Indications and Limitations of Use

Wegovy® (semaglutide) injection 2.4 mg is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in:

• Adults with an initial body mass index (BMI) of ≥30 kg/m² (obesity), or ≥27 kg/m² (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia).
• Pediatric patients aged 12 years and older with an initial BMI at the 95th percentile or greater for age and sex (obesity).

Wegovy® is not indicated for use in patients with type 1 diabetes mellitus.

Important Safety Information

Contraindications

• Wegovy® 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), and in patients with a hypersensitivity reaction to semaglutide or to any of the excipients in Wegovy®. Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with Wegovy®.

Warnings and Precautions

• Risk of Thyroid C-Cell Tumors: Patients should be referred to an endocrinologist for further evaluation if serum calcitonin is measured and found to be elevated, or if thyroid nodules are noted on physical examination or neck imaging.
• Pancreatitis: Acute pancreatitis has been reported in clinical studies. Observe patients carefully for signs and symptoms of pancreatitis (persistent severe abdominal pain, sometimes radiating to the back, with or without vomiting). If pancreatitis is suspected, discontinue Wegovy® promptly, and if confirmed, do not restart.
• Diabetic Retinopathy Complications in Patients with Type 2 Diabetes:
  Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy. Monitor patients with a history of diabetic retinopathy for progression.
• Never Share a Wegovy® Pen Between Patients: Wegovy® pens must never be shared between patients, even if the needle is changed. Pen-sharing poses a risk for transmission of blood-borne pathogens.
• Hypoglycemia with Concomitant Use of Anti-Diabetic Therapy: Patients receiving Wegovy® in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia. Inform patients using these concomitant medications of the risk of hypoglycemia and educate them on the signs and symptoms.
• Acute Kidney Injury: 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. Some events have been reported in patients without known underlying renal disease. A majority occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. Monitor renal function when initiating or escalating doses of Wegovy® in patients reporting severe adverse gastrointestinal reactions.
• Hypersensitivity: Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported in patients treated with Wegovy®. If hypersensitivity reactions occur, discontinue use of Wegovy®; treat promptly per standard of care, and monitor until signs and symptoms resolve. Use caution in patients with a history of angioedema or anaphylaxis with another GLP-1 receptor agonist.
• Acute Gallbladder Disease: Acute events of gallbladder disease, such as cholelithiasis or cholecystitis, have been reported in GLP-1 receptor agonist trials and postmarketing. If cholelithiasis is suspected, gallbladder studies and appropriate clinical follow-up are indicated.

Adverse Reactions

The most common adverse reactions, reported in ≥5% of patients treated with Wegovy®, are nausea, vomiting, diarrhea, abdominal pain, and constipation.

Drug Interactions

• When initiating Wegovy®, consider reducing the dose of concomitantly administered insulin secretagogues (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia.
• Wegovy® delays gastric emptying and has the potential to impact the absorption of concomitantly administered oral medications. Caution should be exercised.

Use in Specific Populations

• There are limited data with semaglutide use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. Discontinue Wegovy® in women at least 2 months before a planned pregnancy due to the long washout period for semaglutide.