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Wegovy™ (semaglutide) injection 2.4 mg As an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adults with a BMI of ≥30 kg/m2 (obesity), or ≥27 kg/m2 (overweight) in the presence of a weight-related comorbidity. Click for Limitations of Use.
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Important Safety Information for Wegovy™ (semaglutide) injection 2.4 mg
WARNING: RISK OF THYROID C-CELL TUMORS
In rodents, semaglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether Wegovy™ 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.
Wegovy™ 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 Wegovy™ 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 Wegovy™.
Indications and Usage
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).
Limitations of Use
Wegovy™ contains semaglutide and should not be coadministered with other semaglutide-containing products or with any GLP-1 receptor agonist.
The safety and effectiveness of Wegovy™ in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.
Wegovy™ has not been studied in patients with a history of pancreatitis.
Important Safety Information cont.
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 semaglutide.
Warnings and Precautions
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 semaglutide. Acute pancreatitis was observed in patients treated with Wegovy™ in clinical trials. Observe patients carefully for signs and symptoms of acute pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back, and which may or may not be accompanied by vomiting). If acute pancreatitis is suspected, discontinue Wegovy™ promptly, and if acute pancreatitis is confirmed, do not restart.
Acute Gallbladder Disease: In clinical trials, cholelithiasis was reported by 1.6% of Wegovy™ patients and 0.7% of placebo patients. Cholecystitis was reported by 0.6% of Wegovy™ patients and 0.2% of placebo patients. 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 patients with type 2 diabetes, hypoglycemia was reported in 6.2% of Wegovy™ patients versus 2.5% of placebo patients. Patients with type 2 diabetes taking Wegovy™ with an insulin secretagogue (e.g. sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia. Inform patients of the risk of hypoglycemia and educate them on the signs and symptoms. Monitor blood glucose in patients with type 2 diabetes.
Acute Kidney Injury: There have been postmarketing reports of acute kidney injury and worsening of chronic renal failure, which in some cases required hemodialysis, in patients treated with semaglutide. Patients with renal impairment may be at a greater risk of acute kidney injury, but some events have been reported in patients without known underlying renal disease. A majority of the events occurred in patients who experienced nausea, vomiting, or diarrhea, leading to volume depletion. Monitor renal function when initiating or escalating doses of Wegovy™ in patients reporting severe adverse gastrointestinal reactions and in patients with renal impairment reporting any adverse reactions that could lead to volume depletion.
Hypersensitivity: Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported with semaglutide. 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 patients with type 2 diabetes, diabetic retinopathy was reported by 4.0% of Wegovy™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™ patients compared to placebo in clinical trials. More Wegovy™ patients compared with placebo had maximum changes from baseline of 10 to 19 bpm (41% versus 34%) and 20 bpm or more (26% versus 16%). 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.
The most common adverse reactions reported in ≥5% of patients treated with Wegovy™ are nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, abdominal distention, eructation, hypoglycemia in patients with type 2 diabetes, flatulence, gastroenteritis, and gastroesophageal reflux disease.
The addition of Wegovy™in patients treated with insulin has not been evaluated. When initiating Wegovy™, consider reducing the dose of concomitantly administered insulin secretagogues (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia.
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™.
Use in Specific Populations
Pregnancy: May cause fetal harm. When pregnancy is recognized, discontinue Wegovy™.Discontinue Wegovy™ in patients at least 2 months before a planned pregnancy.
Please click here for Wegovy™ Prescribing Information, including Boxed Warning.