Approved Risk Evaluation and Mitigation Strategies (REMS)
Tegsedi (Inotersen)
NDA #211172
REMS last update: 05/11/2020
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 Program.
- 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 your 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 your 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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At all times |
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Wholesaler-distributors that distribut 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 |
---|---|
Patient Enrollment Form (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2020_05_11_Patient_Enrollment_Form.pdf |
Patient Guide (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2020_05_11_Patient_Guide.pdf |
Patient Status Form (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2020_05_11_Patient_Status_Form.pdf |
Patient Wallet Card (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2020_05_11_Patient_Wallet_Card.pdf |
Pharmacy Enrollment Form (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2020_05_11_Pharmacy_Enrollment_Form.pdf |
Prescriber Enrollment Form (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2020_05_11_Prescriber_Enrollment_Form.pdf |
Prescriber Knowledge Assessment (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2020_05_11_Prescriber_Knowledge_Assessment.pdf |
Prescriber Training (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2020_05_11_Prescriber_Training.pdf |
REMS Document (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2020_05_11_REMS_Document.pdf |
REMS Full (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2020_05_11_REMS_Full.pdf |
REMS Program Overview (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2020_05_11_REMS_Program_Overview.pdf |
REMS Website Screenshots (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Tegsedi_2020_05_11_REMS_Website_Screenshots.pdf |
What updates have been made to the REMS?
Date | Summary of change |
---|---|
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.
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