Patient leaflet - Mounjaro 10 mg solution for injection in vial
1. What Mounjaro is and what it is used for
What Mounjaro is
Mounjaro is a medicine that contains an active substance called tirzepatide.
Mounjaro is used to treat adults, adolescents and children aged 10 years and above with type 2 diabetes mellitus by reducing the level of sugar in the body only when the levels of sugar are high. Mounjaro can also help prevent heart disease in adults with type 2 diabetes mellitus.
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.
What Mounjaro is used for
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’ (OSA) 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.
2. What you need to know before you use Mounjaro
Do not use Mounjaro
- If you are allergic to tirzepatide or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
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; see section 4).
- 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 using Mounjaro.
Children and adolescents
This medicine can be used in children aged 10 years and older for the treatment of type 2 diabetes. It has only been studied in children with type 2 diabetes who weigh 50 kg or more, and have overweight or obesity when starting treatment.
This medicine should not be given to children under 10 years of age treated for type 2 diabetes and to children and adolescents under 18 years of age for weight management because it has not been studied in these age groups.
Other medicines and Mounjaro
Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines.
Pregnancy
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.
Breast-feeding
Tirzepatide passes into breast milk in very low amounts and is not expected to be absorbed by a breastfed newborn/infant. If you are breast-feeding or are planning to breast-feed, talk to your doctor before using or continuing to use this medicine.
Driving and using machines
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.
Mounjaro contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.
3. How to use Mounjaro
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure how to use this medicine.
How much to use
Each vial contains one dose of Mounjaro either 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg.
Adults
- 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.
Adolescents and children aged 10 to less than 18 years of age treated for type 2 diabetes
- 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, and 10 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.
Choosing when to give Mounjaro
You can use Mounjaro 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 mark on a calendar the day of the week when you inject your first dose.
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
If you are injecting this medicine yourself, you will be shown how to prepare and inject the medicine by your doctor, pharmacist or nurse. Do not inject this medicine yourself unless you have received training and you understand the procedure.
Always use Mounjaro exactly as your doctor has told you. Before you begin using Mounjaro, always read the “Instructions for Use” below carefully, and talk to your doctor, pharmacist or nurse if you are not sure about how to inject Mounjaro correctly.
If you experience any issues with self-administration, seek medical attention.
Mounjaro is injected under the skin (subcutaneous injection) of your stomach area (abdomen) or upper leg (thigh) or the back of your upper arm. Someone else should help if you want to inject in the back of 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” below carefully before using Mounjaro. If you are below 18 years of age, a caregiver may give you your Mounjaro injection or you may self-inject if your doctor determines that it is appropriate.
Step 1 First wash your hands with soap and water.
Step 2 Check that the Mounjaro in the vial looks clear and colourless to slightly yellow. Do not use if it is frozen, cloudy, or has particles in it.
Step 3 Pull off the vial plastic protective cap,
but do not remove the stopper.
Step 4 Clean the stopper on the vial with a swab.
Step 5 Prepare a new syringe and needle.
Use a suitable syringe that has a marking of 0.5ml.
It is recommended to use a 29 to 33 Gauge needle, with a length of 4 to 8mm.
Do not share or reuse your needle or syringe.
Step 6 Hold the syringe in one hand with the needle pointing up. With the other hand pull down on the plunger until the plunger tip reaches the line on the syringe indicating that 0.5 mL of air has been drawn into the syringe.
Step 7
Put the needle
through the
rubber stopper
on top of the
Mounjaro vial.
Step 8 Inject all the air
into the vial.
Step 9
Turn the Mounjaro vial and the syringe upside down, making sure the tip of the needle is in the solution. Slowly pull the syringe plunger down to withdraw 0.5 ml of Mounjaro solution from the vial. The vial is filled to enable delivery of a single 0.5 ml dose of Mounjaro.
If there are air bubbles in the syringe, tap the syringe gently a few times to let any air bubbles rise to the top. Slowly push the plunger up until there is no more air in the syringe.
Step 10 Once you have 0.5 ml solution in the syringe with no air bubbles,
pull the syringe out of the vial stopper.
Step 11 Choose your injection site. Mounjaro can be injected under
the skin (subcutaneously) of your stomach area (abdomen) or thighs, and with the help of someone else, in the back of the upper arm.
Ensure the area of skin you wish to inject into is clean. If it is not, clean with soap and water and allow to dry.
Change (rotate) your injection site within the area you choose for each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.
Do not inject where the skin has pits,
is thickened, or has lumps.
- Do not mix Mounjaro with any other medicine.
Do not inject where the skin is tender,
bruised, scaly or hard, or into scars or
damaged skin.
- Do not inject Mounjaro in the same injection site used for other medicines.
Step 12 Gently pinch and hold a fold of skin where you will inject
between your thumb and forefinger.
The lifted skin fold should not be squeezed so tightly that it causes pain or skin blanching (when skin goes white or pale when pressed).
Step 13 Insert the
needle into
your skin.
Step 14 Inject under the skin, as you have been
instructed. Inject all the solution from
the syringe to receive a full dose. After your injection, the needle should stay under
your skin for
5 seconds to make
sure you receive the full dose.
