Medication Monitor

Generic Name (Trade Name—Company)
September 25, 2019

Semaglutide tablets

(Rybelsus—Novo Nordisk)
FDA approves first oral GLP-1 treatment for type 2 diabetes

FDA approval semaglutide tablets to improve control of blood glucose levels in adult patients with type 2 diabetes, along with diet and exercise. The agent is the first glucagon-like peptide (GLP-1) receptor protein treatment approved for use in the United States that does not need to be injected. 

The prescribing information includes a boxed warning about the potential increased risk of thyroid c-cell tumors, and that semaglutide oral tablets are not recommended as the first choice of medication for treating diabetes. Patients who have ever had medullary thyroid carcinoma (MTC) or who have a family member who has ever had MTC are advised not to use the medication. In addition, patients who have ever had multiple endocrine neoplasia syndrome type 2 are advised not to use it. The drug is not for use in patients with type 1 diabetes or diabetic ketoacidosis.

The prescribing information also has warnings about pancreatitis, diabetic retinopathy, hypoglycemia, acute kidney injury, and hypersensitivity reactions. 

The medication should be taken at least 30 minutes before the first food, beverage, or other oral medication of the day, with no more than 4 oz. of plain water. Because the medication slows digestion, patients should discuss other medications they are taking with their health care provider before starting it.

The most common adverse effects are nausea, diarrhea, vomiting, decreased appetite, indigestion, and constipation.