MOUNJARO INJECTION SOLUTION 2.5 mg/0.5 mL

▼This drug is subject to additional monitoring. This triangle will enable rapid identification of new safety information. You can help by reporting any side effects that occur. To learn how to report side effects, see the end of Chapter 4.

Excipients: Dibasic sodium phosphate heptahydrate, sodium chloride, sodium hydroxide solution, hydrochloric acid solution and water for injection (for pH adjustment).

Before you start using this medicine, read this INSTRUCTIONS FOR USE carefully, because it contains important information for you.

MOUNJARO is a clear, colorless to slightly yellow solution for injection presented in a vial. Each vial contains 0.5 mL of solution and each vial is for single use only. Packages contain 1 or 4 vials. Needle tips and syringes are not included in the packaging.

MOUNJARO contains an active ingredient called tirzepatide and is used to treat adults with poorly controlled diabetes (type 2 diabetes). MOUNJARO only reduces sugar levels in the body when sugar levels are high.

MOUNJARO is also used to treat adults with obesity or overweight (BMI of at least 27 kg/m2). MOUNJARO affects the regulation of appetite, which may help you eat less and lose weight.

MOUNJARO is used in type 2 diabetes in the following conditions:

MOUNJARO is also used, along with diet and exercise, to help lose weight and keep body weight under control in adults who:

Always use this medicine as recommended by your doctor or pharmacist. If you are not sure how to use this medicine, consult your doctor or pharmacist.

The starting dose is 2.5 mg once a week for four weeks. After four weeks, your doctor will be expected to increase the dose to 5 mg once a week.

If necessary, your doctor may increase the dose to 7.5 mg, 10 mg, 12.5 mg or 15 mg in 2.5 mg increments once a week. In all cases, you should stay at the current dose for at least 4 weeks before switching to a higher dose.

Recommended maintenance doses are 5, 10 and 15 mg.

Do not change the dose you use unless your doctor tells you to.

Like all medicines, MOUNJARO may have side effects in people who are sensitive to its ingredients.

If any of the following occur, stop using MOUNJARO and IMMEDIATELY inform your doctor or go to the emergency department of your nearest hospital.

These are all very serious side effects.

If you have one of these, it means you have a serious allergy to MOUNJARO. You may need emergency medical attention or hospitalization.

These side effects are usually not severe. Feeling nauseous, diarrhea and vomiting are the most common side effects when first starting tirzepatide and subside over time in most patients.