From the Guidelines
Rybelsus (oral semaglutide) 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). It should not be used in patients with a history of serious hypersensitivity reactions to semaglutide or any of the product components. Rybelsus is also contraindicated during pregnancy as weight loss and reduced caloric intake may harm fetal development. Patients with type 1 diabetes should not use Rybelsus as it is only approved for type 2 diabetes. Caution is needed in patients with severe gastrointestinal disease, including gastroparesis, as Rybelsus may worsen these conditions. The medication should be used carefully in patients with a history of pancreatitis or with risk factors for pancreatitis. Patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m²) should use Rybelsus with caution due to limited experience in this population. These contraindications exist because semaglutide, as a GLP-1 receptor agonist, has been associated with thyroid C-cell tumors in rodent studies, can cause significant gastrointestinal side effects, and may affect kidney function in susceptible individuals, as noted in studies such as 1 and 1.
Some key points to consider when prescribing Rybelsus include:
- Contraindications: personal or family history of MTC or MEN 2, serious hypersensitivity reactions to semaglutide, pregnancy
- Caution in patients with: severe gastrointestinal disease, history of pancreatitis, severe renal impairment
- Monitoring for: gastrointestinal side effects, pancreatitis, kidney function
- Benefits: improved glycemic control, weight loss, potential cardiovascular benefits, as seen in studies such as 1, 1, and 1
- Potential risks: thyroid C-cell tumors, gastrointestinal side effects, kidney function impairment, as noted in studies such as 1.
Overall, Rybelsus can be a useful treatment option for patients with type 2 diabetes, but it is essential to carefully consider the potential benefits and risks and to monitor patients closely for any adverse effects, as recommended in guidelines such as those outlined in 1 and 1.
From the FDA Drug Label
The FDA drug label does not answer the question.
From the Research
Rybelsus Contraindications in Diabetes
The contraindications for Rybelsus (semaglutide) in patients with diabetes include:
- Personal or family history of medullary thyroid carcinoma 2, 3
- Multiple endocrine neoplasia syndrome type 2 2, 3
- History of pancreatitis, as semaglutide is not recommended in patients with suspected or confirmed pancreatitis 2
- Type 1 diabetes, as semaglutide is not indicated for this condition 2
- Pregnancy, as semaglutide is contraindicated in pregnant women 3
Warnings and Precautions
In addition to the contraindications, there are several warnings and precautions to consider when using Rybelsus:
- Risk of thyroid C-cell tumors, as semaglutide has been associated with an increased risk of these tumors 3, 4
- Risk of pancreatitis, as semaglutide has been associated with an increased risk of pancreatitis 3, 4
- Risk of acute kidney injury, as semaglutide has been associated with an increased risk of acute kidney injury 3, 4
- Risk of diabetic retinopathy, as semaglutide has been associated with an increased risk of diabetic retinopathy complications 4
Administration Instructions
To minimize the risk of gastrointestinal adverse events, patients should: