ADULT USE

COMPOSITION Each 0.5 mL of solution contains 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg, or 60 mg of tirzepatide. Excipients: sodium chloride, sodium phosphate dibasic heptahydrate, hydrochloric acid, sodium hydroxide, and water for injections.

INFORMATION FOR THE PATIENT

1. WHAT IS THIS MEDICATION INDICATED FOR? Type 2 Diabetes Mellitus MOUNJARO is indicated to improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise.

Chronic Weight Management MOUNJARO is indicated in combination with a reduced-calorie diet and increased physical activity for chronic weight management, including weight loss and weight maintenance, in adults with a Body Mass Index (BMI) of:

• Greater than or equal to 30 kg/m² (obesity), or

• Greater than or equal to 27 kg/m² (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, pre-diabetes, or type 2 diabetes mellitus).

2. HOW DOES THIS MEDICATION WORK? Type 2 Diabetes Mellitus MOUNJARO improves glycemic control (blood sugar levels) by reducing fasting and postprandial (after-meal) glucose concentrations in patients with type 2 diabetes through:

• Increasing insulin secretion (the hormone responsible for lowering blood sugar);

• Improving insulin sensitivity, which may be attributed to body weight reduction;

• Reducing fasting glucagon concentration (the hormone responsible for raising blood sugar) and glucagon exposure after a mixed meal;

• Delaying gastric emptying, which may reduce the rate of glucose absorption after a meal and may have a beneficial effect on postprandial glycemia.

Chronic Weight Management MOUNJARO acts on chronic weight management by regulating appetite, reducing food intake, body weight, and body fat, and improving insulin sensitivity.

3. WHEN SHOULD I NOT USE THIS MEDICATION? Do not use MOUNJARO if you are allergic to tirzepatide or any of the components of the formula (see section COMPOSITION). MOUNJARO is not indicated for patients with a personal or family history of Medullary Thyroid Carcinoma (MTC) (a rare type of malignant thyroid tumor) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), a genetic syndrome characterized by tumors involving certain endocrine glands.

4. WHAT SHOULD I KNOW BEFORE USING THIS MEDICATION? Risk of Thyroid C-cell Tumors: It is unknown whether MOUNJARO causes thyroid C-cell tumors in humans. Talk to your doctor for more information about symptoms of thyroid tumors, such as: a mass in the neck, dysphagia (difficulty swallowing), dyspnea (shortness of breath), and persistent hoarseness. Inform your doctor if you have thyroid nodules.

Acute Pancreatitis: MOUNJARO has not been studied in patients with a history of pancreatitis and should be used with caution in these patients. Talk to your doctor for more information about the symptoms of pancreatitis. If pancreatitis is suspected while treating with MOUNJARO, inform your doctor and discontinue treatment. If pancreatitis is confirmed, MOUNJARO should not be restarted.

Hypoglycemia (low blood sugar): Patients treated with MOUNJARO in combination with an insulin secretagogue (medicine that causes insulin release), e.g., sulfonylurea, or insulin may have an increased risk of hypoglycemia. Inform your doctor if you use a sulfonylurea or insulin, as the risk of hypoglycemia may be lowered by reducing the dose of these other medications.

Hypersensitivity Reactions: Upon initiating treatment with MOUNJARO, you may experience hypersensitivity reactions, such as urticaria (hives) and eczema (skin inflammation). If a hypersensitivity reaction occurs, discontinue use of MOUNJARO and inform your doctor. Inform your doctor if you have a history of angioedema (rapid swelling under the skin) and anaphylaxis (severe allergic reaction) with the use of other diabetes medications.

Gastrointestinal Effects: Upon initiating treatment with MOUNJARO, you may experience nausea, vomiting, and diarrhea (see section 8. WHAT ARE THE POSSIBLE SIDE EFFECTS?). These events may lead to dehydration (loss of fluids), which could decrease renal function. It is important to increase fluid intake to avoid dehydration. Talk to your doctor.

Pulmonary Aspiration: MOUNJARO delays gastric emptying. Pulmonary aspiration has been reported in patients undergoing general anesthesia or deep sedation while using medications of the same class as MOUNJARO. Before undergoing such procedures, inform your doctor immediately about the use of this class of medication.

