Important Safety Information for Mounjaro® (tirzepatide) injections

What is Mounjaro® prescribed for?

Mounjaro® (tirzepatide) is a GIP (glucose-dependent insulinotropic polypeptide) / GLP-1 (glucagon-like peptide-1) receptor agonist, a medication that helps the body improve insulin response and improve blood sugar levels.

You may be prescribed Mounjaro® for:

• To improve blood sugar control: Mounjaro® is approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. (FDA-approved)
• To support chronic weight management (off-label):In appropriate adults with obesity or who are overweight with weight-related conditions, your clinician may prescribe Mounjaro® off-label to support medically supervised weight reduction.

Important considerations

• Mounjaro® is not for people with type 1 diabetes.
• Mounjaro® has been associated with pancreatitis and severe gastrointestinal side effects in some patients.
• Dosing, titration, and ongoing monitoring should always be determined by a licensed healthcare provider.

Who should not use Mounjaro®?

Do not use Mounjaro® if:

• You have a personal or family history of medullary thyroid carcinoma (MTC).
• You have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• You have had a serious hypersensitivity reaction (such as anaphylaxis or angioedema) to tirzepatide or any ingredient in Mounjaro®.

How do I take Mounjaro®?

Mounjaro® is given as a subcutaneous (under the skin) injection once weekly.

• It can be injected into the abdomen, thigh, or upper arm.
• Use it on the same day each week, at any time of day, with or without food.
• Rotate injection sites each week to reduce irritation.

Never stop, restart, or change your dose without guidance from your NavioMD provider..

Before starting Mounjaro®, tell your provider if:

Your provider needs a complete picture of your health and medications to determine if Mounjaro® is appropriate and safe for you.

Medical history

Tell your clinician if you:

• Have type 1 diabetes (Mounjaro® is not approved for this use).
• Have a personal or family history of thyroid tumors, especially MTC, or MEN 2.
• Have ever had pancreatitis (inflammation of the pancreas).
• Have kidney problems, including a history of acute kidney injury or chronic kidney disease.
• Have liver disease.
• Have a history of gallbladder disease (gallstones, cholecystitis).
• Have diabetic retinopathy or other significant eye disease.
• Have severe gastrointestinal conditions, such as severe gastroparesis or significant problems with stomach emptying.
• Have any history of frequent or severe hypoglycemia.
• Have a history of severe allergic reactions to injectable medications.
• Have depression, anxiety, or other mood disorders, or a history of suicidal thoughts or behaviors.
• Are scheduled for surgery or any procedure requiring general anesthesia or deep sedation.
• Are pregnant, planning to become pregnant, or breastfeeding.

Medications and supplements

Provide a full list of everything you take, including:

• Prescription medications
• Over-the-counter medicines
• Vitamins and minerals
• Herbal products and supplements

Be sure to mention if you are taking:

• Insulin or sulfonylureas (such as glipizide, glyburide, glimepiride)
  • These can increase the risk of low blood sugar when combined with Mounjaro®. Your clinician may need to reduce doses of these medications.
• Other GLP-1 receptor agonists (e.g., semaglutide, liraglutide, dulaglutide, etc.)
  • Combining these with Mounjaro® (tirzepatide) is not recommended.
• Oral medications with a narrow therapeutic index (for example, warfarin), or medicines where timing and absorption are critical.
• Oral hormonal contraceptives (birth control pills)

Pregnancy and breastfeeding

• If you are pregnant, planning to become pregnant or breastfeeding.

Common side effects

Some people experience side effects early in treatment or during dose increases. These are often mild to moderate and tend to decrease over time.

Common side effects may include:

• Nausea
• Diarrhea
• Decreased appetite
• Vomiting
• Constipation
• Indigestion (heartburn, upset stomach)
• Stomach (abdominal) pain or discomfort

If you continue to experience side effects, please contact your NavioMD provider by starting an Urgent Care Visit through your patient portal.

Serious side effects and warnings

Mounjaro® can cause serious side effects. Some may require urgent medical evaluation or stopping the medication.If you experience any of the following, seek medical care and contact your healthcare provider:

Risk of thyroid C-cell tumors

• In studies with rats, medicines like tirzepatide have been shown to cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC).
• It is not known whether Mounjaro® causes thyroid tumors or MTC in humans, but out of caution, it must not be used in people with a personal or family history of MTC or MEN 2.
• Call your clinician right away if you notice:
  • A lump or swelling in your neck
  • Persistent hoarseness
  • Difficulty swallowing
  • Trouble breathing

Pancreatitis (inflammation of the pancreas)

• Mounjaro® and similar medications have been associated with acute pancreatitis, including severe cases.
• Stop Mounjaro® and seek care if you develop:
  • Severe, persistent abdominal pain (with or without vomiting) that may radiate to your back.

