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Wegovy Prescribing Information
• 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[see Warnings and Precautions (.5.1), Nonclinical Toxicology (13.1)]• 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)[see Contraindications (. 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 WEGOVY4)][see Contraindications (.4), Warnings and Precautions (5.1)]
Indications and Usage …..……………………………………08/2025
Dosage and Administration,
Recommended Dosage Initiation and Escalation Schedule,
Recommended Maintenance Dosage
Clinical Studies ].
Noncirrhotic MASH with Moderate to Advanced Liver Fibrosis
• The recommended maintenance dosage of WEGOVY for the treatment of noncirrhotic MASH with moderate to advanced liver fibrosis is 2.4 mg injected subcutaneously once weekly.• If patients do not tolerate the maintenance dosage of 2.4 mg once weekly, the dosage can be decreased to 1.7 mg once weekly. Consider reescalation to 2.4 mg once weekly[see Adverse Reactions , Clinical Studies ].
Warnings and Precautions,
5.5 Acute Kidney Injury Due to Volume DepletionThere 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
[see Adverse Reactions ].Monitor renal function in patients reporting adverse reactions to WEGOVY that could lead to volume depletion, especially during dosage initiation and escalation of WEGOVY.
5.6 Severe Gastrointestinal Adverse ReactionsUse of WEGOVY has been associated with gastrointestinal adverse reactions, sometimes severe[see Adverse Reactions(6)]. In WEGOVY clinical trials in adults for weight reduction, severe gastrointestinal adverse reactions were reported more frequently among patients receiving WEGOVY (4.1%) than placebo (0.9%). Severe gastrointestinal adverse reactions have also been reported postmarketing with GLP-1 receptor agonists.WEGOVY is not recommended in patients with severe gastroparesis.
5.11 Pulmonary Aspiration During General Anesthesia or Deep SedationWEGOVY delays gastric emptying[see Clinical Pharmacology (12.2)]. 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.Available data are insufficient to inform recommendations to mitigate the risk of pulmonary aspiration during general anesthesia or deep sedation in patients taking WEGOVY, including whether modifying preoperative fasting recommendations or temporarily discontinuing WEGOVY could reduce the incidence of retained gastric contents. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking WEGOVY.
WEGOVY is 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.• to reduce excess body weight and maintain weight reduction long term in:o Adults and pediatric patients aged 12 years and older with obesityo Adults with overweight in the presence of at least one weight-related comorbid condition.• 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
[see Clinical Studies (14.4)]
. Continued approval for this indication may be contingent upon the verification and description of clinical benefit in a confirmatory trial.Limitations of Use
WEGOVY contains semaglutide. Coadministration with other semaglutide-containing products or with any other GLP-1 receptor agonist is not recommended.
• Administer WEGOVY once-weekly as an adjunct to diet and increased physical activity, on the same day each week, at any time of day, with or without meals.• Inject subcutaneously in the abdomen, thigh, or upper arm.• In patients with type 2 diabetes, monitor blood glucose prior to starting and during WEGOVY treatment.• Initiate at 0.25 mg once-weekly for 4 weeks. Then follow the dosage escalation schedule, titrating every 4 weeks to achieve the maintenance dosage.• For patients with MASH, the maintenance dosage of WEGOVY is 2.4 mg once-weekly. If patients do not tolerate 2.4 mg once-weekly, the dosage can be decreased to 1.7 mg once-weekly. ()2.3 Recommended Maintenance DosageCardiovascular Risk Reduction and Weight Reduction• The maintenance dosage of WEGOVY for CV risk reduction and weight reduction is either 2.4 mg (recommended) or 1.7 mg injected subcutaneously once weekly.• Consider treatment response and tolerability when selecting the maintenance dosage[see Adverse Reactions,Clinical Studies ].
Noncirrhotic MASH with Moderate to Advanced Liver Fibrosis• The recommended maintenance dosage of WEGOVY for the treatment of noncirrhotic MASH with moderate to advanced liver fibrosis is 2.4 mg injected subcutaneously once weekly.• If patients do not tolerate the maintenance dosage of 2.4 mg once weekly, the dosage can be decreased to 1.7 mg once weekly. Consider reescalation to 2.4 mg once weekly[see Adverse Reactions , Clinical Studies ].
• For all other indications except for MASH treatment, the maintenance dosage of WEGOVY is either 2.4 mg (recommended) or 1.7 mg once-weekly. ()2.3 Recommended Maintenance DosageCardiovascular Risk Reduction and Weight Reduction• The maintenance dosage of WEGOVY for CV risk reduction and weight reduction is either 2.4 mg (recommended) or 1.7 mg injected subcutaneously once weekly.• Consider treatment response and tolerability when selecting the maintenance dosage[see Adverse Reactions,Clinical Studies ].
Noncirrhotic MASH with Moderate to Advanced Liver Fibrosis• The recommended maintenance dosage of WEGOVY for the treatment of noncirrhotic MASH with moderate to advanced liver fibrosis is 2.4 mg injected subcutaneously once weekly.• If patients do not tolerate the maintenance dosage of 2.4 mg once weekly, the dosage can be decreased to 1.7 mg once weekly. Consider reescalation to 2.4 mg once weekly[see Adverse Reactions , Clinical Studies ].
Injection: clear, colorless solution available in 5 prefilled, disposable, single-dose pens:
• 0.25 mg/0.5 mL• 0.5 mg/0.5 mL• 1 mg/0.5 mL• 1.7 mg/0.75 mL• 2.4 mg/0.75 mL
• Pregnancy:May cause fetal harm. For patients receiving WEGOVY for CV risk reduction or weight reduction, discontinue WEGOVY when pregnancy is recognized. For patients with MASH, use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
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