Mounjaro 2,5 mg/5 mg/7,5 mg/10 mg/12,5 mg/15 mg Solution

MOUNJARO contains an active substance called tirzepatide and is used to treat adults with type 2 diabetes mellitus. MOUNJARO reduces the level of sugar in the body only when the levels of sugar are high. MOUNJARO is also used to treat adults with obesity or overweight (with BMI of at least 27 kg/m2). MOUNJARO influences appetite regulation, which may help you eat less food and reduce your body weight. In type 2 diabetes, MOUNJARO is used:

• on its own when you can’t take metformin (another diabetes medicine).
• with other medicines for diabetes when they are not enough to control your blood sugar levels. These other medicines may be medicines taken by mouth and/or insulin given by injection.

MOUNJARO is also used together with diet and exercise for weight loss and to help keep the weight under control in adults, who have:

• a BMI of 30 kg/m² or greater (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 levels of fats in the blood, breathing problems during sleep called ‘obstructive sleep apnoea’ or a history of heart attack, stroke or blood vessel problems)

BMI (Body Mass Index) is a measure of your weight in relation to your height. It is important to continue to follow the advice on diet and exercise given to you by your doctor, pharmacist or nurse.

Do not use MOUNJARO if you:

• are allergic to tirzepatide or to any of the other ingredients of MOUNJARO (listed in section 6)
• or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using MOUNJARO if:

• you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• you have severe problems with food digestion or food remaining in your stomach for longer than normal (including severe gastroparesis).
• you have ever had pancreatitis (inflammation of the pancreas which may cause severe pain in the stomach and back which does not go away).
• you have a problem with your eyes (diabetic retinopathy or macular oedema).
• you are using a sulphonylurea (another diabetes medicine) or insulin for your diabetes, as low blood sugar (hypoglycaemia) can occur. Your doctor may need to change your dose of these other medicines to reduce this risk.

When starting treatment with MOUNJARO, in some cases you may experience loss of fluids/dehydration, e.g. due to vomiting, nausea and/or diarrhoea, which may lead to a decrease in kidney function. It is important to avoid dehydration by drinking plenty of fluids. Contact your doctor if you have any questions or concerns.

Children and adolescents

MOUNJARO should not be given to 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, pharmacist or nurse if you are using, have recently used or might use any other medicines. (this includes complementary or traditional medicines)

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other healthcare professional for advice before taking MOUNJARO.

Pregnancy

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using MOUNJARO. MOUNJARO should not be used during pregnancy as the effects on an unborn child are not known. Therefore, it is recommended to use contraception while using MOUNJARO.

Breastfeeding

You should not breastfeed your infant when taking MOUNJARO. It is unknown whether tirzepatide passes into breast milk. A risk to newborns/infants cannot be ruled out.

Do not share medicines prescribed for you with any other person. Always use MOUNJARO exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure how to use MOUNJARO.

How much to use

The starting 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 by 2, 5 mg increments to 7, 5 mg, 10 mg, 12, 5 mg or 15 mg once a week if you need it. In each case your doctor will tell you to stay on a particular dose for at least 4 weeks before going to a higher dose. Do not change your dose unless your doctor has told you to.

Each pen or vial contains one dose of MOUNJARO either 2,5 mg, 5 mg, 7,5 mg, 10 mg, 12,5 mg, or 15 mg. Each KwikPen contains 4 doses of MOUNJARO either 2,5 mg, 5 mg, 7,5 mg, 10 mg, 12,5 mg, or 15 mg.

Choosing when to give MOUNJARO

You can use your MOUNJARO any time of the day, with or without meals. You should use it on the same day each week if you can. To help you remember, when to use MOUNJARO, you may wish to tick the day of the week when you inject your first dose on the box that your pen comes in, or mark it on a calendar. If necessary, you can change the day of your weekly MOUNJARO injection, as long as it has been at least 3 days since your last injection. After selecting a new dosing day, continue with once-a-week dosing on that new day.

