Indicated for:

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

• To reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease.

OZEMPIC 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.

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

OZEMPIC is not a substitute for insulin. OZEMPIC 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.

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 (MEN2). 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). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with OZEMPIC.

The maximum recommended dosage is 1 mg once weekly.

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

In a 2-year trial involving patients with type 2 diabetes and high cardiovascular risk, more events of diabetic retinopathy complications occurred in patients treated with OZEMPIC compared to placebo.

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.

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

The risk of hypoglycemia is increased when OZEMPIC is used in combination with insulin secretagogues (e.g., sulfonylureas) or insulin.

Acute events of gallbladder disease such as cholelithiasis or cholecystitis have been reported in GLP-1 receptor agonist trials and postmarketing. In placebo-controlled trials, cholelithiasis was reported in 1.5% and 0.4% of patients-treated with OZEMPIC 0.5 mg and 1 mg, respectively. Cholelithiasis was not reported in placebo- treated patients. If cholelithiasis is suspected, gallbladder studies and appropriate clinical follow-up are indicated.

Consistent with the potentially immunogenic properties of protein and peptide pharmaceuticals, patients treated with OZEMPIC may develop anti-semaglutide antibodies. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay.

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

There are limited data with semaglutide use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. Animal studies: embryo-fetal mortality, structural abnormalities and alterations to growth occurred at maternal exposures below the maximum recommended human dose (MRHD) based on AUC. 

There are no data on the presence of semaglutide in human milk, the effects on the breastfed infant, or the effects on milk production. Semaglutide was present in the milk of lactating rats, however, due to species-specific differences in lactation physiology, the clinical relevance of these data are not clear.

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• Dosage greater than 1 mg once weekly. GoToSource

• Use in patients under the age of 18. GoToSource

• First-line therapy. GoToSource

Hypoglycemia (low blood sugar), nasopharyngitis and gastrointestinal disorders (nausea, vomiting, diarrhea, abdominal discomfort and decreased appetite). GoToSource

Development of anti-semaglutide antibodies. GoToSource

Pancreatitis (inflammation of the pancreas), cholelithiasis (presence or formation of gallstones antibody formation), acute kidney failure and retinopathy complications (vitreous hemorrhage, blindness). GoToSource

Thyroid cancer. GoToSource

Lawsuits filed for pancreatitis and thyroid cancer.