Patient Education

• Generic Name: tirzepatide

• Pronounced: tir ZEP a tide

• Brand Names: Mounjaro, Zepbound

What is the most important information I should know about tirzepatide?

Call your doctor at once if you have signs of a thyroid tumor, such as swelling or a lump in your neck, trouble swallowing, a hoarse voice, or shortness of breath.

You should not use this medicine if you or anyone in your family have or have ever had thyroid cancer or a condition called multiple endocrine neoplasia syndrome.

What is tirzepatide?

Mounjaro is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

This medicine is not for treating type 1 diabetes.

Zepbound is used with diet and exercise to manage weight in overweight or obese adults who also have at least one weight-related medical condition such as type 2 diabetes, high blood pressure, high cholesterol, obstructive sleep apnea, or heart problems.

Tirzepatide may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using tirzepatide?

You should not use tirzepatide if you are allergic to it, or if you have:

• a personal or family history of medullary thyroid carcinoma (a type of thyroid cancer); or

• multiple endocrine neoplasia type 2 (tumors in your glands).

Tell your doctor if you have or have ever had:

• pancreas problems;

• a severe stomach problem such as problems with digesting food or slowed emptying of your stomach (gastroparesis);

• diabetic retinopathy (a diabetes complication that affects the eyes); or

• kidney disease.

May harm an unborn baby. Do not use if you are pregnant. Tell your doctor if you become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of tirzepatide on the baby.

Tirzepatide can make birth control pills less effective. Ask your doctor about other birth control options such as an injection, implant, skin patch, vaginal ring, condom, diaphragm, cervical cap, or contraceptive sponge. If you take birth control pills you may need to use different birth control options for 4 weeks after starting this medicine and for 4 weeks each time the dose is raised.

Ask a doctor if it is safe to breastfeed while using this medicine.

How should I use tirzepatide?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Tirzepatide is injected under the skin once per week. If you change your dosing day, allow at least 3 days (72 hours) to pass between doses.

You may use tirzepatide with or without food. Drink plenty of liquids while you are using this medicine.

Your healthcare provider will show you where to inject tirzepatide. Do not inject into the same place two times in a row.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

You may give an injection of tirzepatide and insulin in the same area (such as upper arm), but not right next to each other.

Do not mix insulin and tirzepatide in the same injection.

Do not share this medicine with another person, even if they have the same symptoms you have.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Each injection pen or prefilled syringe is for one use only. Throw away after one use, even if there is still medicine left inside. Use a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Follow all storage instructions provided with tirzepatide. Your pharmacist can provide more information about how to store this medicine.

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if you are more than 4 days (96 hours) late for the dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using tirzepatide?

Never share an injection pen or prefilled syringe with another person, even if the needle has been changed. Sharing these devices can allow infections or disease to pass from one person to another.

What are the possible side effects of tirzepatide?

Stop using tirzepatide and get emergency medical help if you have:

• signs of an allergic reaction: hives; difficult breathing; feeling light-headed; swelling of your face, lips, tongue, or throat; or

• pancreatitis--severe pain in your upper stomach spreading to your back, nausea and vomiting.

Some people have thoughts about suicide while using tirzepatide. Tell your doctor right away if you have any sudden changes in mood or behavior, or thoughts about suicide.

Call your doctor at once if you have:

• severe stomach problems;

• changes in your vision;

• signs of a thyroid tumor--swelling or a lump in your neck, trouble swallowing, a hoarse voice, or if you feel short of breath;

• gallbladder problem--chalky-colored stools, stomach pain after eating, nausea, heartburn, bloating, and severe upper stomach pain that may spread to your back;

• low blood sugar--headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery; or

• kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath.

Common side effects may include:

• hair loss;

• tiredness;

• signs of an allergic reaction;

• bruising, swelling, warmth, redness, oozing, or bleeding where an injection was given;

• nausea, diarrhea, decreased appetite, vomiting; or

• heartburn, burping, constipation, indigestion, or stomach pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect tirzepatide?

Tirzepatide can slow your digestion, and it may take longer for your body to absorb any medicines you take by mouth.

Tell your doctor about all your other medicines, especially:

• insulin or oral diabetes medicine.

This list is not complete. Other drugs may affect tirzepatide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your doctor or pharmacist can provide more information about tirzepatide.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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

Please consult the pharmaceutical packaging for a full list of side effects, warnings, interactions, and additional information.

Note: The above statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

One size doesn’t fit all and every patient is unique. Drug compounding is the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of a patient by a pharmacist as the result of a practitioner’s prescription drug order. While compounded medications are not FDA-approved, they serve an important patient need—especially when FDA-approved medication is not available for treatment. The specific ingredients in your compounded formula will depend on your specific concerns and goals. It should be understood that your personal healthcare practitioner will make the final decision.