Mounjaro®

Prescribing information and black box warning

Warnings:

• Thyroid Tumors (including Medullary Thyroid Carcinoma): Mounjaro® may increase the risk of thyroid C-cell tumors. It is not recommended for patients with a personal or family history of medullary thyroid carcinoma (MTC) or patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Do Not Use Mounjaro®  If:

• You have a history of severe allergic reactions to tirzepatide or any of its components.

• You have or have had medullary thyroid carcinoma or MEN 2.

• You are pregnant or planning to become pregnant.

Before Using Mounjaro® , Tell Your Doctor If:

• You have a history of pancreatitis, gallbladder disease, or gastrointestinal disorders.

• You have severe kidney or liver problems.

• You are taking other medications for diabetes or weight management, as this may increase the risk of hypoglycemia (low blood sugar).

• You are breastfeeding or planning to breastfeed.

Potential Side Effects:

• The most common side effects include nausea, vomiting, diarrhea, decreased appetite, constipation, and abdominal pain.

• Serious side effects may include pancreatitis, low blood sugar (especially when combined with insulin or sulfonylureas), and gallbladder problems.

Administration:

• Mounjaro® is an injectable medication given once weekly. Always follow the dosing and administration instructions provided by your healthcare provider.

Note: This medication is not intended for use in pediatric patients or individuals under 18 years of age.

Emergency Information:

• Seek immediate medical attention if you experience symptoms of an allergic reaction (e.g., rash, difficulty breathing, or swelling of the face/throat), severe stomach pain, or signs of low blood sugar (e.g., confusion, sweating, or shakiness).

For more information, consult your healthcare provider or review the full Prescribing Information and Medication Guide provided with your prescription.

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