1. What Mounjaro is and what it is used for
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 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.
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).
- 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
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.
Other medicines and Mounjaro
Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines.
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. This medicine should not be used during pregnancy as the effects of this medicine on an unborn child are not known. Therefore, it is recommended to use contraception while using this medicine.
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.
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
- 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.
Choosing when to give Mounjaro
Each pen contains one dose of Mounjaro either 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg.
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 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
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.
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’).
Read the “Instructions for Use” for the pen carefully before using Mounjaro.
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, 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. You should see a doctor immediately if you experience such symptoms.
Other side effects
Very common (may affect more than 1 in 10 people)
- Feeling sick (nausea)
These side effects are usually not severe. They are most common when first starting tirzepatide but decrease over time in most patients.
- Low blood sugar (hypoglycaemia) is very common when tirzepatide is used 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.
Common (may affect up to 1 in 10 people)
- Low blood sugar (hypoglycaemia) is common when tirzepatide is used with both metformin and a sodium-glucose co-transporter 2 inhibitor (another diabetes medicine)
- Allergic reaction (hypersensitivity) (e.g., rash, itching, and eczema)
- Feeling less hungry (decreased appetite)
- Stomach (abdominal) pain
- Being sick (vomiting) – this usually goes away over time
- Indigestion (dyspepsia)
- Bloating of the stomach
- Burping (eructation)
- Gas (flatulence)
- Reflux or heartburn (also called gastroesophageal reflux disease – GERD) – a disease caused by stomach acid coming up into the tube from your stomach to your mouth
- Feeling tired (fatigue)
- Injection site reactions (e.g. itching or redness)
- Fast pulse
- Increased levels of pancreatic enzymes (such as lipase and amylase) in blood.
Uncommon (may affect up to 1 in 100 people)
- Low blood sugar (hypoglycaemia) is uncommon when tirzepatide is used with metformin.
- Weight loss
- Increased calcitonin levels in blood.
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 pen 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 pen 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 °C for up to 21 cumulative days and then the pen must be discarded.
Do not use this medicine if you notice that the pen 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.