Your clinician will evaluate you and determine if it is safe to continue.

Low blood sugar (hypoglycemia)

Watch for:

• Shakiness, sweating
• Dizziness or lightheadedness
• Headache, blurred vision
• Confusion, irritability, or feeling “out of it”
• Rapid heartbeat, feeling jittery
• Extreme hunger or weakness

Severe gastrointestinal (GI) reactions

• Mounjaro® can cause intense nausea, vomiting, or diarrhea, which may lead to dehydration and, in some cases, kidney problems or hospital care.
• It is not recommended in people with severe gastroparesis (very slow stomach emptying).
• Contact your clinician if you experience:
  • Ongoing, severe nausea or vomiting
  • Persistent abdominal pain or bloating
  • Inability to keep fluids down

Seek urgent care if you feel weak, dizzy, or unable to stay hydrated.

Kidney problems (acute kidney injury)

• Significant vomiting or diarrhea can lead to dehydration, which may worsen kidney function or cause acute kidney injury.
• Call your provider if you notice:
  • Swelling in your legs, ankles, or feet
  • Reduced urination or dark urine
  • New or worsening fatigue or shortness of breath

Gallbladder problems

Mounjaro® has been associated with gallbladder disease, including gallstones.

Watch for:

• Pain in the upper right or middle part of your abdomen
• Fever or chills
• Yellowing of the skin or eyes (jaundice)
• Pale or clay-colored stools

Serious allergic reactions (hypersensitivity)

Stop Mounjaro® and seek emergency care if you experience:

• Swelling of the face, lips, tongue, or throat
• Trouble breathing or swallowing
• Severe rash, hives, or itching
• Fainting, dizziness, or very fast heartbeat

Do not use Mounjaro® again if you have had a serious allergic reaction to tirzepatide.

Diabetic eye disease (diabetic retinopathy) changes

• Rapid improvements in blood sugar can temporarily worsen diabetic retinopathy in some people.
• Tell your clinician promptly if you notice:
  • Blurred vision
  • Sudden changes in eyesight
  • New floaters, dark spots, or visual disturbances

Pulmonary aspiration during surgery or deep sedation

Because Mounjaro® slows stomach emptying, food or liquid may remain in the stomach longer, which can increase the risk of stomach contents entering the lungs during general anesthesia or deep sedation.

• Tell your healthcare provider and anesthesiologist that you are taking Mounjaro® before any planned surgery or procedure.
• Your surgical team may adjust pre-procedure fasting instructions or discuss whether to temporarily hold the medication.

Mood changes or suicidal thoughts

Although not common, changes in mood or mental health are important to recognize.

Contact your clinician right away if you experience:

• New or worsening depression or anxiety
• Irritability, restlessness, or unusual behavior changes
• Thoughts of harming yourself or others

If you are experiencing a medical emergency, call 911 or go to the nearest emergency department immediately.

Reporting side effects

If you experience side effects:

• For mild or manageable symptoms, contact your NavioMD clinician through your patient portal for personalized guidance.
• For severe, worrisome, or rapidly worsening symptoms, seek urgent medical care or call 911.

You can also report side effects directly:

• Eli Lilly and Company (Mounjaro® manufacturer):Visit the contact resources provided with your medication packaging or on the official Mounjaro® website.
• FDA MedWatch:
  • Website: www.fda.gov/medwatch
  • Phone: 1-800-FDA-1088 (1-800-332-1088)

Reporting side effects contributes to ongoing safety monitoring of prescription medications.

Disclaimer

This information is provided for educational purposes only and does not replace medical advice from a licensed healthcare professional.

• Always speak with your NavioMD clinician or your own healthcare provider about your specific medical conditions, treatment options, and any questions you have about Mounjaro®.
• Do not start, stop, or change any medication without professional guidance.

For complete safety and prescribing details, please review the official Mounjaro® Safety Information and Medication Guide approved by the U.S. Food and Drug Administration (FDA).

References

• Mounjaro® (tirzepatide) Safety Information – Eli Lilly and Company

FDA Medication Guide – Mounjaro® (tirzepatide)