Read this Medication Guide before you start using TIRZEPATIDE and each time you get a refill. There may be new information. This
information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
 

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

• Possible thyroid tumors, including cancer. Tell your healthcare 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 rats, TIRZEPATIDE and medicines that work like TIRZEPATIDE caused thyroid tumors, including thyroid cancer. It is not known if TIRZEPATIDE will cause thyroid tumors, or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.

• Do not use TIRZEPATIDE if you or any of your family have ever had a type of  thyroid cancer called MTC, or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

 

What is TIRZEPATIDE?

TIRZEPATIDE is an injectable prescription medicine that may help adults with:

• obesity, or some adults with overweight who also have weight-related medical problems, to lose excess body weight and keep the weight off.

• moderate to severe obstructive sleep apnea (OSA) and obesity to improve their OSA.

 

​TIRZEPATIDE should be used with a reduced-calorie diet and increased physical activity.

TIRZEPATIDE contains tirzepatide and should not be used with other tirzepatide-containing products or any GLP-1 receptor agonist medicines.

It is not known if TIRZEPATIDE is safe and effective for use in children.​

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Do not use TIRZEPATIDE if:

• you or any of your family have ever had a type of thyroid cancer called MTC or if you have an endocrine system condition called MEN 2.

• you have had a serious allergic reaction to tirzepatide or any of the ingredients in TIRZEPATIDE. See the end of this Medication Guide for a complete list of ingredients in TIRZEPATIDE.

 

​​Before using TIRZEPATIDE, tell your healthcare provider about all of your medical conditions, including if you:

• have or have had problems with your pancreas or kidneys.

• have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food.

• have a history of diabetic retinopathy.

• are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation).

• are pregnant or plan to become pregnant, TIRZEPATIDE may harm your unborn baby. Tell your healthcare provider if you become pregnant while using TIRZEPATIDE. Birth control pills by mouth may not work as well while using TIRZEPATIDE. If you take birth control pills by mouth, your healthcare provider may recommend another type of birth control for 4 weeks after you start TIRZEPATIDE and for 4 weeks after each increase in your dose of TIRZEPATIDE. Talk to your healthcare provider about birth control methods that may be right for you while using TIRZEPATIDE.

• are breastfeeding or plan to breastfeed. It is not known if TIRZEPATIDE passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while using TIRZEPATIDE.

 

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. TIRZEPATIDE may affect the way some medicines work, and some medicines may affect the way TIRZEPATIDE works. Before using TIRZEPATIDE, 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.

 

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take TIRZEPATIDE?

• Read the Instructions for Use that comes with TIRZEPATIDE.

• Use TIRZEPATIDE exactly as your healthcare provider tells you to. A healthcare provider should show you how to prepare to inject your dose of TIRZEPATIDE before injecting the first time.

• Use TIRZEPATIDE with a reduced-calorie diet and increased physical activity.

• TIRZEPATIDE is injected under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm. See detailed instructions here.

• Use TIRZEPATIDE 1 time each week, at any time of the day.

• You may change the day of the week you use TIRZEPATIDE as long as the time between the 2 doses is at least 3 days (72 hours).

• If you miss a dose of TIRZEPATIDE, take the missed dose as soon as possible within 4 days (96 hours) after the missed dose. If more than 4 days have passed, skip the missed dose and take your next dose on the regularly scheduled day. Do not take 2 doses of TIRZEPATIDE within 3 days (72 hours) of each other.

• TIRZEPATIDE may be taken with or without food.

• Change (rotate) your injection site with each weekly injection. You may use the same area of your body but be sure to choose a different injection site in that area. Do not use the same site for each injection.

• In case of overdose, get medical help or contact a Poison Center expert right away at 1-800-222-1222. Advice is also available online at poisonhelp.org.

 

What are the possible side effects of TIRZEPATIDE?

TIRZEPATIDE may cause serious side effects, including:

• See "What is the most important information I should know about TIRZEPATIDE?"

• severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use TIRZEPATIDE. 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 take TIRZEPATIDE. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include:

  • pain in your upper stomach (abdomen)

  • yellowing of skin or eyes (jaundice)

  • fever

  • clay-colored stools

• inflammation of your pancreas (pancreatitis). Stop using TIRZEPATIDE 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 TIRZEPATIDE 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

  • fainting or feeling dizzy

  • problems breathing or swallowing

  • very rapid heartbeat

  • severe rash or itching

• low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use TIRZEPATIDE with medicines that can cause low blood sugar, such as an insulin or sulfonylurea. Signs and symptoms of low blood sugar may include:

  • ​dizziness or light-headedness

  • blurred vision anxiety, irritability, or mood changes

  • sweating

  • slurred speech

  • hunger

  • confusion

  • drowsiness

  • shakiness

  • weakness

  • headache

  • fast heartbeat

  • feeling jittery

  • changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with TIRZEPATIDE.

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

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

The most common side effects of TIRZEPATIDE include:

• nausea

• stomach (abdominal) pain

• allergic reactions

• diarrhea

• indigestion

• belching

• vomiting

• injection site reactions

• hair loss

• constipation

• feeling tired

• heartburn

Talk to your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of TIRZEPATIDE. Call your doctor for medical advice about side effects.

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How should I store TIRZEPATIDE?

Store TIRZEPATIDE in the refrigerator between 36°F to 46°F (2°C to 8°C). Store TIRZEPATIDE in the original carton until use to protect it from light.

 

Keep TIRZEPATIDE and all medicines out of the reach of children.

General information about the safe and effective use of TIRZEPATIDE.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use TIRZEPATIDE for a condition for which it was not prescribed. Do not give TIRZEPATIDE to other people, even if they have the same condition you have. It may harm them. You can ask your pharmacist or healthcare provider for information about TIRZEPATIDE that is written for health professionals.

What are the ingredients in TIRZEPATIDE?

Active ingredient: tirzepatide

Inactive ingredients: benzyl alcohol, sodium chloride, sodium phosphate dibasic, and sterile water for injection