What is the Tegsedi REMS Program?
Medically reviewed by Drugs.com. Last updated on Nov 5, 2020.
Tegsedi REMS is a restricted program where doctors prescribing Tegsedi and pharmacies dispensing Tegsedi must be certified due to its potential dangerous side effects.
Tegsedi (inotersen) from Ionis Pharmaceuticals was approved in October 2018 for the treatment of adults with polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis, a rare and fatal disease leading to amyloid deposits in multiple organs and symptoms throughout the body.
Labeling for Tegsedi contains a Boxed Warning for thrombocytopenia (low platelet counts that may lead to serious bleeding) and glomerulonephritis (acute inflammation of the kidney) and states the once-weekly, subcutaneous injection is only available through a Risk Evaluation and Mitigation Strategy (REMS) restricted program due to these side effects.
What is a REMS?
- A REMS is a strategy to manage side effect associated with certain high risk drugs, and is required by the U.S. Food and Drug Administration (FDA) to ensure the benefits of the drug outweigh its dangers. There are usually several required steps for any REMS.
- Prescribers: To be able to prescribe Tegsedi, prescribers must be certified in the Tegsedi REMS Program, which involves education about the drug and enrollment.
- Prior to prescribing Tegsedi, your doctor will assess your platelet count and kidney function with lab tests.
- Pharmacies: Must also be REMS certified to dispense Tegsedi, which involves pharmacist education, training of staff, and enrollment.
- Patients: A patient (or legal guardian) guide is also available and your prescriber will direct you on enrolling in the Tegsedi REMS. You will learn how to recognize the side effects described in the REMS.