Wegovy^® (semaglutide) injection 1.7 mg or 2.4 mg and Wegovy^® (semaglutide) tablets 25 mg are indicated in combination with a reduced calorie diet and increased physical activity 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
• Reduce excess body weight and maintain weight reduction long term in adults with obesity or overweight in the presence of at least one weight-related comorbidity

Wegovy^® (semaglutide) injection 1.7 mg or 2.4 mg is indicated in combination with a reduced calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in pediatric patients aged 12 and older with obesity

Concomitant use of Wegovy^® tablets or 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 or severe abdominal pain, (sometimes radiating to the back), and which may or may not be accompanied by nausea, or vomiting. If 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 Wegovy^® injection-treated adults. In clinical trials in adult patients, cholelithiasis was reported by 1.6% of Wegovy^® injection-treated patients and 0.7% of placebo treated patients, and by 2.5% of Wegovy^® tablet-treated patients and 1% of placebo treated patients. Cholecystitis was reported by 0.6% of Wegovy^® injection-treated adult patients and 0.2% of placebo treated 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 ≥ to 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 or tablet was used concomitantly with insulin or an insulin secretagogue (e.g., sulfonylurea). Patients with diabetes taking Wegovy^® with an insulin or insulin secretagogue (e.g. sulfonylurea) 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^® than placebo. Severe GI adverse reactions were reported in 4.1% and 0.9% of Wegovy^®-injection treated and placebo treated patients, respectively, and in 2% of Wegovy^® tablet-treated and 0% of placebo treated patients, respectively. 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 Type 2 Diabetes: In a trial of adult patients with T2D and BMI ≥ to 27 kg/m², diabetic retinopathy was reported by 4% of Wegovy^® injection-treated patients and 2.7% of placebo patients. In a glycemic control trial evaluating a dose comparable to the 9 mg dose and the 25 mg semaglutide tablet doses in patients with T2D, 1.3% and 1.9% of patients in the 9 mg and 25 mg semaglutide group, respectively, reported moderate-severe non-proliferative diabetic retinopathy events, and 0% and 0.4% reported proliferative retinopathy events, respectively. 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%). Findings were similar in a trial with the Wegovy^® tablets. 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^®
• Suicidal Behavior and Ideation: Suicidal behavior and ideation have been reported in clinical trials with other weight management products. Monitor patients for depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Discontinue Wegovy^® in patients who experience suicidal thoughts or behaviors and avoid in patients with a history of suicidal attempts or active suicidal ideation
• 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^®

• Most common adverse reactions (incidence ≥5%) are: nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, abdominal distention, eructation, hypoglycemia in patients with type 2 diabetes, flatulence, gastroenteritis, gastroesophageal reflux disease, and nasopharyngitis

• When initiating Wegovy^®, consider reducing the dose of concomitantly administered insulin secretagogues (such as sulfonylureas) 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
• Lactation: A clinical lactation study reported semaglutide concentrations below the lower limit of quantification in human breast milk. However, salcaprozate sodium (SNAC) and/or its metabolites are present in human milk. Because of the unknown potential for serious adverse reactions in the breastfed infant due to the possible accumulation of SNAC, an absorption enhancer for Wegovy^® tablets, and because there are alternative formulations of semaglutide that do not contain SNAC that can be used during lactation, advise patients that breastfeeding is not recommended during treatment with Wegovy^® tablets
• Pediatric: Adverse reactions with Wegovy^® injection-treated pediatric patients ≥12 years with obesity were similar to those reported in adults. Pediatric patients ≥12 years of age 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^® injection 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 or to reduce excess body weight and maintain weight reduction long term in those <12 years of age.
  
  The safety and effectiveness of Wegovy^® tablets have not been established in pediatric patients
• Geriatric: In the CV outcomes trial, patients ≥75 years reported more hip and pelvis fractures on Wegovy^® injection than placebo.  Patients ≥75 years (Wegovy^® injection and placebo) reported more serious adverse reactions overall compared to younger adult patients
• Type 2 Diabetes: Wegovy^® tablets have not been studied for weight reduction in adults with T2D and obesity or overweight. 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.