What are the contraindications for Mounjaro (tirzepatide)?

Contraindications for Mounjaro (Tirzepatide)

Mounjaro is absolutely contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), and in those with known serious hypersensitivity to tirzepatide or any excipients. 1

Absolute Contraindications

Thyroid C-Cell Tumor Risk

• Do not prescribe tirzepatide to any patient with a personal or family history of medullary thyroid carcinoma (MTC). 1
• Do not prescribe tirzepatide to patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). 1
• This contraindication stems from rodent studies showing dose-dependent thyroid C-cell tumors at clinically relevant exposures, though human relevance remains uncertain. 1

Hypersensitivity Reactions

• Tirzepatide is contraindicated in patients with known serious hypersensitivity to tirzepatide or any excipients in the formulation. 1
• Serious hypersensitivity reactions including anaphylaxis and angioedema have been documented with tirzepatide use. 1

Critical Screening Before Initiation

Pre-Treatment Assessment

• Screen all patients for personal or family history of MTC before prescribing. 1
• Screen for history of MEN 2 syndrome before prescribing. 1
• Counsel patients about symptoms of thyroid tumors including neck mass, dysphagia, dyspnea, and persistent hoarseness. 1

Important Caveat on Monitoring

• Routine serum calcitonin monitoring or thyroid ultrasound is of uncertain value for early MTC detection in patients treated with tirzepatide. 1

Populations Requiring Extreme Caution (Not Absolute Contraindications)

Gastrointestinal Disease

• Tirzepatide has not been studied in patients with severe gastrointestinal disease and is not recommended in these patients. 2, 1
• The medication is not recommended for patients with a history of pancreatitis, as it has not been studied in this population. 2, 1

Renal Impairment

• Use caution when initiating or increasing doses in patients with kidney disease due to increased risk of acute kidney injury from dehydration secondary to gastrointestinal side effects. 2

Diabetic Retinopathy

• Tirzepatide has not been studied in patients with non-proliferative diabetic retinopathy requiring acute therapy, proliferative diabetic retinopathy, or diabetic macular edema. 1

Common Pitfalls to Avoid

• Do not assume the black box warning about thyroid C-cell tumors is merely theoretical—this is an absolute contraindication requiring thorough family history assessment. 1
• Do not confuse cautions with contraindications—only MTC/MEN 2 history and serious hypersensitivity are true contraindications per FDA labeling. 1
• Gastrointestinal adverse events are dose-dependent (39% at 5mg, 46% at 10mg, 49% at 15mg), so severe GI disease warrants avoiding this medication entirely. 3