Mounjaro Injection
Generic name: tirzepatide
Dosage form: injection, solution
Medically reviewed by Drugs.com. Last updated on May 1, 2022.
On This Page
- Boxed Warning
- Indications and Usage
- Dosage and Administration
- Dosage Forms and Strengths
- Contraindications
- Warnings and Precautions
- Adverse Reactions/Side Effects
- Drug Interactions
- Use In Specific Populations
- Overdosage
- Description
- Clinical Pharmacology
- Nonclinical Toxicology
- Clinical Studies
- How Supplied/Storage and Handling
- Medication Guide
WARNING: RISK OF THYROID C-CELL TUMORS
- In both male and female rats, tirzepatide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether MOUNJARO causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined[see Warnings and Precautions (5.1) and Nonclinical Toxicology (13.1)].
- MOUNJARO is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)[see Contraindications (4)]. Counsel patients regarding the potential risk for MTC with the use of MOUNJARO and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with MOUNJARO[see Contraindications (4) and Warnings and Precautions (5.1)].
Indications and Usage for Mounjaro Injection
MOUNJARO™ is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations of Use
- MOUNJARO has not been studied in patients with a history of pancreatitis [see Warnings and Precautions (5.2)].
- MOUNJARO is not indicated for use in patients with type 1 diabetes mellitus.
