What is the TEGSEDI REMS?
A REMS (Risk Evaluation and Mitigation Strategy) is a strategy to manage known or potential risks associated with a drug, and is required by the Food and Drug Administration (FDA) to ensure the benefits of the drug outweigh its risks.
Because of the risk of serious bleeding due to severe thrombocytopenia and the risk of glomerulonephritis, TEGSEDI is available only under a restricted program called the TEGSEDI REMS.
Prescribers
Prescribers must be certified in TEGSEDI REMS to prescribe TEGSEDI for adult patients with polyneuropathy of Hereditary Transthyretin-mediated Amyloidosis (hATTR).
Learn about Prescriber Certification
Pharmacies
Pharmacies must be certified in TEGSEDI REMS to dispense TEGSEDI for adult patients with polyneuropathy of Hereditary Transthyretin-mediated Amyloidosis (hATTR).
Learn about Pharmacy Certification
Patients
Patients who are prescribed TEGSEDI for the treatment of polyneuropathy of Hereditary Transthyretin-mediated Amyloidosis (hATTR) must be enrolled in the TEGSEDI REMS Program.
Learn about Patient Enrollment
Monday-Friday, 8:00am – 8:00pm ET