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SAFETY SUMMARY WITH WARNINGS
Warnings – Zepbound® may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.

• Do not use Zepbound® if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).
• Do not use Zepbound® if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• Do not use Zepbound® if you have had a serious allergic reaction to tirzepatide or any of the ingredients in Zepbound®.

Zepbound® may cause serious side effects, including: Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Zepbound®. Tell your healthcare provider if you have stomach problems that are severe or will not go away.

Kidney problems (kidney failure). Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration.

Gallbladder problems. Gallbladder problems have happened in some people who use Zepbound®. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools.

Inflammation of the pancreas (pancreatitis). Stop using Zepbound® and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.

Serious allergic reactions. Stop using Zepbound® and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat.

Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Zepbound® with medicines that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness or feeling jittery.

Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Zepbound®.

Depression or thoughts of suicide. You should pay attention to changes in your mood, behaviors, feelings or thoughts. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you.

Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Zepbound® may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking Zepbound® before you are scheduled to have surgery or other procedures.

Common Side Effects
The most common side effects of Zepbound® include nausea, diarrhea, vomiting, constipation, stomach (abdominal) pain, indigestion, injection site reactions, feeling tired, allergic reactions, belching, hair loss, and heartburn. These are not all the possible side effects of Zepbound®. Talk to your healthcare provider about any side effect that bothers you or doesn’t go away.

Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before using Zepbound
Your healthcare provider should show you how to use Zepbound® before you use it for the first time.
Tell your healthcare provider if you are taking medicines to treat diabetes including an insulin or sulfonylurea which could increase your risk of low blood sugar. Talk to your healthcare provider about low blood sugar levels and how to manage them.

If you take birth control pills by mouth, talk to your healthcare provider before you use Zepbound®. Birth control pills may not work as well while using Zepbound®. Your healthcare provider may recommend another type of birth control for 4 weeks after you start Zepbound® and for 4 weeks after each increase in your dose of Zepbound®.
Review these questions with your healthcare provider:

• Do you have other medical conditions, including problems with your pancreas or kidneys, or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food?
• Do you take diabetes medicines, such as insulin or sulfonylureas?
• Do you have a history of diabetic retinopathy?
• Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)?
• Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements?

Are you pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed? Zepbound® may harm your unborn baby. Tell your healthcare provider if you become pregnant while using Zepbound®. It is not known if Zepbound® passes into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using Zepbound®.

Pregnancy Exposure Registry: There will be a pregnancy exposure registry for women who have taken Zepbound® during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may contact Lilly at 1-800-LillyRx (1-800-545-5979).

How to Take
Read the Instructions for Use that come with Zepbound®.
Use Zepbound® exactly as your healthcare provider says.
Use Zepbound® with a reduced-calorie diet and increased physical activity.
Zepbound® is injected under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm.
Use Zepbound® 1 time each week, at any time of the day.
Change (rotate) your injection site with each weekly injection. Do not use the same site for each injection.
If you take too much Zepbound®, call your healthcare provider, seek medical advice promptly, or contact a Poison Center expert right away at 1-800-222-1222.
Zepbound® injection is approved as a 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg per 0.5 mL in single-dose pen or single-dose vial.
Zepbound® is a prescription medicine. For more information, call 1-800-LillyRx (1-800-545-5979).

This summary provides basic information about Zepbound® but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Zepbound® and how to take it. Your healthcare provider is the best person to help you decide if Zepbound® is right for you.

Do not share your Ozempic® pen with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.

What is the most important information I should know about Ozempic®?
Ozempic® may cause serious side effects, including:

Possible thyroid tumors, including cancer. Tell your health care provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, Ozempic® and medicines that work like Ozempic® caused thyroid tumors, including thyroid cancer. It is not known if Ozempic® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.

Do not use Ozempic® if you or any of your family have ever had MTC, or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)

Do not use Ozempic® if:
you or any of your family have ever had MTC or if you have MEN 2
you are allergic to semaglutide or any of the ingredients in Ozempic®. See symptoms of serious allergic reaction in “What are the possible side effects of Ozempic®?”

• Before using Ozempic®, tell your health care provider if you have any other medical conditions, including if you:
• Have or have had problems with your pancreas
• Have a history of diabetic retinopathy
• Have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food
• Are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)
• Are pregnant or breastfeeding or plan to become pregnant or breastfeed. It is not known if Ozempic® will harm your unborn baby or pass into your breast milk. You should stop using Ozempic® at least 2 months before you plan to become pregnant.

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and other medicines to treat diabetes, including insulin or sulfonylureas.

What are the possible side effects of Ozempic®?
Ozempic® may cause serious side effects, including: inflammation of your pancreas (pancreatitis). Stop using Ozempic® and call your health care provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back
changes in vision. Tell your health care provider if you have changes in vision during treatment with Ozempic® low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Ozempic® with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include: dizziness or lightheadedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, and feeling jittery
dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your health care provider right away if you have nausea, vomiting, or diarrhea that does not go away
severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Ozempic®. Tell your health care provider if you have stomach problems that are severe or will not go away
serious allergic reactions. Stop using Ozempic® and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or very rapid heartbeat gallbladder problems. Gallbladder problems have happened in some people who take Ozempic®. Tell your health care provider right away if you get symptoms which may include: pain in your upper stomach (abdomen), fever, yellowing of the skin or eyes (jaundice), or clay-colored stools food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Ozempic® may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your health care providers that you are taking Ozempic® before you are scheduled to have surgery or other procedures.

The most common side effects of Ozempic® may include nausea, vomiting, diarrhea, stomach (abdominal) pain, and constipation.