Important Safety Information for Mounjaro (tirzepatide) Injection

Warning: Risk of Thyroid C-Cell Tumors

In rats, Mounjaro caused thyroid tumors, including thyroid cancer. It is not known if Mounjaro will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people. Notify your healthcare provider if you develop a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath, as these may be symptoms of thyroid cancer.

FDA-Approved Use of Mounjaro

Mounjaro is prescribed along with a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of:

• 30 kg/m2 or greater (obesity) or
• 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea, or cardiovascular disease).

Limitations of Use

• Mounjaro should not be used in combination with other tirzepatide-containing products or any other GLP-1 receptor agonist.
• The safety and efficacy of coadministration with other products for weight management have not been established.
• Mounjaro has not been studied in patients with a history of pancreatitis.

 

Who Should Not Use Mounjaro?

Do not use Mounjaro if:

• You or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• You have a known allergic reaction to Mounjaro.

 

How Should I Take Mounjaro?

Mounjaro can be taken with or without food. The pre-filled injector pen is self-administered as a subcutaneous injection in the stomach, thigh, or upper arm once a week on the same day every week. Your healthcare provider will guide you on a treatment regimen that may include an increase in dose every four weeks. Do not change your dosing regimen or stop taking Mounjaro as prescribed without consulting your provider first.

What Should I Tell My Healthcare Provider Before Using Mounjaro?

Inform your healthcare provider about all medications you are currently taking, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements. Some medications to watch out for include:

• Medications for diabetes: Medications used to treat type 1 or type 2 diabetes, including insulin or sulfonylureas.
• Other oral medications: Mounjaro causes a delay in gastric emptying, potentially impacting the absorption of orally administered medications.
• Hormonal birth control: Mounjaro may decrease the efficacy of oral hormonal contraceptives.
• Other GLP-1 medications: Including Ozempic, Saxenda, Victoza, Byetta, or Bydureon.
• Other products for weight loss: Including dietary supplements.

 

Most Serious Side Effects of Mounjaro

While rare, serious side effects can occur with Mounjaro. Monitor for:

• Thyroid C-Cell Tumors
• Severe Gastrointestinal Disease
• Acute Kidney Injury
• Acute Gallbladder Disease
• Inflammation of Pancreas (Acute Pancreatitis)
• Allergic Reactions
• Low Blood Sugar (Hypoglycemia)
• Diabetic Retinopathy Complications
• Suicidal Behavior and Ideation
• Pen-sharing poses a risk of infection.

Most Common Side Effects of Mounjaro

• Nausea
• Diarrhea
• Vomiting
• Constipation
• Stomach pain
• Indigestion
• Injection site reactions
• Fatigue
• Allergic reactions
• Belching
• Hair loss
• Gastroesophageal reflux disease (heartburn)

You are encouraged to report negative side effects of prescription products to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. This information is not comprehensive. Please see the full Prescribing Information for complete safety information.