From the FDA Drug Label
OZEMPIC is contraindicated in patients with: • A personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Warnings and Precautions (5.1)].
- 1 Risk of Thyroid C-Cell Tumors In mice and rats, semaglutide caused a dose-dependent and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure at clinically relevant plasma exposures [see Nonclinical Toxicology (13. 1)]. It is unknown whether OZEMPIC causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined Cases of MTC in patients treated with liraglutide, another GLP-1 receptor agonist, have been reported in the postmarketing period; the data in these reports are insufficient to establish or exclude a causal relationship between MTC and GLP-1 receptor agonist use in humans. OZEMPIC is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2 Counsel patients regarding the potential risk for MTC with the use of OZEMPIC and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness).
Key Points:
- Semaglutide may increase the risk of thyroid C-cell tumors, including medullary thyroid carcinoma (MTC).
- The drug 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 counseled about the potential risk of MTC and informed of symptoms of thyroid tumors.
- The human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined 1.
From the Research
Semaglutide should be used with caution in patients with thyroid conditions, and it is contraindicated in those with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2. When considering semaglutide for patients with thyroid conditions, it is essential to consult with a healthcare provider first. According to the study by 2, semaglutide has not been shown to cause thyroid problems in humans, although there were concerns from animal studies. The risk of thyroid problems appears minimal in humans without a personal or family history of multiple endocrine neoplasia syndrome type 2 (MEN 2) or medullary thyroid cancer.
Key Considerations
- For patients with hypothyroidism who are stable on thyroid medication, semaglutide can generally be used safely, but thyroid function should be monitored as weight loss itself can affect thyroid hormone requirements 3.
- The study by 3 also found that co-administration of oral semaglutide with levothyroxine affects thyroxine exposure, and monitoring of thyroid parameters should be considered when treating patients with both oral semaglutide and levothyroxine.
- Semaglutide works by mimicking GLP-1, a hormone that regulates blood sugar and appetite, which is why it can help with weight loss and diabetes management without directly affecting thyroid function in most people.
Administration and Dosage
- The typical starting dose of semaglutide for weight management is 0.25 mg weekly by injection, gradually increasing to a target dose of 2.4 mg weekly.
- For diabetes management, the maximum dose is usually 1 mg weekly.
- Oral semaglutide should be taken on an empty stomach upon waking with a sip (≤120 mL) of plain water and at least 30 minutes before the first food, beverage, or other oral medications of the day 4.