Mounjaro (Tirzepatide)

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

Mounjaro is 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.

Mounjaro used together with a reduced-calorie and increased physical activity for weight loss and to help keep the weight under control in adults, who have:

• A BMI of 30kg/m2 or greater or
• A BMI of at least 27kg/m2 but less than 30kg/m2 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)

Do not use Mounjaro KwikPen

• If you are allergic to tirzepatide or any of the other ingredients of this medicine.

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.

• You have ever had pancreatitis

• You have a problem with your eyes

• You are using sulphonylurea or insulin for your diabetes, as low blood sugar 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.

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 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

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 can your doctor should decide if you should stop breast-feeding or delay using Mounjaro.

Driving and using machines

It is unlikely 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 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, feast heartbeat and sweating.

Mounjaro KwikPen contains sodium

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

Mounjaro KwikPen contains benzyl alcohol

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

Ask your doctor or pharmacist for advice if you have 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”).