Intended Use:
Mounjaro® (tirzepatide) is a once-weekly injectable prescription medication indicated for use in adults with type 2 diabetes mellitus to improve glycemic control, in conjunction with diet and exercise. Off-label, it may also be prescribed for weight management in patients who meet specific medical criteria, such as obesity or overweight with associated comorbidities.

Contraindications:
Do not use Mounjaro® if:

• You or any family member has a history of medullary thyroid carcinoma (MTC)
• You have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
• You are allergic to tirzepatide or any of the product’s ingredients
  
  

Warnings & Serious Risks:

• Thyroid tumors, including cancer: Animal studies have shown a risk of thyroid C-cell tumors. It is not known whether this risk applies to humans.
• Pancreatitis: Report severe abdominal pain, with or without vomiting, to your healthcare provider immediately.
• Gallbladder disease: Mounjaro® has been associated with gallstones and inflammation of the gallbladder.
• Kidney issues: Gastrointestinal side effects like nausea, vomiting, and diarrhea may lead to dehydration, worsening kidney function.
• Hypoglycemia (low blood sugar): Especially when combined with insulin or sulfonylureas.
• Serious allergic reactions: Discontinue use and seek emergency care if you experience swelling, difficulty breathing, or rash.
• Diabetic retinopathy complications: Monitor vision changes and consult your provider.
• Suicidal ideation or mood changes: Report any new or worsening mental health symptoms.
  
  

Common Side Effects:

• Nausea
• Diarrhea
• Vomiting
• Constipation
• Decreased appetite
• Abdominal discomfort
• Injection site reactions
• Fatigue
• Indigestion

These symptoms are often mild and may decrease with continued use.

Drug Interactions:
Mounjaro® may slow gastric emptying and affect the absorption of oral medications. Caution is advised when used with:

• Insulin or insulin secretagogues (e.g., sulfonylureas)
• Medications with narrow therapeutic indices
• Oral contraceptives (alternative contraception may be advised for 4 weeks after starting or increasing the dose)
  
  

Pregnancy & Breastfeeding:

• Not recommended during pregnancy. Discontinue at least 2 months before planned conception.
• It is unknown whether Mounjaro® is excreted in human breast milk. Avoid use while breastfeeding unless deemed necessary by your provider.
  
  

Administration:
Inject subcutaneously once weekly in the abdomen, thigh, or upper arm. Do not mix with insulin in the same injection. Rotate injection sites weekly.

Storage:
Store Mounjaro® pens in the refrigerator (36°F to 46°F / 2°C to 8°C). Do not freeze. Protect from light. If necessary, pens can be stored at room temperature (up to 86°F / 30°C) for up to 21 days.

Emergency Situations:
Seek immediate medical attention if you experience signs of severe allergic reaction, persistent vomiting, symptoms of pancreatitis, or hypoglycemia. Call 911 or visit the nearest emergency room.

Disclaimer:
This information is intended for educational purposes only and does not replace professional medical advice. Always consult your healthcare provider before starting, stopping, or changing medications. Report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.