Tirzepatide Safety Card

INDICATION

Tirzepatide 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.

  • Tirzepatide 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 when taken with other prescription, over-the-counter, or herbal weight loss products. It is not known if Tirzepatide can be used in people who have had pancreatitis. It is not known if Tirzepatide is safe and effective for use in children under 18 years of age.

SAFETY SUMMARY WITH WARNINGS

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

Tirzepatide may cause serious side effects, including:

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 use Tirzepatide. 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 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, 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 Tirzepatide 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 Tirzepatide.

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 Tirzepatide 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 Tirzepatide. 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 www.fda.gov/medwatch.

Before using Tirzepatide

  • Your healthcare provider should show you how to use Tirzepatide 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 Tirzepatide. Birth control pills may not work as well while using Tirzepatide. 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.

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? Tirzepatide may harm your unborn baby. Tell your healthcare provider if you become pregnant while using Tirzepatide. It is not known if Tirzepatide passes into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using Tirzepatide.

  • Pregnancy Exposure Registry: There will be a pregnancy exposure registry for women who have taken Tirzepatide during pregnancy. The purpose of this registry is to collect information about the health of you and your baby.

How to take

  • Read the Instructions for Use that come with Tirzepatide.
  • Use Tirzepatide exactly as your healthcare provider says.
  • Tirzepatide is injected under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm.
  • Use Tirzepatide 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 Tirzepatide, call your healthcare provider, seek medical advice promptly, or contact a Poison Center expert right away at 1-800-222-1222.

Learn more

Tirzepatide is a prescription medicine. 

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