MOUNJARO 5 mg INJECTABLE SOLUTION IN VIAL

Introduction

Package Leaflet: Information for the Patient

Mounjaro 2.5mg solution for injection in vial

Mounjaro 5mg solution for injection in vial

Mounjaro 7.5mg solution for injection in vial

Mounjaro 10mg solution for injection in vial

Mounjaro 12.5mg solution for injection in vial

Mounjaro 15mg solution for injection in vial

tirzepatida

• This medicinal product is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of the package leaflet contains information on how to report side effects.

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, nurse or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is Mounjaro and what is it used for
2. What you need to know before you use Mounjaro
3. How to use Mounjaro
4. Possible side effects
5. Storage of Mounjaro
6. Contents of the pack and other information

1. What is Mounjaro and what is it used for

Mounjaro contains the active substance tirzepatida and is used to treat adults with type 2 diabetes mellitus. Mounjaro lowers blood sugar levels only when blood sugar levels are high.

Mounjaro is also used to treat adults with obesity or overweight (with a BMI of at least 27 kg/m2). Mounjaro affects appetite regulation, which can help you eat less food and reduce your body weight.

In type 2 diabetes, Mounjaro is used:

• alone when you cannot take metformin (another diabetes medicine).
• or in combination with other diabetes medicines when these are not enough to control the sugar levels in your blood. These other medicines may be taken by mouth and/or may be an insulin injection.

Mounjaro is also used together with diet and exercise to lose weight and help keep weight under control in adults who have:

• a BMI of 30 kg/m² or more (obesity) or
• a BMI of at least 27 kg/m², but less than 30 kg/m² (overweight) and weight-related health problems (such as prediabetes, type 2 diabetes, high blood pressure, abnormal blood fat levels, breathing problems during sleep called "obstructive sleep apnea" or a history of heart attack, stroke or vascular problems)

Body Mass Index (BMI) is a measure of your weight in relation to your height.

In patients with obstructive sleep apnea (OSA) and obesity, Mounjaro can be used with or without positive airway pressure (PAP) therapy.

It is important that you follow the advice about your diet and physical activity that your doctor, nurse or pharmacist gives you.

2. What you need to know before you use Mounjaro

Do not use Mounjaro

• if you are allergic to tirzepatida or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, nurse or pharmacist before you start using Mounjaro if:

• you have severe problems with food digestion or food stays in your stomach for longer than usual (including severe gastroparesis).
• you have ever had pancreatitis (inflammation of the pancreas, which can cause severe stomach and back pain that does not go away).
• you have any eye problems (diabetic retinopathy or macular edema).
• you are taking a sulfonylurea (another diabetes medicine) or insulin for diabetes, as you may get low blood sugar (hypoglycemia). Your doctor may need to change the dose of these medicines to reduce this risk.

When you start treatment with Mounjaro, you may experience fluid loss/dehydration, such as vomiting, nausea and/or diarrhea, which can cause a decrease in kidney function. To avoid dehydration, it is important to drink plenty of fluids. Contact your doctor if you have any questions or concerns.

If you know you are going to have surgery that involves anesthesia (a state of sleep), tell your doctor that you are taking Mounjaro.

Children and adolescents

This medicine must not be used in children and adolescents under 18 years of age because it has not been studied in this age group.

Other medicines and Mounjaro

Tell your doctor, nurse or pharmacist if you are using, have recently used or might use any other medicines.

Pregnancy

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. This medicine must not be used during pregnancy as the effects of this medicine on the fetus are not known. Therefore, it is recommended to use contraceptive methods while using this medicine.

Breast-feeding

It is not known whether tirzepatida passes into breast milk. A risk to newborns/babies cannot be ruled out. If you are breast-feeding or plan to breast-feed, ask your doctor for advice before taking this medicine. You and your doctor must decide whether to stop breast-feeding or stop using Mounjaro.

Driving and using machines

This medicine is unlikely to affect your ability to drive or use machines. However, if you use Mounjaro in combination with a sulfonylurea or insulin, you may get low blood sugar (hypoglycemia) that can reduce your ability to concentrate. Avoid driving or using machines if you have any signs of low blood sugar, such as headache, drowsiness, weakness, dizziness, feeling hungry, confusion, irritability, rapid heartbeat and sweating (see section 4). See section 2, “Warnings and precautions” for information on the increased risk of getting low blood sugar. Ask your doctor for more information.

Mounjaro contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is essentially “sodium-free”.

3. How to use Mounjaro

Follow the instructions for administration of this medicine exactly as told by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist again.

How much to use

• The initial dose is 2.5 mg once a week for four weeks. After four weeks, your doctor will increase your dose to 5 mg once a week.