How to inject MOUNJARO

Always use MOUNJARO exactly as your doctor has told you. Before you begin using MOUNJARO, always read the “Instructions for Use” carefully and talk to your doctor, pharmacist or nurse if you are not sure about how to inject MOUNJARO correctly. MOUNJARO is injected under the skin (subcutaneous injection) of your stomach area (abdomen) or upper leg (thigh) or upper arm. You may need help from someone else if you want to inject in your upper arm. Do not inject MOUNJARO directly into a vein, as this will change its action. If you want to do so, you can use the same area of your body each week. But be sure to choose a different injection site within that area. If you also inject insulin choose a different injection site for that injection. If you are blind or visually impaired, you will need help from someone to make your injection. Read the “Instructions for Use”, included in the pack, carefully before using MOUNJARO.

Not all side effects reported for MOUNJARO are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking MOUNJARO, please consult your doctor, pharmacist or other healthcare professional for advice.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

Uncommon (may affect up to 1 in 100 people)

• Inflamed pancreas (acute pancreatitis) which could cause severe pain in the stomach and back which does not go away. You should see a doctor immediately if you experience such symptoms.

Rare (may affect up to 1 in 1000 people)

• Severe allergic reactions (e.g. anaphylactic reaction, angioedema). You should get immediate medical help and inform your doctor if you experience symptoms such as breathing problems, rapid swelling of the lips, tongue and/or throat with difficulty swallowing and a fast heartbeat. These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

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

• Feeling sick (nausea)
• Diarrhoea
• Stomach (abdominal) pain reported in patients treated for weight management
• Being sick (vomiting) reported in patients treated for weight management
• Constipation reported in patients treated for weight management

These side effects are usually not severe. They are most common when first starting MOUNJARO but decrease over time in most patients.

Low blood sugar (hypoglycaemia) is very common when MOUNJARO is used with medicines that contain a sulphonylurea and/or insulin. If you are using a sulphonylurea or insulin for type 2 diabetes, the dose may need to be lowered while you use MOUNJARO (see section 2, ‘Warnings and precautions’). Symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, feeling hungry, confusion, irritability, fast heartbeat and sweating. Your doctor should tell you how to treat low blood sugar.

Common (may affect up to 1 in 10 people)

• Low blood sugar (hypoglycaemia) when MOUNJARO is used for type 2 diabetes with both metformin and a sodium-glucose co-transporter 2 inhibitor (another diabetes medicine)
• Allergic reaction (hypersensitivity) (e.g., rash, itching, and eczema)
• Dizziness reported in patients treated for weight management
• Low blood pressure reported in patients treated for weight management
• Feeling less hungry (decreased appetite) reported in patients treated for type 2 diabetes

Uncommon (may affect up to 1 in 100 people)

• Low blood sugar (hypoglycaemia) when MOUNJARO is used with metformin for type 2 diabetes.
• Gallstones
• Inflammation of the gallbladder
• Weight loss reported in patients treated for type 2 diabetes
• Injection site pain
• Increased calcitonin levels in blood.
• Changed sense of taste

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of MOUNJARO. Alternately, report suspected adverse events to the company at: [email protected]

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 label and on the carton after EXP. The expiry date refers to the last day of that month. Store in a refrigerator (2 °C to 8 °C). Do not freeze. If the pen has been frozen, DO NOT USE. Do not use MOUNJARO if you notice that the pen, vial, seal or stopper is damaged, or the medicine is cloudy, discoloured or has particles in it. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Pre-filled pen or Vial, single-dose:

Store in the original packaging to protect from light. MOUNJARO can be stored unrefrigerated below 30 ºC for up to 21 cumulative days and then the pen or vial must be discarded.

Pre-filled pen (KwikPen), multi-dose:

MOUNJARO KwikPen can be stored unrefrigerated below 30 ºC for up to 30 days after first use and then the pen must be discarded.