Wegovy® Safety Information

Wegovy® Your safety comes first. Review the key medication details, side effects, and important safety information about your treatment below.

Common Side Effects

• Nausea
• Diarrhea
• Vomiting

Prescribing Information

Black Box Warning

WEGOVY® (semaglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced-calorie diet and increased physical activity:

• To reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular 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
  • Adults with overweight in the presence of at least one weight-related comorbid condition.

Limitations of Use:

• Co-administration with other semaglutide-containing products or any GLP-1 receptor agonist is not recommended.
• The safety and efficacy of coadministration with other products for weight management have not been established.
• There is limited experience from clinical trials with WEGOVY® in patients with a history of pancreatitis. It is unknown if patients with a history of pancreatitis are at a higher risk for development of pancreatitis on WEGOVY®.
• 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. This indication 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.

Important Safety Information

WARNING: RISK OF THYROID C-CELL TUMORS — See full prescribing information for complete boxed warning.

• In rodents, semaglutide causes 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 the 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 of MTC and symptoms of thyroid tumors.

Do not take WEGOVY® if you:

• Have a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN2)
• Have been diagnosed with Type 1 Diabetes
• Have been diagnosed with pancreatitis or have a history of pancreatitis
• Have severe stomach problems, such as slowed stomach emptying (gastroparesis) or difficulty digesting food
• Have a known allergy to semaglutide, any other GLP-1 drug, or any inactive ingredients in WEGOVY®
  
  • Injectable WEGOVY® inactive ingredients: di-sodium phosphate dihydrate, sodium chloride, water for injection, and hydrochloric acid or sodium hydroxide (to adjust pH)
  • Oral WEGOVY® inactive ingredients: magnesium stearate and Salcaprozate sodium

Warnings and Precautions

• Acute Pancreatitis: Has occurred in clinical trials. Discontinue promptly if pancreatitis is suspected. Do not restart if confirmed.
• Acute Gallbladder Disease: Has occurred in clinical trials. If cholelithiasis is suspected, gallbladder studies and clinical follow-up are indicated.
• Hypoglycemia: Concomitant use with an insulin secretagogue or insulin may increase the risk of hypoglycemia. Reducing the dose of insulin secretagogue or insulin may be necessary. Patients should be educated on the signs and symptoms of hypoglycemia.
• Acute Kidney Injury: Has occurred. Monitor renal function when initiating or escalating doses in patients reporting severe gastrointestinal reactions, particularly those with renal impairment.
• Hypersensitivity Reactions: Anaphylactic reactions and angioedema have been reported postmarketing. Discontinue WEGOVY® if suspected and seek medical advice promptly.
• Reproductive Potential: Discontinue WEGOVY® at least 2 months before a planned pregnancy due to the long half-life of semaglutide.
• Pregnancy: May cause fetal harm. Discontinue WEGOVY® immediately when pregnancy is recognized.
• Diabetic Retinopathy: Complications have been reported in trials with WEGOVY®. Patients with a history of diabetic retinopathy should be monitored.
• Heart Rate Increase: Monitor heart rate at regular intervals.
• Pulmonary Aspiration During General Anesthesia or Deep Sedation: Has been reported in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation. Instruct patients to inform all healthcare providers of their WEGOVY® use before any planned surgeries or procedures.
• Acute Kidney Injury Due to Volume Depletion: Has occurred with WEGOVY® use. Monitor renal function in patients reporting adverse reactions that could lead to volume depletion (e.g., nausea, vomiting, diarrhea), particularly those with pre-existing renal impairment.

For Wegovy HD 7.2mg only:

• Dysesthesia: May include a "sunburn-like" feeling, tingling, crawling, or extreme sensitivity to touch, even without a visible rash. This is typically dose-related and self-limiting. Notify your Fridays provider if it becomes painful or interferes with sleep.
• Higher Incidence of GI Side Effects: Notify your Fridays provider if side effects become significant.
• Dehydration Risk: This dose slows gastric emptying further, increasing the risk of dehydration. Monitor for dark urine or lightheadedness and notify your Fridays provider if side effects become significant.

Side Effects

Most common side effects (incidence ≥5%) in adults or pediatric patients aged 12 years and older: dysesthesia, nausea, hair loss, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, abdominal distension, eructation, hypoglycemia in patients with type 2 diabetes, flatulence, gastroenteritis, gastroesophageal reflux disease, and nasopharyngitis.

To report suspected adverse reactions, contact Novo Nordisk Inc. at 1-833-934-6891 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

WEGOVY® delays gastric emptying and may impact absorption of concomitantly administered oral medications. Consider increased clinical or laboratory monitoring when used concomitantly with other oral medications that have a narrow therapeutic index or that require clinical monitoring. Use with caution.

Use in Specific Populations

• Pregnancy: May cause fetal harm. Discontinue WEGOVY® immediately when pregnancy is recognized.
  
  • Pregnant women exposed to WEGOVY® and healthcare providers are encouraged to contact Novo Nordisk at 1-877-390-2760 or www.wegovypregnancyregistry.com.
• Lactation: Breastfeeding is not recommended during treatment with WEGOVY® tablets. The developmental and health benefits of breastfeeding should be considered alongside the potential risks to the infant and to the mother from the underlying condition.
• Females and Males of Reproductive Potential: Discontinue WEGOVY® at least 2 months before a planned pregnancy due to the long half-life of semaglutide.

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