Safety Information for Mounjaro®

Mounjaro^® contains the active ingredient tirzepatide. Tirzepatide mimics two hormones in the body: glucagon-like peptide-1 (GLP-1) and a glucose-dependent insulinotropic polypeptide (GIP).

Mounjaro^® can be prescribed for the following purposes:

• Improving blood sugar control (FDA-approved use): Mounjaro^® is approved for use in adults with type 2 diabetes to help manage blood sugar levels.
• Weight loss (off-label): Mounjaro^® can be prescribed to support weight loss in adults with a BMI of 30 or higher, or 27 or higher with a weight-related health condition, by reducing appetite and promoting gradual weight reduction.

Limitations of use:

• Mounjaro^® hasn’t been studied in people with a history of pancreatitis.
• Mounjaro^® is not for people with type 1 diabetes.

Your doctor will not prescribe Mounjaro^® if:

• You or any of your family members have 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 had a serious allergic reaction to tirzepatide or any of the ingredients in Mounjaro^®.

Before starting Mounjaro^®, make sure to inform your healthcare provider if you:

• Have or have had issues with your pancreas or kidneys.
• Have type 2 diabetes with a history of diabetic retinopathy (eye problems).
• Are pregnant or planning to become pregnant. Mounjaro^® may harm your unborn baby, so you should stop using it at least two months before trying to conceive.
• Are breastfeeding or planning to breastfeed, as it’s unknown whether Mounjaro^® passes into breast milk.

Mounjaro^® is a once-weekly injection that should be taken on the same day each week. It can be administered at any time of day, with or without food. Your clinician will show you the proper technique and recommend the best injection sites, such as your abdomen, thigh, or upper arm. Here are some important things to remember about taking Mounjaro^®:

Rotate your injection site: Be sure to rotate your injection sites each week to prevent skin irritation.
Follow the dosing schedule: Your clinician will start you on the lowest dose and gradually increase it to minimize side effects. Always follow the schedule and instructions given by your clinician, and consult them before making any changes.

If you take more Mounjaro^® than prescribed, contact the Poison Help Line at 1-800-222-1222 or your doctor for advice. Your clinician will provide any needed treatment based on your symptoms. Because Mounjaro^® stays in the body for about five days, monitoring may be necessary for a short period.

Before you start Mounjaro^®, it’s important to share some key information with your clinician.

Medications and supplements

List all the medications and supplements you’re taking, including:

• Prescription drugs
• Over-the-counter medications
• Vitamins
• Herbal or dietary supplements

Mounjaro^® can interact with certain medications. Be sure to mention if you’re taking:

• Insulin (Lantus, Humalog, Novolog)
• May increase the risk of low blood sugar (hypoglycemia) in people with type 2 diabetes.
• Sulfonylureas (Glipizide, Glyburide, Glimepiride)
• May increase the risk of low blood sugar (hypoglycemia) in people with type 2 diabetes.
• Other GLP-1 medications (Trulicity^®, Ozempic^®, Wegovy^®, Saxenda^®, Zepbound^®, Victoza^®, Rybelsus^®)
• There have not been enough studies to determine the safety and efficacy of combining GLP-1s.
• Medications for cutaneous T-cell lymphoma (CTCL) (Bexarotene)
• May increase the probability of pancreatitis or inflammation of the pancreas.
• Medications that can affect blood glucose levels (Gatifloxacin)
• May cause severe levels of hypoglycemia (low blood sugar) that can result in death.

Mounjaro^® may also interact with other medications that aren’t listed here. Since it slows down how your stomach empties, it can affect how your body absorbs oral medications. Always check with your clinician before combining Mounjaro® with any medication or supplement. Your clinician will guide you on how to manage your treatments safely.

Medical history

Discuss any health conditions you have or those that run in your family, such as:

• Type 1 diabetes: Mounjaro^® is not intended for the treatment of type 1 diabetes.
• Thyroid cancer: Mounjaro^® comes with a boxed warning about the increased risk of medullary thyroid carcinoma (MTC). It should not be used by anyone with a personal or family history of MTC or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Be aware of symptoms like a lump in the neck, difficulty swallowing, or persistent hoarseness, and talk to your doctor if you notice any of these. Regular thyroid checks may not reliably detect MTC early in people using Mounjaro^®.
• Allergies: Let your clinician know if you’re allergic to tirzepatide or any of the ingredients in Mounjaro^®.
• Pancreas problems: Mounjaro^® is not recommended if you’ve had pancreatitis (inflammation of the pancreas).
• Gallbladder issues: Mounjaro^® can worsen gallbladder disease, so inform your clinician if you’ve had any related problems.
• Kidney or liver problems: If you’ve had kidney or liver issues, your clinician will determine if Mounjaro^® is suitable for you.
• Eye problems: Mounjaro^® can sometimes worsen diabetic retinopathy, so share any eye health concerns with your clinician.