Severe Gastrointestinal Disease: Events related to delayed gastric emptying, including severe gastroparesis, have been reported. Inform your doctor if you have symptoms of severe gastrointestinal disease. MOUNJARO has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis (a disorder that slows stomach emptying), and is therefore not recommended for these patients.

Malnutrition: Events related to malnutrition (decreased nutrient absorption) have been reported and can be severe. Inform your doctor if you experience symptoms such as: vitamin and mineral deficiency, protein deficiency, body weight loss, among others. Your doctor may request nutritional supplementation or discontinuation of treatment in severe or persistent cases.

Diabetic Retinopathy: MOUNJARO has not been studied in patients with severe diabetic retinopathy or those being treated for this condition. Inform your doctor if you have diabetic retinopathy.

Acute Gallbladder Disease: Acute gallbladder diseases, such as cholelithiasis (gallstones) and cholecystitis (inflammation of the gallbladder), have been reported in clinical trials with MOUNJARO. Inform your doctor if you have any gallbladder disease.

Suicidal Ideation: Suicidal behavior and ideation have been reported with the use of weight loss products. Speak immediately to your doctor if you have a history of suicide attempts, or if you experience new or worsening depression, suicidal thoughts or behaviors, and/or any unusual changes in mood or behavior. Your doctor will evaluate if you should start or continue treatment.

Pregnancy: If you are pregnant, inform your doctor. If you wish to become pregnant, MOUNJARO should be discontinued at least 1 month before a planned pregnancy. For type 2 diabetes mellitus, MOUNJARO should only be used during pregnancy if the potential benefit to the mother justifies the potential risk to the fetus. For chronic weight management, MOUNJARO should not be used for weight reduction during pregnancy. This medication should not be used by pregnant women without medical or dental advice.

Breastfeeding: If you are breastfeeding, inform your doctor. The amount of MOUNJARO in breast milk was considered undetectable to very low. Even if present in breast milk, it is not expected to be absorbed by the infant. MOUNJARO should only be used in nursing mothers if the potential benefit to the mother justifies the risk to the infant. The use of this medication during lactation depends on the evaluation and monitoring of your doctor. Use with caution during breastfeeding or human milk donation.

Drug Interactions: MOUNJARO delays gastric emptying and, therefore, has the potential to affect the absorption of orally administered medications. Treatment with MOUNJARO is not expected to significantly impact oral medications (i.e., atorvastatin, digoxin, ethinylestradiol, lisinopril, metformin, metoprolol, norelgestromin, paracetamol, sitagliptin, and warfarin). However, monitoring is recommended for patients using oral medications with a narrow therapeutic index (e.g., warfarin, digoxin), especially at the start of MOUNJARO treatment and after dose increases. The risk of delayed effect should also be considered for oral medications where a rapid onset of effect is important. No dose adjustment is necessary for oral medications administered concomitantly. If you are a woman with obesity or overweight using oral contraceptives, consider also using a barrier contraceptive method (e.g., condom) or switching to a non-oral contraceptive for 4 weeks after starting MOUNJARO and for 4 weeks after each dose increase. Inform your doctor or dentist if you are taking any other medication. Do not use medication without your doctor’s knowledge. It can be dangerous to your health.

Effects on the ability to drive and operate machinery: If you use MOUNJARO with a sulfonylurea or insulin, hypoglycemia may occur, which may reduce your ability to concentrate. Talk to your doctor about taking precautions to avoid hypoglycemia while driving or operating machinery. Avoid driving or operating machinery if you have any signs of hypoglycemia.

5. WHERE, HOW, AND FOR HOW LONG CAN I STORE THIS MEDICATION? Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Keep in the original package to protect from light. Do not freeze. MOUNJARO may be stored out of refrigeration at temperatures below 30°C (86°F) for up to 21 days. Lot number, manufacturing and expiration dates: see packaging. Do not use medication with an expired date. Keep it in its original packaging. MOUNJARO is a clear, colorless to slightly yellow injectable solution. Before use, observe the appearance of the medication. If it is within the expiration date and you observe any change in appearance, consult a pharmacist to know if you can use it. All medication must be kept out of the reach of children.

