Tirzepatide

Important Safety Information

Important Safety Information

Tirzepatide is a dual GIP/GLP-1 receptor agonist 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:

27 kg/m² or greater (overweight or obesity)

Limitations of Use:

• Co-administration with other GIP/GLP-1 receptor agonists or any similar compounds is not recommended.
• The safety and efficacy of tirzepatide for weight management have not been established in combination with other products.
• Tirzepatide has not been studied in patients with a history of pancreatitis.

WARNING: RISK OF THYROID C-CELL TUMORS

• In animal studies, tirzepatide has caused thyroid C-cell tumors at clinically relevant exposures. It is unknown whether tirzepatide causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans. The relevance of these findings to humans remains uncertain.
• Tirzepatide 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 on the potential risk of MTC and the symptoms of thyroid tumors.

Do not take tirzepatide 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 pancreatitis or have a history of pancreatitis.
• Are allergic to tirzepatide or any of its inactive ingredients.
• Have a history of suicidal attempts or active suicidal ideation.

WARNINGS AND PRECAUTIONS

• Acute Pancreatitis: Discontinue tirzepatide promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed.
• Acute Gallbladder Disease: Gallbladder disease has been observed in clinical trials. Clinical follow-up and further studies are indicated if gallbladder issues are suspected.
• Hypoglycemia: Concomitant use with insulin or insulin secretagogues may increase the risk of hypoglycemia. Dose adjustments of insulin or insulin secretagogues may be necessary.
• Acute Kidney Injury: Monitor renal function when initiating or increasing doses in patients reporting severe gastrointestinal side effects.
• Hypersensitivity Reactions: Discontinue tirzepatide if hypersensitivity reactions such as anaphylaxis or angioedema occur and seek medical attention.
• Pregnancy: Tirzepatide may cause fetal harm. Discontinue the medication immediately upon recognizing pregnancy.
• Diabetic Retinopathy Complications: Patients with a history of diabetic retinopathy should be monitored closely.
• Heart Rate Increase: Monitor heart rate periodically.
• Suicidal Behavior and Ideation: Monitor for symptoms of depression or suicidal thoughts and discontinue if these symptoms develop.

Side Effects Most common side effects (incidence ≥ 5%) include:

• Nausea
• Diarrhea
• Vomiting
• Constipation
• Abdominal pain
• Fatigue
• Dyspepsia (indigestion)
• Dizziness
• Abdominal distension
• Gastroesophageal reflux disease (GERD)
• Headache

Drug Interactions Tirzepatide delays gastric emptying and may impact the absorption of oral medications. Use with caution.

Use in Specific Populations

• Pregnancy: May cause fetal harm. Discontinue tirzepatide as soon as pregnancy is detected.
• Females and Males of Reproductive Potential: Discontinue tirzepatide at least 2 months before a planned pregnancy due to its long half-life.

Reporting Adverse Reactions To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.