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Approved Risk Evaluation and Mitigation Strategies (REMS)

Riociguat Shared System REMS
Shared System REMS
REMS last update: 09/01/2022

What medicines are included in the REMS?

Product Name Application Number Application Holder Added to REMS DailyMed Link FDA Link
Adempas (riociguat) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 204819 BAYER HLTHCARE 10/08/2013 7b57509a-3d5d-41d4-8fed-1471e26372a3 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=204819
riociguat (Info at Drugs@FDA) ANDA 211135 MSN 09/01/2022

What is the purpose of the REMS?

The goal of the Riociguat REMS Program is to mitigate the risk of embryo-fetal toxicity associated with riociguat by:

  1. Ensuring prescribers are educated on the following:
    • the risk of embryo-fetal toxicity
  2. Ensuring prescribers are educated on and adhere to the following:
    • counseling patients about the risk and the need for monthly monitoring
    • enrolling patients in the Riociguat REMS Program
    • monitoring patients at baseline and monthly
  3. Ensuring that pharmacies are educated on the following:
    • the risk of embryo-fetal toxicity
  4. Ensuring that pharmacies are educated on and adhere to the following:
    • confirming that the appropriate patient monitoring and counseling has occurred before dispensing riociguat
  5. Ensuring that patients are informed about:
    • the risk of embryo-fetal toxicity
    • appropriate baseline and monthly patient monitoring
    • appropriate contraception

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

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
09/01/2022 Approval of the Shared System 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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