Mounjaro is not a substitute for insulin. Mounjaro should not be used in patients with type 1 diabetes mellitus (formerly known as insulin-dependent diabetes mellitus or IDDM).
Mounjaro has not been studied in combination with short-acting, medium-acting, or dual formulation insulins.
Mounjaro should not be used to treat diabetic ketoacidosis.
The safety and efficacy of Mounjaro have not been studied in pediatric patients. Mounjaro is not indicated for use in pediatric patients.
- Personal or family history of Medullary Thyroid Carcinoma (MTC), or Multiple Endocrine Neoplasia Syndrome Type 2 (MEN 2)
- Pregnancy or breastfeeding
Most serious warnings and precautions:
Risk of thyroid C-cell tumours: In both genders of rats, tirzepatide causes dose-dependent and treatment-dependent thyroid C-cell tumours. Patients should be counselled regarding the risk and symptoms of thyroid tumours.
Other relevant warnings and precautions:
- Should not be administered intramuscularly
- CV effects: Increased heart rate
- Hypoglycemia with concomitant use of insulin secretagogues or insulin
- Use with other incretin drugs
- Cholelithiasis or cholecystitis
- Hepatic insufficiency
- Diabetic retinopathy: In patients with history of disease, monitor for progression
- Acute kidney injury: Severe GI adverse reactions warrant monitoring of renal function when initiating or escalating doses
- Women of childbearing potential