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In male and female rats, tirzepatide caused dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether tirzepatide-induced thyroid C-cell tumors in rodents have any relevance to humans, and therefore it is unknown whether tirzepatide causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans.
Tirzepatide is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Patients should be informed of the potential risk of MTC with the use of tirzepatide and advised of symptoms of thyroid tumors (e.g., neck mass, dysphagia, dyspnea, persistent hoarseness). The clinical value of routine monitoring of serum calcitonin or thyroid ultrasound for early detection of MTC in patients treated with tirzepatide is uncertain.
Tirzepatide is contraindicated in patients with:
1. A personal or family history of medullary thyroid carcinoma (MTC);
2. Multiple Endocrine Neoplasia syndrome type 2 (MEN 2);
3. Known serious hypersensitivity to tirzepatide or to any of the excipients in tirzepatide.
4. Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with the use of tirzepatide.
