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)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:
- Ensuring prescribers are educated on the risk of serious bleeding with severe thrombocytopenia and the risk of glomerulonephritis associated with TEGSEDI.
- 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.
- 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.
- 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
Healthcare providers who prescribe TEGSEDI must:
To become certified to prescribe |
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Before treatment initiation (first dose) |
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During treatment; weekly or more frequently as described in the Prescribing Information |
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During treatment; every two weeks |
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During treatment; every 90 days |
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After treatment discontinuation; weekly for 8 weeks or more frequently as described in the Prescribing Information |
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After treatment discontinuation; every 2 weeks for 8 weeks |
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After treatment discontinuation; at 8 weeks |
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At all times |
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Patients who are prescribed TEGSEDI:
Before treatment initiation (first dose) |
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During treatment; every week or more often as directed by the prescriber |
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During treatment; every two weeks |
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After treatment discontinuation; weekly for 8 weeks or more often as directed by the prescriber |
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After treatment discontinuation; every 2 weeks for 8 weeks |
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At all times |
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Pharmacies that dispense TEGSEDI must:
To become certified to dispense |
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Before dispensing |
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To maintain certification to dispense |
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At all times |
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Wholesalers-distributors that distribute TEGSEDI must:
To be able to distribute |
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At all times |
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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 Tegsedi REMS, see the DailyMed link(s).Material Name | Material Name Link |
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Healthcare Provider Reminder Letter for Patient Status Form Submission (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2023_08_24_Healthcare_Provider_Reminder_Letter_for_Patient_Status_Form_Submission.pdf |
Patient Enrollment Form (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2023_08_24_Patient_Enrollment_Form.pdf |
Patient Guide (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2023_08_24_Patient_Guide.pdf |
Patient Status Form (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2023_08_24_Patient_Status_Form.pdf |
Patient Wallet Card (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2023_08_24_Patient_Wallet_Card.pdf |
Pharmacy Enrollment Form (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2023_08_24_Pharmacy_Enrollment_Form.pdf |
Prescriber Enrollment Form (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2023_08_24_Prescriber_Enrollment_Form.pdf |
Prescriber Knowledge Assessment (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2023_08_24_Prescriber_Knowledge_Assessment.pdf |
Prescriber Training (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2023_08_24_Prescriber_Training.pdf |
Program Overview (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2023_08_24_Program_Overview.pdf |
REMS Document (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2023_08_24_REMS_Document.pdf |
REMS Full (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2023_08_24_REMS_Full.pdf |
REMS Website (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2023_08_24_REMS_Website.pdf |
What assessment is available to the REMS?
Assessment Plan |
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REMS assessment plan unavailable for posting at this time. |
What updates have been made to the REMS?
Date | Summary of change |
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08/24/2023 | Revised to update REMS Coordinating Center address |
03/08/2023 | Modified to: |
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: |
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.