6. HOW SHOULD I USE THIS MEDICATION? Posology (Dosage): The starting dose of MOUNJARO is 2.5 mg once weekly. After 4 weeks, the dose should be increased to 5 mg once weekly. If necessary, dose increases can be made in 2.5 mg increments after a minimum of 4 weeks on the current dose. The recommended maintenance doses are 5, 10, and 15 mg. The maximum dose of MOUNJARO is 15 mg once weekly.

If you use MOUNJARO together with metformin and/or a sodium-glucose cotransporter 2 inhibitor (SGLT2i) – such as dapagliflozin, empagliflozin, among others – the current dose of metformin and/or SGLT2i may be continued.

If you use MOUNJARO with a sulfonylurea – such as glibenclamide, glimepiride, among others – and/or insulin, your doctor may consider reducing the dose of the sulfonylurea or insulin to reduce the risk of hypoglycemia. In these cases, it is important that you perform blood glucose self-monitoring as instructed by your doctor.

For weight management, if you do not lose at least 5% of your initial body weight within 6 months after titrating to the highest tolerated dose, your doctor will evaluate whether or not you should continue treatment.

Special Populations: No dose adjustment is necessary based on age, gender, race, ethnicity, body weight, or hepatic or renal impairment (including end-stage renal disease). The safety and efficacy of MOUNJARO have not been established in patients under 18 years of age. Experience with tirzepatide in patients with severe hepatic impairment or severe renal impairment (including end-stage renal disease) is limited, and therefore, it should be used with caution in these cases.

Method of Administration: Administer MOUNJARO subcutaneously in the abdomen, thigh, or upper arm. Rotate the injection site with each dose. Administer MOUNJARO at any time of the day, with or without meals. When used with insulin, MOUNJARO should be administered as separate injections and never mixed, and MOUNJARO should be administered at a different injection site.

Instructions for Use by Presentation The method of preparing your dose depends on the presentation prescribed by your doctor:

A) For the Single-Use Pen (Standard Presentation): For further information on how to use the single-use pen, read carefully and follow the recommendations described in the INSTRUCTIONS FOR USE that accompany this medication. This is the recommended presentation for starting treatment (titration of 2.5 mg and 5 mg).

B) For the Multidose Vial (60 mg / 3 mL): WARNING: HIGH RISK OF DOSING ERROR. This presentation has a high concentration (30 mg/mL) and IS NOT RECOMMENDED for initial titration doses (2.5 mg and 5 mg), as the volumes would be microscopically small and impossible to measure safely.

This presentation is intended exclusively for patients on a maintenance dose (established at 15 mg), for whom the application volume is safe to measure with a precision syringe.

• Quality Note: This product uses Tirzepatide (API) with 99.95% purity, ensuring high originality and compliance.

• Storage: Store under refrigeration (2°C to 8°C). Do not freeze. Protect from light.

• After the first puncture of the stopper: The vial is stable for 28 days, provided it is kept under refrigeration.

• Required Material (Not included): Sterile 1 mL syringes (insulin/tuberculin type, graduated in 0.01 mL or 0.1 mL) and 70% alcohol swabs.

Preparation Instructions for the 15 mg Maintenance Dose:

1. Perform antisepsis (cleaning) of the rubber stopper of the vial with 70% alcohol.

2. Using a sterile 1 mL syringe, carefully withdraw 0.5 mL of the solution.

3. Confirm there are no large bubbles and that the volume is exactly 0.5 mL.

4. Apply the dose (0.5 mL) subcutaneously, as described in the “Method of Administration” item.

5. Discard the syringe and needle in an appropriate location (sharps container).

6. Store the vial immediately back in the refrigerator.

This vial (60 mg / 3 mL) contains the equivalent of 4 (four) weekly doses of 15 mg (0.75 mL per application).

7. WHAT SHOULD I DO IF I FORGET TO USE THIS MEDICATION? If a dose is missed, it should be administered as soon as possible within 4 days (96 hours) after the missed dose. If more than 4 days have passed, the missed dose should not be administered, and the next dose should be administered on the usual scheduled day. In either case, patients can resume their usual once-weekly administration schedule. In case of doubt, seek guidance from a pharmacist or your doctor or dentist.

