Mounjaro KwikPen 15mg solution for injection in pre-filled pen

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

Mounjaro is a medicine that contains an active substance called tirzepatide.

Mounjaro is used to treat adults with type 2 diabetes mellitus by reducing the level of sugar in the body only when the levels of sugar are high.

Mounjaro is also used for weight loss and weight maintenance in adults. Mounjaro primarily works by regulating your appetite, giving you a sense of satiety (‘fullness’), making you feel less hungry and experience less food cravings. This will 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.

It is important to continue to follow the advice on diet and exercise given to you by your doctor, pharmacist or nurse.

Mounjaro is also used together with reduced-calorie diet and increased physical activity 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.

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

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

• 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.

If you know that you are due to have surgery where you will be under anaesthesia (sleeping), please tell your doctor that you are taking Mounjaro.

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

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

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

If you are a woman with obesity or overweight and are using oral contraceptives, you should consider also using a barrier method of contraception (e.g., a condom) or switching to a non-oral contraceptive method for 4 weeks after starting Mounjaro and for 4 weeks after each increase in dose.

It is unknown whether tirzepatide passes into breast milk. A risk to newborns/infants cannot be ruled out. If you are breast-feeding or are planning to breast-feed, talk to your doctor before using this medicine. You and your doctor should decide if you should stop breast-feeding or delay using Mounjaro.

It is unlikely that this medicine will affect your ability to drive and use machines. However, if you use Mounjaro in combination with a sulphonylurea or insulin, low blood sugar (hypoglycaemia) may occur which may reduce your ability to concentrate. Avoid driving or using machines if you get any signs of low blood sugar, e.g. headache, drowsiness, weakness, dizziness, feeling hungry, confusion, irritability, fast heartbeat and sweating (see section 4). See section 2, ‘Warnings and precautions’ for information on increased risk of low blood sugar. Talk to your doctor for further information.

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

Each multiple-dose pre-filled pen contains 5.4 mg Benzyl Alcohol [E1519] in each 0.6 ml dose. Benzyl alcohol may cause allergic reactions.

Ask your doctor or pharmacist for advice if you have a liver or kidney disease. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).

• 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.

You can use your pen at 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 “Instructions for Use” 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.

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.

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.

Read the “Instructions for Use” for the pen carefully before using Mounjaro KwikPen.

If you are using Mounjaro with a sulphonylurea or insulin, it is important that you test your blood glucose levels as instructed by your doctor, pharmacist or nurse (see section 2, ‘Warnings and precautions’).

If you use more Mounjaro than you should talk to your doctor immediately. Too much of this medicine may cause low blood sugar (hypoglycaemia) and can make you feel sick or be sick.

If you forget to inject a dose and,

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

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

Do not stop using Mounjaro without talking with your doctor. If you stop using Mounjaro, and you have type 2 diabetes, your blood sugar levels can increase.

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 1 000 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.

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

• Low blood sugar (hypoglycaemia) when tirzepatide is used for the treatment of type 2 diabetes with medicines that contain a sulphonylurea and/or insulin. If you are using a sulphonylurea or insulin, the dose may need to be lowered while you use tirzepatide (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.
• Feeling sick (nausea) *
• Diarrhoea*
• Being sick (vomiting) – this usually goes away over time**
• Constipation**.

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

**Constipation and vomiting are very common when used for weight management, but common when used for type 2 diabetes.

Common (may affect up to 1 in 10 people)

• Low blood sugar (hypoglycaemia) when tirzepatide is used for type 2 diabetes with both metformin and a sodium-glucose co-transporter 2 inhibitor (another diabetes medicine)
  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.
• Allergic reaction (hypersensitivity) (e.g., rash, itching, and eczema)
• Dizziness observed in patients treated for weight management
• Low blood pressure observed in patients treated for weight management
• Feeling less hungry (decreased appetite) observed in patients treated for type 2 diabetes
• Stomach (abdominal) pain
• Indigestion (dyspepsia)
• Bloating of the stomach
• Burping (eructation)
• Gas (flatulence)
• Reflux or heartburn (also called gastroesophageal reflux disease – GORD) - a disease caused by stomach acid coming up into the tube from your stomach to your mouth
• Hair loss observed in patients treated for weight management
• Feeling tired (fatigue)
• Injection site reactions (e.g. itching or redness)
• Fast pulse¹
• Increased levels of pancreatic enzymes (such as lipase and amylase²) in blood.

¹Fast pulse is a common side effect when used for type 2 diabetes and uncommon when used for weight management.

²Increased levels of amylase is uncommon in weight management.

Uncommon (may affect up to 1 in 100 people)

• Low blood sugar (hypoglycaemia) when tirzepatide is used with metformin for type 2 diabetes. 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.
• Gallstones
• Weight loss observed in patients treated for type 2 diabetes
• Injection site pain
• Increased calcitonin levels in blood
• Cholecystitis (infection of the gallbladder) observed in patients treated for weight management
• Changed sense of taste

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

The active substance is tirzepatide.

• Mounjaro 2.5 mg KwikPen: Each multiple-dose pre-filled pen contains 4 doses of 0.6 ml solution which can be administered. Each dose (0.6 ml) contains 2.5 mg of tirzepatide.
• Mounjaro 5 mg KwikPen: Each multiple-dose pre-filled pen contains 4 doses of 0.6 ml solution which can be administered. Each dose (0.6 ml) contains 5 mg of tirzepatide.
• Mounjaro 7.5 mg KwikPen: Each multiple-dose pre-filled pen contains 4 doses of 0.6 ml solution which can be administered. Each dose (0.6 ml) contains 7.5 mg of tirzepatide.
• Mounjaro 10 mg KwikPen: Each multiple-dose pre-filled pen contains 4 doses of 0.6 ml solution which can be administered. Each dose (0.6 ml) contains 10 mg of tirzepatide.
• Mounjaro 12.5 mg KwikPen: Each multiple-dose pre-filled pen contains 4 doses of 0.6 ml solution which can be administered. Each dose (0.6 ml) contains 12.5 mg of tirzepatide.
• Mounjaro 15 mg KwikPen: Each multiple-dose pre-filled pen contains 4 doses of 0.6 ml solution which can be administered. Each dose (0.6 ml) contains 15 mg of tirzepatide.

The other ingredients are sodium phosphate dibasic heptahydrate, benzyl alcohol, glycerol, phenol, sodium chloride, sodium hydroxide (see section 2 under ‘Mounjaro contains sodium’ for further information); concentrated hydrochloric acid and water for injections.

Mounjaro is a clear, colourless to slightly yellow, solution for injection in a pre-filled KwikPen.

Each pre-filled KwikPen contains 4 doses of 0.6ml which can be administered. Any excess solution in the pen after use should be discarded.

The pre-filled KwikPen is for multiple-dose. Each pre-filled KwikPen contains 4 doses.

Pack sizes of 1 and 3 pre-filled KwikPens. Not all pack sizes may be available in your country.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: