MOUNJARO contains the active ingredient tirzepatide, a GIP and GLP-1 receptor agonist. It is a clear, colorless to slightly yellow solution intended for subcutaneous injection, available in single-dose pens or vials with strengths of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg per 0.5 mL. Key inactive ingredients include sodium chloride, sodium phosphate dibasic heptahydrate, and water for injection.

How should I use this medication?

This medication is injected under the skin. You will be taught how to prepare and give it. It is given once every week (every 7 days). Keep taking it unless your health care provider tells you to stop. If you use this medication with insulin, you should inject this medication and the insulin separately. Do not mix them together. Do not give the injections right next to each other. Change (rotate) injection sites with each injection. This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions. It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or care team to get one. A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time. Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can unless it is more than 4 days (96 hours) late. If it is more than 4 days late, skip the missed dose. Take the next dose at the normal time. Do not take 2 doses within 3 days of each other.

Where should I keep my medication?

Keep out of the reach of children and pets. Refrigeration (preferred): Store in the refrigerator. Keep this medication in the original carton until you are ready to take it. Do not freeze. Protect from light. Get rid of opened vials after use, even if there is medication left. Get rid of any unopened vials or pens after the expiration date. Room Temperature: This medication may be stored at room temperature below 30 degrees C (86 degrees F) for up to 21 days. Keep this medication in the original carton until you are ready to take it. Protect from light. Avoid exposure to extreme heat. Get rid of opened vials after use, even if there is medication left. Get rid of any unopened vials or pens after 21 days, or after they expire, whichever is first. To get rid of medications that are no longer needed or have expired: -Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location. -If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -Change in vision -Dehydration—increased thirst, dry mouth, feeling faint or lightheaded, headache, dark yellow or brown urine -Fast or irregular heartbeat -Gallbladder problems—severe stomach pain, nausea, vomiting, fever -Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet -Pancreatitis—severe stomach pain that spreads to your back or gets worse after eating or when touched, fever, nausea, vomiting -Thyroid cancer—new mass or lump in the neck, pain or trouble swallowing, trouble breathing, hoarseness Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome): -Constipation -Diarrhea -Loss of appetite -Nausea -Upset stomach

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -Eye disease caused by diabetes -Gallbladder disease -Have or have had pancreatitis -Having surgery -Kidney disease -Personal or family history of MEN 2, a condition that causes endocrine gland tumors -Personal or family history of thyroid cancer -Stomach or intestine problems, such as problems digesting food -An unusual or allergic reaction to tirzepatide, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breastfeeding

What may interact with this medication?

-Alcohol -Antiviral medications for HIV or AIDS -Aspirin and aspirin-like medications -Beta blockers, such as atenolol, metoprolol, propranolol -Certain medications for blood pressure, heart disease, irregular heart beat -Chromium -Clonidine -Diuretics -Estrogen or progestin hormones -Fenofibrate -Gemfibrozil -Guanethidine -Isoniazid -Lanreotide -Male hormones or anabolic steroids -MAOIs, such as Marplan, Nardil, and Parnate -Medications for weight loss -Medications for allergies, asthma, cold, or cough -Medications for depression, anxiety, or mental health conditions -Niacin -Nicotine -NSAIDs, medications for pain and inflammation, such as ibuprofen or naproxen -Octreotide -Other medications for diabetes, such as glyburide, glipizide, or glimepiride -Pasireotide -Pentamidine -Phenytoin -Probenecid -Quinolone antibiotics, such as ciprofloxacin, levofloxacin, ofloxacin -Reserpine -Some herbal dietary supplements -Steroid medications, such as prednisone or cortisone -Sulfamethoxazole; trimethoprim -Thyroid hormones -Warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse. You may need blood work done while you are taking this medication. Your care team will monitor your HbA1C (A1C). This test shows what your average blood sugar (glucose) level was over the past 2 to 3 months. Know the symptoms of low blood sugar and know how to treat it. Always carry a source of quick sugar with you. Examples include hard sugar candy or glucose tablets. Make sure others know that you can choke if you eat or drink if your blood sugar is too low and you are unable to care for yourself. Get medical help at once. Tell your care team if you have high blood sugar. Your medication dose may change if your body is under stress. Some types of stress that may affect your blood sugar include fever, infection, and surgery. Do not share pens or cartridges with anyone, even if the needle is changed. Each pen should only be used by one person. Sharing could cause an infection. Wear a medical ID bracelet or chain. Carry a card that describes your condition. List the medications and doses you take on the card. Talk to your care team about your risk of cancer. You may be more at risk for certain types of cancer if you take this medication. Talk to your care team right away if you have a lump or swelling in your neck, hoarseness that does not go away, trouble swallowing, shortness of breath, or trouble breathing. Make sure you stay hydrated while taking this medication. Drink water often. Eat fruits and veggies that have a high water content. Drink more water when it is hot or you are active. Talk to your care team right away if you have fever, infection, vomiting, diarrhea, or if you sweat a lot while taking this medication. The loss of too much body fluid may make it dangerous for you to take this medication. If you are going to need surgery or a procedure, tell your care team that you are taking this medication. Estrogen and progestin hormones that you take by mouth may not work as well while you are taking this medication. Switch to a non-oral contraceptive or add a barrier contraceptive for 4 weeks after starting this medication and after each dose increase. Talk to your care team about contraceptive options. They can help you find the option that works for you. Do not take this medication without first talking to your care team if you may be or could become pregnant. Your care team can help you find the option that works for you. Weight loss is not recommended during pregnancy. Maintaining healthy blood sugar levels can help reduce the risk of pregnancy complications. Talk to your care team if you are breastfeeding. When recommended, this medication may be taken. Its use during breastfeeding has not been well studied. Lactation may help lower your blood sugar levels. Your care team may recommend changes to your treatment plan.

What are the most serious risks of this medication?

This medication may increase the risk of thyroid tumors or cancer. Do not take this medication if you or a family member has or have had multiple endocrine neoplasia (MEN) 2 or a type of thyroid cancer called medullary thyroid carcinoma (MTC). Talk to your care team right away if you have a lump or swelling in the neck, pain or trouble swallowing, trouble breathing, or hoarseness.