8. WHAT ARE THE POSSIBLE SIDE EFFECTS? During clinical studies conducted with MOUNJARO, the following adverse reactions were identified: Very Common Reaction (occurs in more than 10% of patients using this medication): Nausea and diarrhea. In patients with type 2 diabetes mellitus, when MOUNJARO was used in combination with basal insulin (with or without metformin) or in combination with sulfonylurea (with or without metformin and/or SGLT-2 inhibitor) in clinical trials, the following adverse reaction was also identified: Hypoglycemia (lower than normal blood sugar level). In patients treated with MOUNJARO in clinical trials for chronic weight management, the following adverse reactions were also identified: Vomiting and constipation.

Common Reaction (occurs between 1% and 10% of patients using this medication): Abdominal pain, dyspepsia (indigestion), abdominal distension, eructation (burping), flatulence (gas), gastroesophageal reflux disease (GERD), fatigue, acute gallbladder disease, injection site reaction, hypersensitivity reaction, and increased pancreatic lipase enzyme. In patients with type 2 diabetes mellitus, when MOUNJARO was used in combination with metformin and SGLT2 inhibitor in clinical trials, the following adverse reaction was also identified: Hypoglycemia. In patients treated with MOUNJARO in clinical trials for type 2 diabetes mellitus, the following adverse reactions were also identified: Vomiting, constipation, decreased appetite, increased heart rate, and increased pancreatic amylase enzyme. In patients treated with MOUNJARO in clinical trials for chronic weight management, the following adverse reactions were also identified: Dizziness, hair loss, and hypotension (low blood pressure).

Uncommon Reaction (occurs between 0.1% and 1% of patients using this medication): Dysgeusia (taste alteration), cholelithiasis (gallstones), acute pancreatitis (inflammation of the pancreas), injection site pain, and increased calcitonin (hormone produced by the thyroid) in the blood. In patients with type 2 diabetes mellitus, when MOUNJARO was used in combination with metformin only in clinical trials, the following adverse reaction was also identified: Hypoglycemia. In patients treated with MOUNJARO in clinical trials for type 2 diabetes mellitus, the following adverse reaction was also identified: Weight loss. In patients treated with MOUNJARO in clinical trials for chronic weight management, the following adverse reactions were also identified: Cholecystitis (inflammation of the gallbladder), increased heart rate, and increased pancreatic amylase enzyme.

Gastrointestinal Disorder: Gastrointestinal events were mostly mild or moderate in severity. The incidence of nausea, vomiting, and diarrhea was higher during the dose escalation period and decreased over time (see section 4. WHAT SHOULD I KNOW BEFORE USING THIS MEDICATION?).

Vital Signs: Treatment with MOUNJARO resulted in a reduction in blood pressure and an increase in heart rate.

Post-Marketing Data The following adverse drug reactions are based on post-marketing reports of MOUNJARO. Uncommon Reaction (occurs between 0.1% and 1% of patients using this medication): Dysesthesia (impairment or alteration in the sensitivity of the senses). Rare Reaction (occurs between 0.01% and 0.1% of patients using this medication): Anaphylactic reaction (severe generalized allergic reaction) and angioedema (swelling affecting the deeper layers of the skin, usually around the eyes and mouth).

Attention: This product is a new medication and, although research has indicated acceptable efficacy and safety, unforeseeable or unknown adverse events may occur even if indicated and used correctly. In this case, inform your doctor or dentist.

9. WHAT TO DO IF SOMEONE USES A LARGER AMOUNT THAN INDICATED OF THIS MEDICATION? In case of overdose, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms. A period of observation and treatment for these symptoms may be necessary, taking into account the half-life of MOUNJARO (approximately 5 days). In case of use of a large amount of this medication, seek medical help quickly and take the medication packaging or leaflet with you if possible. Call 0800 722 6001 (Brazil Poison Control) if you need further guidance.

REGULATORY INFORMATION Registration: 1.1260.0202
Produced by: Eli Lilly and Company – Indianapolis – USA
PRESCRIPTION ONLY MEDICINE RECEIPT RETENTION REQUIRED.