Safety Information for Zepbound®

Zepbound® contains the active ingredient tirzepatide, which mimics two hormones that regulate feelings of fullness, appetite, and blood sugar called glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP).

Zepbound® is approved by the FDA for the following purposes:

• Weight management: Zepbound® is approved to help reduce excess body weight and maintain long-term weight reduction in combination with a reduced-calorie diet and increased physical activity for:
  • Adults and people aged 12 years and older with a BMI (body mass index) of 30 or higher.
  • Adults with a BMI of 27 or higher who have at least one weight-related condition.

Limitations of use:

• Zepbound® should not be used with other tirzepatide medications or GLP-1 receptor agonists.
• The safety of using Zepbound® with other weight loss products, including prescription drugs, over-the-counter medications, or herbal supplements, hasn’t been confirmed.
• Zepbound® hasn’t been studied in people with a history of pancreatitis.

Your doctor will not prescribe Zepbound® 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 Zepbound®.

Before starting Zepbound®, 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.
• Have or have had depression, suicidal thoughts, or other mental health concerns.
• Are pregnant or planning to become pregnant. Zepbound® 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 Zepbound® passes into breast milk.

Zepbound® 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 things to keep in mind when taking Zepbound®:

• Rotate the 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 dosing schedule and instructions given by your clinician, and consult them before making any changes.

If you take more Zepbound® 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 Zepbound® stays in the body for about five days, monitoring may be necessary for a short period.

Before you start Zepbound®, 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

Zepbound® 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, Mounjaro, 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.

Zepbound® 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 Zepbound® 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 that run in your family, such as:

• Type 1 diabetes: Zepbound® is not intended for the treatment of type 1 diabetes.
• Thyroid cancer: Zepbound® 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 Zepbound®.
• Allergies: Let your clinician know if you’re allergic to tirzepatide or any of the ingredients in Zepbound®
• Pancreas problems: Zepbound® is not recommended if you’ve had pancreatitis (inflammation of the pancreas).
• Gallbladder issues: Zepbound® 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 Zepbound® is suitable for you.
• Eye problems: Zepbound® can sometimes worsen diabetic retinopathy, so share any eye health concerns with your clinician.
• Depression: If you have a history of depression or suicidal thoughts, discuss this with your clinician before starting Zepbound®.

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 Zepbound® is safe for you.

Pregnancy and breastfeeding

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

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

If you become pregnant while taking Zepbound®, contact your doctor right away. There’s a registry to track pregnancy outcomes for those exposed to Zepbound® during pregnancy. You and your healthcare provider can report it by calling Eli Lilly at 1-800-LillyRx (1-800-545-5979).

For more information, check the Zepbound® prescribing information.

Your health is important to us. We want to ensure you’re informed about Zepbound®’s potential side effects. Below is an overview of possible side effects, starting with common ones and followed by more serious concerns.

Most common side effects

Many people experience mild side effects when starting Zepbound®, which usually decrease over time. Common side effects include:

• Nausea
• Diarrhea
• Vomiting
• Constipation
• Stomach pain

While there are no foods you must completely avoid with Zepbound®, 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 Zepbound®, use Noom’s GLP-1 Companion and a color-coded system to help you make better food choices.

Serious side effects and warnings

Zepbound® may cause serious side effects. If you notice any of the following symptoms, get immediate medical attention:

• Severe stomach issues: Some people using Zepbound® have reported severe stomach problems. Inform your healthcare provider immediately if you experience ongoing or severe stomach issues.
• Allergic reactions: Stop using Zepbound® 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 Zepbound®. Seek immediate medical attention for sudden vision changes.
• Low blood sugar (hypoglycemia): If you have diabetes and use Zepbound® 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: Zepbound® 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 Zepbound®.
• Depression or suicidal thoughts: Be aware of any changes in mood, behavior, or thoughts. Get immediate help if you notice new or worsening mental health symptoms.

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

• If you’re experiencing mild side effects, contact your healthcare provider or clinician for advice.
• If you believe you’re having a medical emergency, call 911 immediately.
• If you take more Zepbound® than prescribed, contact your healthcare provider or seek medical advice as soon as possible. You can also reach a Poison Center expert at 1-800-222-1222 for immediate guidance.
• For more information about Zepbound® or to report side effects, you can contact Eli Lilly at 1-800-LillyRx (1-800-545-5979) or visit www.zepbound.lilly.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 Zepbound prescribing information.