Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

RYBELSUS is not recommended as a first-line therapy for patients who have inadequate glycemic control on diet and exercise because of the uncertain relevance of rodent C-cell tumor findings to humans.

RYBELSUS has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis.

RYBELSUS is not indicated for use in patients with type 1 diabetes mellitus or for the treatment of patients with diabetic ketoacidosis, as it would not be effective in these settings.

RYBELSUS is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

 Counsel patients regarding the potential risk for MTC with the use of RYBELSUS and inform them of symptoms of thyroid tumors (e.g. a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with RYBELSUS.

In rodents, semaglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether RYBELSUS 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.

Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy. The effect of long-term glycemic control with semaglutide on diabetic retinopathy complications has not been studied. Patients with a history of diabetic retinopathy should be monitored for progression of diabetic retinopathy.

The risk of hypoglycemia is increased when RYBELSUS is used in combination with insulin secretagogues (e.g., sulfonylureas) or insulin. Patients may require a lower dose of the secretagogue or insulin to reduce the risk of hypoglycemia in this setting.

There have been postmarketing reports of acute kidney injury and worsening of chronic renal failure, which may sometimes require hemodialysis, in patients treated with GLP-1 receptor agonists, including semaglutide.

Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported with GLP-1 receptor agonists, including semaglutide.

Consistent with the potentially immunogenic properties of protein and peptide pharmaceuticals, patients treated with RYBELSUS may develop anti-semaglutide antibodies.

RYBELSUS causes a delay of gastric emptying, and thereby has the potential to impact the absorption of other oral medications.

Available data with RYBELSUS use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Animal studies: embryofetal mortality, structural abnormalities and alterations to growth.

Discontinue RYBELSUS in women at least 2 months before a planned pregnancy due to the long washout period for semaglutide.

Because of the unknown potential for serious adverse reactions in the breastfed infant due to the possible accumulation of SNAC from breastfeeding and because there are alternative formulations of semaglutide that can be used during lactation, advise patients that breastfeeding is not recommended during treatment with RYBELSUS.

GoToSource

• Use in patients under 18 years of age. GoToSource

• Type 1 diabetes. GoToSource

• Nonalcoholic steatohepatitis. GoToSource

Pancreatitis (inflammation of pancreas). GoToSource

Diabetic retinopathy (damage to blood vessels of retina). GoToSource

Thyroid c-cell tumors, hypoglycemia (low blood sugar) and hypersensitivity reactions. GoToSource

No major injury lawsuits reported.