Always provide accurate and complete information about your health. Not sharing important details can lead to serious risks and complications. This helps your clinician ensure Mounjaro^® is safe for you.

Pregnancy and breastfeeding

If you’re pregnant, planning to become pregnant, or breastfeeding, let your clinician know.

You cannot use Mounjaro^® during pregnancy because it may pose risks to the baby. Women planning to become pregnant should stop using Mounjaro^® at least two months before trying to conceive.
If you’re breastfeeding, inform your clinician. It’s unknown if Mounjaro^® passes into breast milk, so avoiding using it while breastfeeding is recommended.

If you become pregnant while taking Mounjaro^®, contact your doctor right away. There’s a registry to track pregnancy outcomes for those exposed to Mounjaro^® during pregnancy. You and your healthcare provider can report it by calling Eli Lilly at 1-833-807-MJRO (833-807-6576).

For more information, check the Mounjaro^® prescribing information.

Your health is important to us. We want to ensure you’re informed about the potential side effects of Mounjaro^®. Below is an overview of potential side effects, starting with the most common, followed by more serious concerns.

Most common side effects

Many people experience mild side effects when starting Mounjaro^®; these usually decrease over time. They include:

• Nausea
• Diarrhea
• Vomiting
• Constipation
• Stomach pain

While there are no foods you must completely avoid with Mounjaro^®, some may impact its effectiveness or worsen side effects. Limiting sugary drinks, fried foods, and gas-forming vegetables can help reduce common side effects.

For more guidance on managing your diet with Mounjaro^®, use Noom’s GLP-1 Companion.  Our color-coded food system can also help you make better food choices.

Serious side effects and warnings

Mounjaro® may cause serious side effects and worsen some conditions. If you notice any of the following symptoms, get immediate medical attention:

• Severe stomach issues: Some people using Mounjaro^® have reported severe stomach problems. If you experience ongoing or severe stomach issues, inform your healthcare provider immediately.
• Allergic reactions: Stop using Mounjaro^® and seek immediate medical help if you experience swelling of the face, lips, tongue, or throat, trouble breathing or swallowing, severe rash or itching, fainting, dizziness, or a rapid heartbeat.
• Pancreatitis: Look for severe, persistent stomach pain that may radiate to your back, with or without vomiting.
• Vision changes: Inform your clinician if you notice changes in your vision while using Mounjaro^®. Seek immediate medical attention for sudden vision changes.
• Low blood sugar (hypoglycemia): If you have diabetes and use Mounjaro^® with other blood sugar-lowering medications, like insulin or sulfonylureas, you may experience low blood sugar. Symptoms include dizziness, blurred vision, anxiety, sweating, confusion, shakiness, and a fast heartbeat.
• Kidney problems: Mounjaro^® may worsen kidney issues, especially if you have diarrhea, nausea, or vomiting, which can lead to dehydration. Watch for symptoms like swelling in your legs or ankles, fatigue, shortness of breath, or changes in urination.
• Thyroid tumors: Monitor for a lump or swelling in your neck, hoarseness, difficulty swallowing, or shortness of breath. An increased risk of thyroid tumors has been seen in animal studies with Mounjaro^®.

For full details on all potential side effects, visit the Mounjaro^® website or talk to your clinician.

• If you’re experiencing mild side effects, contact your healthcare provider or clinician for advice.
• If you think you’re having a medical emergency, call 911 immediately.
• If you take more Mounjaro^® than prescribed, contact your healthcare provider or seek medical advice immediately. You can also reach a Poison Center expert right away at 1-800-222-1222.
• For more information about Mounjaro^® or to report side effects, you can contact Eli Lilly at 1-833-807-MJRO (833-807-6576) or visit www.mounjaro.com.
• You can also report side effects directly to the FDA at www.fda.gov/medwatch or by calling 1-800-FDA-1088.

For complete safety information, please refer to the Mounjaro^® prescribing information.