• Your doctor may increase your dose in increments of 2.5 mg up to 7.5 mg, 10 mg, 12.5 mg or 15 mg once a week if needed. In each case, your doctor will tell you to stay on a specific dose for at least 4 weeks before moving to a higher dose.

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

Each vial contains a single dose of Mounjaro of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg or 15 mg.

When to use Mounjaro

You can use Mounjaro at any time of day, with or without food. If you can, you should use it on the same day each week. To help you remember when to use Mounjaro, you can write down the day of the week when you inject your first dose on a calendar.

If necessary, you can change the day of your weekly Mounjaro injection, as long as at least 3 days have passed since your last injection. After selecting a new dosing day, continue with once-weekly administration on that new day.

How to inject Mounjaro

Follow the instructions for administration of Mounjaro exactly as told by your doctor. Before you start using Mounjaro, always read the “Instructions for use” carefully and ask your doctor, nurse or pharmacist if you are not sure how to inject Mounjaro correctly.

Mounjaro is injected under the skin (subcutaneous injection) of the abdomen or the top of the leg (thigh) or arm. You may need help from another person if you want to inject into the top of your arm. Do notinject Mounjaro directly into a vein, as this would change its action.

If you want, you can inject into the same area of your body each week. But in this case, make sure to choose different injection sites within the same area. If you also inject insulin, choose a different injection site for that injection. If you are blind or have visual impairments, you will need help from someone to perform your injection.

Instructions for use

1. First, wash your hands with water and soap.
2. Check that Mounjaro in the vial looks clear and colorless or slightly yellow. Do not use it if it is frozen, cloudy or has particles.
3. Remove the plastic protective cap from the vial, but do not remove the rubber stopper. Clean the vial stopper with a cotton swab and prepare a new syringe. Do not share or reuse your needle or syringe.
4. Put a small amount of air into the syringe. Insert the needle through the rubber stopper into the top of the Mounjaro vial and inject the air into the vial.
5. Turn the Mounjaro vial and syringe upside down and slowly pull the syringe plunger down to draw all of the Mounjaro solution out of the vial. The vial is filled to allow for the administration of a single 0.5 ml dose of Mounjaro.
6. If there are air bubbles in the syringe, gently tap it a few times to make the bubbles rise to the top. Slowly push the plunger up until there is no more air in the syringe.
7. Remove the syringe from the vial stopper.
8. Before you inject, clean your skin.
9. Pinch and gently hold a fold of skin where you will inject.

10.Inject under the skin, as you have been instructed. Inject all of the solution in the syringe to get a full dose. After the injection, the needle should remain under the skin for 5 seconds to make sure you get the full dose.

11.Remove the needle from your skin.

12.Throw away the vial, used needle and syringe right after each injection in a puncture-resistant container, or as your doctor, nurse or pharmacist tells you.

Monitoring of blood sugar levels

If you are using Mounjaro with a sulfonylurea or insulin, it is important that you monitor your blood sugar levels as your doctor, nurse or pharmacist tells you (see section 2, “Warnings and precautions”).

If you use more Mounjaro than you should

If you use more Mounjaro than you should, talk to your doctor right away. Too much medicine can make your blood sugar levels go too low (hypoglycemia) and can also make you feel sick to your stomach or throw up.

If you forget to use Mounjaro

If you forget to inject a dose and,

• it has been 4days or lesssince you should have used Mounjaro, use it as soon as you remember. Then inject your next dose as usual on your scheduled day.
• it has been more than 4dayssince you should have used Mounjaro, skip the missed dose. Then inject your next dose as usual on your scheduled day.

Do not inject a double dose to make up for a missed dose. The minimum time between two doses must be at least 3 days.

If you stop using Mounjaro

Do not stop using Mounjaro without talking to your doctor. If you stop using Mounjaro, and you have type 2 diabetes, your blood sugar levels may go up.

If you have any other questions about using this medicine, ask your doctor, nurse or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Uncommon(may affect up to 1 in 100 people)

• Pancreatitis (inflammation of the pancreas) that can cause severe stomach and back pain that does not go away. See your doctor right away if you get these symptoms.

Rare(may affect up to 1 in 1,000 people)

• Severe allergic reactions (e.g. anaphylactic reaction, angioedema). You must get medical help right away and tell your doctor if you get symptoms such as breathing problems, rapid swelling of the lips, tongue and/or throat with difficulty swallowing and rapid heartbeat.

Other side effects

Very common(may affect more than 1 in 10 people)

• Nausea
• Diarrhea
• Stomach pain (abdominal pain) reported in patients treated for weight control
• Vomiting reported in patients treated for weight control
• Constipation reported in patients treated for weight control

These side effects are usually not serious. Nausea, diarrhea, and vomiting are more common when you start using tirzepatida, but decrease over time in most patients.

