. Ensure pharmacies are able to verify the patient is enrolled and the prescriber is certified by phone and online.
  10. Ensure pharmacies are able to enroll as inpatient (including, but not limited to, pharmacies in hospitals, long-term care facilities, prisons, and state psychiatric units) or outpatient pharmacies.
  11. Notify prescribers and pharmacies of their REMS certification within one business day.
  12. Provide the Prescriber Enrollment Form and the Prescriber and Pharmacy Guide to prescribers who (1) attempt to prescribe FILSPARI and are not yet certified or (2) inquire about how to become certified.
  13. Provide certified prescribers access to the database of certified pharmacies and enrolled patients.
  14. Provide certified pharmacies access to the database of certified prescribers and enrolled patients.

To ensure REMS participants’ compliance with the REMS, Travere Therapeutics, Inc. must:

  1. Verify the name and contact information of the pharmacy’s authorized representative every 2 years. If different than the current authorized representative on file, the pharmacy is required to recertify with a new authorized representative.
  2. Maintain adequate records to demonstrate that REMS requirements have been met, including, but not limited to records of: FILSPARI distribution and dispensing; certification of prescribers and pharmacies; enrolled patients; and audits of REMS participants. These records must be readily available for FDA inspections.
  3. Establish and maintain a plan for addressing non-compliance with REMS requirements.
  4. Monitor prescribers, pharmacies, and wholesaler-distributors on an ongoing basis to ensure the requirements of the REMS are being met. Take corrective action if non-compliance is identified, including de-certification.
  5. Audit all certified outpatient pharmacies and wholesaler-distributors within 180 calendar days after they become certified to ensure that all REMS processes and procedures are in place, functioning, and support the REMS requirements.
  6. Audit annually: 1) all certified outpatient pharmacies, 2) a representative sample of inpatient pharmacies that have ordered FILSPARI in the past year, 3) all wholesaler-distributors, and 4) the REMS Coordinating Center to ensure that all the REMS processes and procedures are in place, functioning, and support the REMS requirements.
  7. Take reasonable steps to improve operations of and compliance with the requirements in the REMS based on monitoring and evaluation of the REMS.

IV. REMS ASSESSMENT TIMETABLE

REMS Timetable for Submission Assessments

Travere Therapeutics, Inc. must submit REMS Assessments at 12 months, and annually from the date of the initial REMS approval (02/17/2023). To facilitate inclusion of as much information as possible while allowing reasonable time to prepare the submission, the reporting interval covered by each assessment should conclude no earlier than 60 calendar days before the submission date for that assessment. Travere Therapeutics, Inc. must submit each assessment so that it will be received by the FDA on or before the due date.

V. REMS Materials

REMS Material

The following materials are part of the FILSPARI REMS:

Enrollment Forms

Prescriber:

  1. Prescriber Enrollment Form

Patient:

  1. Patient Enrollment Form

Pharmacy:

  1. Outpatient Pharmacy Enrollment Form
  2. Inpatient Pharmacy Enrollment Form

Training and Educational Materials

Prescriber:

  1. Prescriber and Pharmacy Guide

Patient:

  1. Patient Guide

Pharmacy:

  1. Prescriber and Pharmacy Guide

Other Materials

  1. REMS Website

VI. STATUTORY ELEMENTS

REMS Elements

This REMS is required under section 505-1 of the Federal Food, Drug and Cosmetic Act (FD&C Act) and consists of the following elements:

  1. Elements to Assure Safe Use
    1. Health care providers who prescribe FILSPARI are specially certified under 505-1(f)(3)(A).
    2. Pharmacies that dispense FILSPARI are specially certified under 505-1(f)(3)(B).
    3. FILSPARI is dispensed to patients with evidence or other documentation of safe-use conditions under 505-1(f)(3)(D).
    4. Each patient using FILSPARI is subject to certain monitoring under 505-1(f)(3)(E).
  2. Implementation System
  3. Timetable for Submission of Assessments

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1947407-f4b4-4068-9aaf-a0fe7a1945c6Product name120240223

DailyMed REMS / Drug Safety Documents#

Labels related to this REMS document

DailyMed label, Relation, Version table
DailyMed labelRelationVersionEffectiveManufacturerSource
These highlights do not include all the information needed to use FILSPARI ® safely and effectively. See full prescribing information for FILSPARI ® . FILSPARI ® (sparsentan) tablets, for oral use Initial U.S. Approval: 2023SPL related document2026-04-09Travere Therapeutics, Inc. | Catalent CTS, LLC | AndersonBrecon Inc.20260430_4f44558f-50bb-4670-a4d0-d58c64aa09bb.zip!1efc782c-198f-410d-a3e5-4857ce863c69.xml

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FILSPARISPARSENTANTravere Therapeutics, Inc.d7354af1-f304-f4d9-e053-2995a90ab2192026-04-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: FILSPARI

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