Wegovy^® (semaglutide) injection 2.4 mg is indicated in combination with a reduced calorie diet and increased physical activity:

• for the treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH), with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) in adults. The indication for MASH is approved under accelerated approval based on improvement of MASH and fibrosis. Continued approval for this indication may be contingent upon the verification and description of clinical benefit in a confirmatory trial.
• to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established CV disease and either obesity or overweight
• to reduce excess body weight and maintain weight reduction long term in adults and pediatric patients aged 12 years and older with obesity and adults with overweight in the presence of at least one weight-related comorbid condition

Concomitant use of Wegovy^® injection with other semaglutide-containing products or with any GLP-1 receptor agonist is not recommended

• Wegovy^® is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2, and in patients with a prior serious hypersensitivity reaction to semaglutide or to any of the excipients in Wegovy^®. Serious hypersensitivity reactions, including anaphylaxis and angioedema have been reported with Wegovy^®

• Risk of Thyroid C-Cell Tumors: Patients should be further evaluated if serum calcitonin is measured and found to be elevated or thyroid nodules are noted on physical examination or neck imaging
• Acute Pancreatitis: Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists, including Wegovy^®. Observe patients carefully for signs and symptoms of acute pancreatitis, which may include persistent severe abdominal pain (sometimes radiating to the back), and which may or may not be accompanied by nausea or vomiting. If acute pancreatitis is suspected, discontinue Wegovy^® and initiate appropriate management
• Acute Gallbladder Disease: Treatment with Wegovy^® is associated with an increased occurrence of cholelithiasis and cholecystitis. The incidence of cholelithiasis and cholecystitis was higher in Wegovy^® injection-treated pediatric patients aged ≥12 years than in injection-treated Wegovy^® adults. In clinical trials in adult patients for weight reduction, cholelithiasis was reported by 1.6% of Wegovy^® injection-treated patients and 0.7% of placebo patients. Cholecystitis was reported by 0.6% of Wegovy^® injection-treated patients and 0.2% of placebo patients. In a clinical trial in pediatric patients aged ≥12 years, cholelithiasis was reported by 3.8% of Wegovy^® injection-treated patients and 0% placebo treated patients. Cholecystitis was reported by 0.8% of Wegovy^® injection-treated pediatric patients and 0% placebo treated patients. Substantial or rapid weight loss can increase the risk of cholelithiasis; however, the incidence of acute gallbladder disease was greater in Wegovy^® patients than in placebo patients, even after accounting for the degree of weight loss. If cholelithiasis is suspected, gallbladder studies and appropriate clinical follow-up are indicated
• Hypoglycemia: Wegovy^® lowers blood glucose and can cause hypoglycemia. In a trial of Wegovy^® injection in adult patients with type 2 diabetes (T2D) and a BMI ≥27 kg/m², hypoglycemia was reported in more patients treated with Wegovy^® versus placebo. In glycemic control clinical trials, the risk of hypoglycemia was increased when semaglutide injection was used concomitantly with insulin or an insulin secretagogue (e.g., sulfonylurea). Patients with diabetes taking Wegovy^® with an insulin or insulin secretagogue may have an increased risk of hypoglycemia, including severe hypoglycemia. The use of Wegovy^® in patients with type 1 diabetes or in combination with insulin has not been evaluated. Inform patients of the risk of hypoglycemia and educate them on the signs and symptoms. Monitor blood glucose in patients with diabetes
• Acute Kidney Injury Due to Volume Depletion: There have been postmarketing reports of acute kidney injury, in some cases requiring hemodialysis, in patients treated with semaglutide. The majority of the reported events occurred in patients who experienced gastrointestinal reactions leading to dehydration such as nausea, vomiting, or diarrhea. Monitor renal function in patients reporting adverse reactions to Wegovy^® that could lead to volume depletion, especially during initiation and escalation of Wegovy^®
• Severe Gastrointestinal (GI) Adverse Reactions: Use of Wegovy^® has been associated with GI adverse reactions, sometimes severe. In adult clinical trials, severe GI adverse reactions were reported more frequently among patients receiving Wegovy^® injection (4.1%) than placebo (0.9%). Severe GI adverse reactions have also been reported postmarketing with GLP-1 receptor agonists. Wegovy^® is not recommended in patients with severe gastroparesis
• Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported 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 a patient with a history of anaphylaxis or angioedema with another GLP-1 receptor agonist
• Diabetic Retinopathy Complications in Patients with T2D: In a trial of adult patients with T2D and BMI ≥27 kg/m², diabetic retinopathy was reported by 4% of Wegovy^® injection-treated patients and 2.7% of placebo patients. Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy. Patients with a history of diabetic retinopathy should be monitored for progression of diabetic retinopathy
• Heart Rate Increase: Mean increases in resting heart rate of 1 to 4 beats per minute (bpm) were observed in Wegovy^® injection-treated adult patients compared to placebo in clinical trials. More adults treated with Wegovy^® injection compared with placebo had maximum changes from baseline of 10 to 19 bpm (41% vs 34%) and 20 bpm or more (26% vs 16%). In a clinical trial in pediatric patients aged ≥12 years with normal baseline heart rate, more patients treated with Wegovy^® injection compared to placebo had maximum changes in heart rate of 20 bpm or more (54% vs 39%). Monitor heart rate at regular intervals and instruct patients to report palpitations or feelings of a racing heartbeat while at rest. If patients experience a sustained increase in resting heart rate, discontinue Wegovy^®
• Pulmonary Aspiration During General Anesthesia or Deep Sedation: Wegovy^® delays gastric emptying. There have been rare postmarketing reports of pulmonary aspiration in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation who had residual gastric contents despite reported adherence to preoperative fasting recommendations. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking Wegovy^®
• Never Share Wegovy^® FlexTouch^® Between Patients: Wegovy^® FlexTouch^® must never be shared between patients, even if the needle is changed. Pen-sharing poses a risk for transmission of blood-borne pathogens

