Efforts to Improve Our Type 2 Diabetes and Obesity Medicines Supply

Mounjaro may cause serious side effects, including:

Inflammation of the pancreas (pancreatitis). Stop using Mounjaro 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.

Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Mounjaro 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 light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, or mood changes, hunger, weakness and feeling jittery.

Serious allergic reactions. Stop using Mounjaro 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, and very rapid heartbeat.

Kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration.

Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Mounjaro. Tell your healthcare provider if you have stomach problems that are severe or will not go away.

Changes in vision. Tell your healthcare provider if you have changes in vision during treatment with Mounjaro.

Gallbladder problems. Gallbladder problems have happened in some people who use Mounjaro. 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), and clay-colored stools.

Common side effects:

The most common side effects of Mounjaro include nausea, diarrhea, decreased appetite, vomiting, constipation, indigestion, and stomach (abdominal) pain. These are not all the possible side effects of Mounjaro. Talk to your healthcare provider about any side effect that bothers you or doesn't go away.

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

Before using Mounjaro:

• Your healthcare provider should show you how to use Mounjaro before you use it for the first time.
• Talk to your healthcare provider about low blood sugar and how to manage it.
• If you take birth control pills by mouth, talk to your healthcare provider before you use Mounjaro. Birth control pills may not work as well while using Mounjaro. Your healthcare provider may recommend another type of birth control for 4 weeks after you start Mounjaro and for 4 weeks after each increase in your dose of Mounjaro.

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 other diabetes medicines, such as insulin or sulfonylureas?

❑Do you have a history of diabetic retinopathy?

❑Are you pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed? It is not known if Mounjaro will harm your unborn baby or pass into your breast milk.

❑Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements?

How to take:

• Read the Instructions for Use that come with Mounjaro.
• Use Mounjaro exactly as your healthcare provider says.
• Mounjaro is injected under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm.
• Use Mounjaro 1 time each week, at any time of the day.
• Do not mix insulin and Mounjaro together in the same injection.
• You may give an injection of Mounjaro and insulin in the same body area (such as your stomach area), but not right next to each other.
• Change (rotate) your injection site with each weekly injection. Do not use the same site for each injection.
• If you take too much Mounjaro, call your healthcare provider or seek medical advice promptly.

Learn more:

Mounjaro is a prescription medicine. For more information, call 1-833-807-MJRO (833-807-6576) or go to www.mounjaro.lilly.com.

This summary provides basic information about Mounjaro 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 Mounjaro and how to take it. Your healthcare provider is the best person to help you decide if Mounjaro is right for you.

TR CON CBS 14SEP2022

TRULICITY (DULAGLUTIDE) INDICATIONS AND SAFETY SUMMARY WITH WARNINGS

Trulicity (Trῡ-li-si-tee) is for adults and children 10 years of age and older with type 2 diabetes used along with diet and exercise to improve blood sugar (glucose). Trulicity is also used in adults with type 2 diabetes to reduce the risk of major cardiovascular events (problems having to do with the heart and blood vessels) such as death, heart attack, or stroke in people who have heart disease or multiple cardiovascular risk factors.

• It is not known if TRULICITY can be used in people who have had inflammation of the pancreas (pancreatitis). TRULICITY is not for use in people with type 1 diabetes and is not recommended for use in people with severe stomach or intestinal problems. It is not known if TRULICITY is safe and effective in children under 10 years of age.
• Trulicity is given through an injection (needle). You take it once a week by injecting it under the skin of your stomach, thigh, or upper arm.

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

• Do not use Trulicity if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).
• Do not use Trulicity if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• Do not use Trulicity if you are allergic to dulaglutide or other ingredients in Trulicity.

Ask your healthcare provider how to recognize the serious side effects below and what to do if you think you have one:

Inflamed pancreas (pancreatitis). Stop using Trulicity and call your healthcare provider right away if you have severe pain in your stomach area (abdomen), with or without vomiting, that will not go away. You may feel the pain from your abdomen to your back.
Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use TRULICITY 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 light-headedness, confusion or drowsiness, headache, blurred vision, slurred speech, fast heartbeat, sweating, hunger, shakiness, feeling jittery, weakness, anxiety, irritability, or mood changes.
Serious allergic reactions. Stop using Trulicity and get medical help right away if you have any symptoms of a serious allergic reaction which may include swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting, or feeling dizzy, or very rapid heartbeat.
Acute kidney injury. In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration). This may cause kidney problems to get worse.
Severe stomach problems. Trulicity may cause stomach problems, which could be severe.
Changes in vision. Tell your healthcare provider if you have changes in your eyesight (vision) during treatment with Trulicity.
Gallbladder problems. Gallbladder problems have happened in some people who take Trulicity. 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), clay-colored stools.

Common side effects:

The most common side effects of Trulicity include nausea, diarrhea, vomiting, abdominal pain and decreased appetite, indigestion, and fatigue.

These are not all the possible side effects of Trulicity

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

Before using:

• Your healthcare provider should show you how to use Trulicity before you use it for the first time.
• Before you use Trulicity, talk to your healthcare provider about low blood sugar and how to manage it.

Review these questions with your healthcare provider:

❑Do you have other medical conditions, including problems with your pancreas, kidneys, liver, or stomach, or have a history of diabetic retinopathy (vision problems related to diabetes)?

❑Do you take other diabetes medicines, such as insulin or sulfonylureas?

❑Are you pregnant or plan to become pregnant or breastfeeding or plan to breastfeed?

❑Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements?

How to take:

• Read the Instructions for Use that come with Trulicity.
• Use Trulicity exactly as your healthcare provider says.
• Do not share your Trulicity pen, syringe, or needles with another person.
• Do not give Trulicity to other people.
• If you take too much Trulicity, call your healthcare provider or seek medical advice promptly.

Learn more:

Trulicity is a prescription medicine. For more information, call 1-844-TRU-INFO (1-844-878-4636) or go to www.trulicity.lilly.com.

This summary provides basic information about Trulicity 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 Trulicity and how to take it. Your healthcare provider is the best person to help you decide if Trulicity is right for you.

DG CON HL BS 17NOV2022

ZEPBOUND (TIRZEPATIDE) INDICATION AND SAFETY SUMMARY WITH WARNINGS

Zepbound (ZEHP-bownd) is an injectable prescription medicine that may help adults with obesity, or with excess weight (overweight) who also have weight-related medical problems, lose weight and keep it off. It should be used with a reduced-calorie diet and increased physical activity.

• Zepbound contains tirzepatide and should not be used with other tirzepatide-containing products or any GLP-1 receptor agonist medicines. It is not known if Zepbound is safe and effective when taken with other prescription, over-the-counter, or herbal weight loss products. It is not known if Zepbound can be used in people who have had pancreatitis. It is not known if Zepbound is safe and effective for use in children under 18 years of age.

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.

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 healthcare provider 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 insulin or sulfonylureas 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?

❑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.
• 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.

Learn more:

Zepbound is a prescription medicine. For more information, call 1-800-LillyRx (1-800-545-5979) or go to www.zepbound.lilly.com.

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.

ZP CON CBS 08NOV2023