TEGSEDI REMS (Risk Evaluation and Mitigation Strategy) Program

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).

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Pharmacies

Pharmacies must be certified in TEGSEDI REMS to dispense TEGSEDI for adult patients with polyneuropathy of Hereditary Transthyretin-mediated Amyloidosis (hATTR).

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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.

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TEGSEDI is not available to all pharmacies. If you have questions about TEGSEDI REMS or need help with certification or enrollment, call 1-844-483-4736.
Monday-Friday, 8:00am – 8:00pm ET