• Low blood sugar (hypoglycemia) is very common when tirzepatida is used with other medicines that contain a sulfonylurea and/or insulin. If you are taking a sulfonylurea or insulin for type 2 diabetes, you may need to have your dose reduced while you use tirzepatida (see section 2, “Warnings and precautions”). Symptoms of low blood sugar can include headache, drowsiness, weakness, dizziness, feeling hungry, confusion, irritability, rapid heartbeat and sweating. Your doctor should tell you how to treat low blood sugar levels.

Common(may affect up to 1 in 10 people)

• Low blood sugar (hypoglycemia) when tirzepatida is used for type 2 diabetes with metformin together with a sodium-glucose cotransporter 2 (SGLT2) inhibitor (another diabetes medicine)
• Allergic reaction (hypersensitivity) (e.g. rash, itching and eczema)
• Dizziness reported in patients treated for weight control
• Low blood pressure reported in patients treated for weight control

• Decreased appetite reported in patients treated for type 2 diabetes
• Stomach pain (abdominal pain) reported in patients treated for type 2 diabetes
• Vomiting reported in patients treated for type 2 diabetes – usually decreases over time
• Indigestion (dyspepsia)
• Constipation reported in patients treated for type 2 diabetes
• Bloating
• Belching
• Gas (flatulence)
• Acid reflux or heartburn (also called gastroesophageal reflux disease – GERD) – a disease caused by stomach acid flowing back up into the tube that connects the stomach to the mouth

• Hair loss reported in patients treated for weight control
• Fatigue
• Injection site reactions (e.g. itching or redness)
• Rapid heartbeat

• Increased levels of pancreatic enzymes (such as lipase and amylase) in blood.
• Increased levels of calcitonin in blood in patients treated for weight control.

Uncommon(may affect up to 1 in 100 people)

• Low blood sugar (hypoglycemia) when tirzepatida is used with metformin for type 2 diabetes
• Gallstones
• Gallbladder inflammation
• Weight loss reported in patients treated for type 2 diabetes
• Pain at the injection site
• Increased levels of calcitonin in blood in patients treated for type 2 diabetes or for OSA with obesity
• Altered sense of taste
• Changed skin sensitivity
• Delayed emptying of the stomach

Reporting of side effects

If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Mounjaro

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the vial label and on the carton after EXP. The expiry date is the last day of the month stated.

Store in a refrigerator (between 2°C and 8°C). Do not freeze. If the vial has been frozen, DO NOT USE IT.

Keep the vial in the original package to protect it from light.

Mounjaro can be stored without refrigeration below 30°C for up to 21 consecutive days, after which the vial must be discarded.

Do not use this medicine if you notice that the vial, seal or stopper is damaged, or if the medicine is cloudy, discolored or contains particles.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container contents and additional information

Mounjaro composition

The active ingredient is tirzepatida.

• Mounjaro 2.5mg:Each vial contains 2.5 mg of tirzepatida in 0.5 ml of solution (5 mg/ml).
• Mounjaro 5mg:Each vial contains 5 mg of tirzepatida in 0.5 ml of solution (10 mg/ml).
• Mounjaro 7.5mg:Each vial contains 7.5 mg of tirzepatida in 0.5 ml of solution (15 mg/ml).
• Mounjaro 10mg:Each vial contains 10 mg of tirzepatida in 0.5 ml of solution (20 mg/ml).
• Mounjaro 12.5mg:Each vial contains 12.5 mg of tirzepatida in 0.5 ml of solution (25 mg/ml).
• Mounjaro 15mg:Each vial contains 15 mg of tirzepatida in 0.5 ml of solution (30 mg/ml).

The other components are disodium hydrogen phosphate heptahydrate (E339), sodium chloride, sodium hydroxide (for more information, see section 2 "Mounjaro contains sodium"), concentrated hydrochloric acid, and water for injectable preparations.

Product appearance and container contents

Mounjaro is a clear, colorless to slightly yellowish injectable solution in a vial.

Each vial contains 0.5 ml of solution.

The vial is for single use.

Packaging of 1 vial, 4 vials, 12 vials, multiple packaging of 4 vials (4 packs of 1) or multiple packaging of 12 vials (12 packs of 1). Not all pack sizes may be marketed.

This packaging does not contain needles or syringes.

Marketing authorization holder

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Netherlands.

Manufacturer

Eli Lilly Italia S.p.A., Via Gramsci 731/733, 50019, Sesto Fiorentino, Florence (FI), Italy.

Lilly S.A., Avda. de la Industria, 30, 28108 Alcobendas, Madrid, Spain.

For more information on this medicinal product, please contact the local representative of the marketing authorization holder:

Date of last revision of this prospectus:

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu, and on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).