• Most common adverse reactions (incidence ≥5%) are: nausea, diarrhea, vomiting, constipation, abdominal pain, dysesthesia, headache, fatigue, dyspepsia, dizziness, abdominal distention, eructation, hypoglycemia in patients with T2D, flatulence, gastroenteritis, gastroesophageal reflux disease, and hair loss

• When initiating Wegovy^®, consider reducing the dose of concomitantly administered insulin secretagogues or insulin to reduce the risk of hypoglycemia. The addition of Wegovy^® in patients treated with insulin has not been evaluated
• Wegovy^® causes a delay of gastric emptying and has the potential to impact the absorption of concomitantly administered oral medications. Monitor the effects of oral medications concomitantly administered with Wegovy^®. Consider increased clinical or laboratory monitoring for medications that have a narrow therapeutic index or that require clinical monitoring

• Pregnancy: May cause fetal harm. When pregnancy is recognized, discontinue Wegovy^®. Discontinue Wegovy^® in patients at least 2 months before a planned pregnancy
• Pediatric: Adverse reactions with Wegovy^® in pediatric patients aged ≥12 years with obesity were similar to those reported in adults in weight reduction trials. Pediatric patients ≥12 years treated with Wegovy^® injection had greater incidences of cholelithiasis, cholecystitis, hypotension, rash, and urticaria compared to adults treated with Wegovy^®. There are insufficient data in pediatric patients with T2D treated with Wegovy^® for obesity to determine if there is an increased risk of hypoglycemia with Wegovy^® injection treatment similar to that reported in adults
  The safety and effectiveness of Wegovy^® injection have not been established in pediatric patients to reduce the risk of major adverse CV events, to reduce excess body weight and maintain weight reduction long term in those <12 years, or for the treatment of noncirrhotic MASH
• Geriatric: In the CV outcomes trial, patients ≥75 years reported more hip and pelvis fractures on Wegovy^® injection than placebo. Patients aged ≥75 years (Wegovy^® injection and placebo) reported more serious adverse reactions overall compared to younger adult patients
• Type 2 Diabetes: Administration of Wegovy^® injection resulted in less weight reduction in patients with T2D and obesity or overweight compared to those without T2D and obesity or overweight

Please see Wegovy^® Prescribing Information, including Boxed Warning.