Wegovey Safety Information

### Important Safety Information**WEGOVY® (semaglutide)** is a 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.
- 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.
- Limited experience in patients with a history of pancreatitis. The risk is unknown.**IMPORTANT SAFETY INFORMATION****WARNING: RISK OF THYROID C-CELL TUMORS**
- In rodents, semaglutide causes thyroid C-cell tumors. The relevance to humans is unknown.
- WEGOVY® is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients about the potential risk of MTC and symptoms of thyroid tumors.**Do not take WEGOVY® if you:**
- Have a personal or family history of MTC or MEN 2.
- Have been diagnosed with Type 1 diabetes.
- Have pancreatitis or a history of pancreatitis.
- Have severe gastrointestinal problems, such as gastroparesis.
- Are allergic to semaglutide or any inactive ingredients in WEGOVY® (di-sodium phosphate dihydrate, sodium chloride, water for injection, hydrochloric acid, or sodium hydroxide).
- Have a history of suicidal attempts or active suicidal ideation.**WARNINGS AND PRECAUTIONS**
- **Acute Pancreatitis:** Discontinue if suspected. Do not restart if confirmed.
- **Acute Gallbladder Disease:** Conduct studies and follow-up if cholelithiasis is suspected.
- **Hypoglycemia:** Risk increases with insulin secretagogues or insulin. Educate patients on signs and symptoms.
- **Acute Kidney Injury:** Monitor renal function when initiating or escalating doses.
- **Hypersensitivity Reactions:** Discontinue if suspected and seek medical advice.
- **Reproductive Potential:** Discontinue at least 2 months before planned pregnancy.
- **Pregnancy:** May cause fetal harm. Discontinue immediately if pregnancy is recognized.
- **Diabetic Retinopathy:** Monitor patients with a history of retinopathy.
- **Heart Rate Increase:** Monitor heart rate regularly.
- **Suicidal Behavior and Ideation:** Monitor for depression or suicidal thoughts. Discontinue if symptoms develop.**Side Effects**
- Most common side effects (incidence ≥ 5%) include nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, abdominal distension, eructation, hypoglycemia in type 2 diabetes patients, flatulence, gastroenteritis, gastroesophageal reflux disease, and nasopharyngitis.**To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch****DRUG INTERACTIONS**
- WEGOVY® delays gastric emptying, which may impact the absorption of oral medications. Use with caution.**USE IN SPECIFIC POPULATIONS**
- **Pregnancy:** May cause fetal harm. Discontinue if pregnancy is recognized.
- **Reproductive Potential:** Discontinue at least 2 months before planned pregnancy due to the long half-life of semaglutide.