GLP-1 Safety Information

### Important Safety Information**GLP-1 Receptor Agonists** are a class of medications indicated as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management and to improve glycemic control in adults with type 2 diabetes mellitus.**Limitations of Use:**
- Co-administration with other GLP-1 receptor agonists is not recommended.
- The safety and efficacy of coadministration with other weight management products have not been established.
- There is 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, GLP-1 receptor agonists cause thyroid C-cell tumors at clinically relevant exposures. The relevance to humans is unknown.
- GLP-1 receptor agonists are 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 GLP-1 Receptor Agonists 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 any GLP-1 receptor agonist or any inactive ingredients in the medication.
- 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**
- GLP-1 receptor agonists delay 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 GLP-1 receptor agonists.