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Approved Risk Evaluation and Mitigation Strategies (REMS)

Filspari (sparsentan)
NDA #216403
REMS last update: 12/20/2023



What is the purpose of the REMS?

The goal of the FILSPARI REMS is to mitigate the risks of hepatotoxicity and embryo-fetal toxicity associated with FILSPARI:

  1. Objective 1: Monitor for elevations in liver enzymes in patients exposed to FILSPARI
  2. Objective 2: Ensure that patients who can become pregnant are not pregnant before initiating FILSPARI
  3. Objective 3: Minimize exposure in patients who may become pregnant while taking FILSPARI

What do participants need to know?

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
12/20/2023 Revised to make formatting changes.
10/18/2023 Modified to update to the Patient Enrollment Form to include language making patients aware that they may be contacted by Travere or its representatives about voluntary participation in a required post-marketing study on the risk of hepatotoxicity in patient’s taking Filspari.
02/17/2023 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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