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Approved Risk Evaluation and Mitigation Strategies (REMS)

REMS that have more than one drug product but are not Shared System REMS will not display the product name and ingredient properly on this website due to database limitations. Please refer to the REMS document for the correct product names.

Tegsedi (Inotersen)
NDA #211172
REMS last update: 08/24/2023



What is the purpose of the REMS?

The goal of the TEGSEDI REMS is to mitigate the risk of serious bleeding with severe thrombocytopenia and the risk of glomerulonephritis associated with TEGSEDI by:

  1. Ensuring prescribers are educated on the risk of serious bleeding with severe thrombocytopenia and the risk of glomerulonephritis associated with TEGSEDI.

  2. Ensuring prescribers are educated and adhere to the following:
    • Counsel patients on how to recognize and respond to signs and symptoms of serious bleeding and glomerulonephritis.
    • Enroll patients in the TEGSEDI REMS.
    • Submit documentation that periodic monitoring of patients is being done to identify severe thrombocytopenia, serious bleeding with severe thrombocytopenia, and glomerulonephritis.

  3. Ensuring patients are informed on the following:
    • How to recognize and respond to signs and symptoms of serious bleeding and glomerulonephritis.
    • The need to have their platelet count and renal function monitored.

  4. Enrollment of all patients in a registry to further support long-term safety and safe use of TEGSEDI.

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
08/24/2023 Revised to update REMS Coordinating Center address
03/08/2023

Modified to:

  • Add the Healthcare Provider Reminder Letter for Patient Status Form Submission as a new REMS material and changes to the REMS Document to reflect the requirement to disseminate this letter.
  • Update the existing Prescriber Training to add the Patient Status Form Timing Requirements Reminder Sheet chart as an appendix.
    • 09/14/2022 Revised to make an editorial change
    03/31/2022 Modified to reflect (a) revisions to the REMS Forms to align with the change in the US distributor for Tegsedi from Akcea Therapeutics to Sobi Inc., and (b) addition of a question to the Prescriber Knowledge Assessment to test prescriber knowledge that Tegsedi should generally not be initiated in patients who develop a urinary protein to creatinine ratio (UPCR) of 1000 mg/g or higher.
    05/11/2020

    Modified to make:

  • Changes to the Prescriber Enrollment Form that include the addition of name and contact information fields related to prescriber delegates.
  • Updates to the Patient Status Form including a section that indicates the form may be submitted by a prescriber delegate and the ability of the prescriber to choose from a range of platelet counts to further clarify the level of thrombocytopenia that led to discontinuation.
  • Updates to the Prescriber Knowledge Assessment to revise the answer to one of the questions.

    Revised to make editorial changes.
    • 10/05/2018 Approval of REMS. Revised to reflect change in ownership.

    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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