Mounjaro®

Your safety is our first priority. Learn more about key medication details, side effects, and other important info about your treatment.

Prescribing information
Common Side effects

  • Nausea

  • Diarrhea

  • Vomiting

  • Decreased appetite

  • Constipation

  • Dyspepsia

  • Abdominal pain

Important safety information

MOUNJARO® (tirzepatide) is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist indicated as:

  • an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitations of Use:

  • Co-administration with other tirzepatide-containing products or GLP-1 receptor agonist is not recommended.

  • MOUNJARO® has not been studied in patients with a history of pancreatitis.

  • MOUNJARO® is not indicated for use in patients with type 1 diabetes mellitus.

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning.

  • Tirzepatide causes thyroid C-cell tumors in rats. It is unknown whether MOUNJARO® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as the human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined.

  • 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). Counsel patients regarding the potential risk of MTC and symptoms of thyroid tumors.

Do not use MOUNJARO® if you:

  • Have a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN2).

  • Have been diagnosed with Diabetes (Type 1)

  • Have been diagnosed with pancreatitis or history of pancreatitis

  • Have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis), or problems with digesting food

  • Have a known allergy to tirzepatide/any other GLP-1 drug, or any of the inactive ingredients in MOUNJARO®. Inactive ingredients include: sodium chloride, sodium phosphate dibasic heptahydrate, and water for injection. Hydrochloric acid solution and/or sodium hydroxide solution may have been added to adjust the pH

WARNINGS AND PRECAUTIONS

  • Pancreatitis: Has been reported in clinical trials. Discontinue promptly if pancreatitis is suspected

  • Acute Gallbladder Disease: Has occurred in clinical trials. If cholelithiasis is suspected, gallbladder studies and clinical follow-up are indicated

  • Severe Gastrointestinal Disease: Use may be associated with gastrointestinal adverse reactions, sometimes severe. Has not been studied in patients with severe gastrointestinal disease and is not recommended in these patients

  • Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin: Concomitant use with an insulin secretagogue or insulin may increase the risk of hypoglycemia. Reducing the dose of insulin secretagogue or insulin may be necessary

  • Acute Kidney Injury: Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions

  • Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis and angioedema) have been reported. Discontinue MOUNJARO® if suspected and promptly seek medical advice

  • Females of Reproductive Potential: Advise females using oral contraceptives to switch to a non-oral contraceptive method, or add a barrier method of contraception for 4 weeks after initiation and for 4 weeks after each dose escalation

  • Females of Reproductive Potential: Discontinue MOUNJARO® at least 2 months before a planned pregnancy because of the long half-life of tirzepatide

  • Pregnancy: Based on animal study, may cause fetal harm. When pregnancy is recognized, discontinue MOUNJARO® immediately

  • Diabetic Retinopathy Complications in Patients with a History of Diabetic Retinopathy: Has not been studied in patients with nonproliferative diabetic retinopathy requiring acute therapy, proliferative diabetic retinopathy, or diabetic macular edema. Monitor patients with a history of diabetic retinopathy for progression

  • Pulmonary Aspiration During General Anesthesia or Deep Sedation: Has been reported in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures. Instruct patients to inform healthcare providers of any planned surgeries or procedures

Side Effects Most common side effects (incidence ≥ 5%) of patients treated with MOUNJARO®: nausea, diarrhea, vomiting, decreased appetite, constipation, dyspepsia, and abdominal pain

To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

DRUG INTERACTIONS MOUNJARO® delays gastric emptying. May impact absorption of concomitantly administered oral medications. Use with caution.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: May cause fetal harm. When pregnancy is recognized, discontinue MOUNJARO®

  • Females of Reproductive Potential: Advise females using oral contraceptives to switch to a non-oral contraceptive method, or add a barrier method of contraception for 4 weeks after initiation and for 4 weeks after each dose escalation

  • Females and Males of Reproductive Potential: Discontinue MOUNJARO® at least 2 months before a planned pregnancy because of the long half-life of MOUNJARO®