Step 15 Pull the needle out of your skin. Release the skin fold, if you see blood after you take the needle out of your skin, press the injection site with a piece of gauze. Do not rub the area.
Step 16 Throw away the vial, used needle and syringe immediately after each injection in a puncture resistant container, or as instructed by your doctor, pharmacist or nurse.
Testing blood glucose levels
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
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 use Mounjaro
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.
If you stop using Mounjaro
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.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
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)
- Inflamed pancreas (acute pancreatitis) which could cause severe pain in the stomach and back which does not go away. This is a serious, potentially life-threatening condition. You should see a doctor immediately if you experience such symptoms.
Stop using this medicine and seek urgent medical help if you experience:
Severe, persistent pain in the stomach area (abdomen), with or without nausea and vomiting.
This could be a sign of acute pancreatitis, which is serious and potentially life-threatening.
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.
Other side effects
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 time1*
- Stomach (abdominal) pain1
- Constipation2
- Feeling tired (fatigue)3
- Feeling less hungry (decreased appetite)4.
*These side effects are usually not severe. They are most common when first starting tirzepatide but decrease over time in most patients.
1Abdominal pain and vomiting are very common in patients treated for weight management, and in the type 2 diabetes cardiovascular disease study. Abdominal pain and vomiting are very common in adolescents and children treated for type 2 diabetes but are common in adults treated for type 2 diabetes.
2Constipation is very common in patients treated for weight management, and in the type 2 diabetes cardiovascular disease study but common in patients treated for type 2 diabetes. 3Fatigue was very common in the type 2 diabetes cardiovascular disease study and common in patients treated for weight management, and type 2 diabetes.
4Decreased appetite was very common in the type 2 diabetes cardiovascular disease study, and common in patients treated for type 2 diabetes.
Common (may affect up to 1 in 10 people)
- Low blood sugar (hypoglycaemia) when tirzepatide is used in adults for type 2 diabetes with both metformin and a sodium-glucose co-transporter 2 inhibitor (another diabetes medicine). Low blood sugar (hypoglycaemia) when tirzepatide is used with metformin alone in adolescents and children 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.
- 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
- 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
- Injection site reactions (e.g. itching or redness)
- Fast pulse1
- Increased levels of pancreatic enzymes (such as lipase and amylase2) in blood
- Increased calcitonin levels in blood3
- Gallstones4
- Cholecystitis (infection of the gallbladder) observed in patients treated for weight management5.
1Fast pulse are common side effects when used for type 2 diabetes and uncommon when used for weight management. It was also uncommon in the type 2 diabetes cardiovascular disease study. 2Increased levels of amylase are common side effects when used for type 2 diabetes and uncommon when used for weight management.
3Increased calcitonin levels in blood are common when used for weight management, but uncommon when used for type 2 diabetes.
4Increased gallstones were common in the cardiovascular disease study and when used for weight management but uncommon when used in adults for type 2 diabetes.
5Cholecystitis was common in the type 2 diabetes cardiovascular disease study and uncommon in patients treated for weight management.
Uncommon (may affect up to 1 in 100 people)
Low blood sugar (hypoglycaemia) when tirzepatide is used with metformin in adults 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.
- Weight loss observed in patients treated for type 2 diabetes
- Injection site pain
- Changed sense of taste
- Change in skin sensation
- A delay in the emptying of the stomach.
Reporting of side effects
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.
5. How to store 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 refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C). Do not freeze. If the vial has been frozen, DO NOT USE.
Store in the original packaging in order to protect from light.
Mounjaro can be stored unrefrigerated not above 30 ºC for up to 21 cumulative days and then the vial must be discarded.
Do not use this medicine if you notice that the 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.
6. Contents of the pack and other information
What Mounjaro contains
The active substance is tirzepatide.
- Mounjaro 2.5 mg: Each vial contains 2.5 mg of tirzepatide in 0.5 ml solution.
- Mounjaro 5 mg: Each vial contains 5 mg of tirzepatide in 0.5 ml solution.
- Mounjaro 7.5 mg: Each vial contains 7.5 mg of tirzepatide in 0.5 ml solution.
- Mounjaro 10 mg: Each vial contains 10 mg of tirzepatide in 0.5 ml solution.
- Mounjaro 12.5 mg: Each vial contains 12.5 mg of tirzepatide in 0.5 ml solution.
- Mounjaro 15 mg: Each vial contains 15 mg of tirzepatide in 0.5 ml solution.
The other ingredients are sodium phosphate dibasic heptahydrate, sodium chloride, sodium hydroxide (see section 2 under ‘Mounjaro contains sodium’ for further information); concentrated hydrochloric acid and water for injections.
What Mounjaro looks like and contents of the pack
Mounjaro is a clear, colourless to slightly yellow, solution for injection in a vial. The vial is for single use only.
Pack contains one vial.
Needles and syringe are not provided in this pack.
Marketing Authorisation Holder
Eli Lilly Nederland B.V., Orteliuslaan 1000, 3528 BD Utrecht, The Netherlands
Manufacturer
Eli Lilly Italia S.p.A.,Via Gramsci 731/733, 50019, Sesto Fiorentino, Firenze (FI), Italy
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
United Kingdom
Eli Lilly and Company Limited
Tel: + 44-(0) 1256 315000