DESCRIPTION

Product details & mandatory information
Prescription drug

Active ingredients

30 mg tirzepatide
Excipients
21.6 mg benzyl alcohol
Water for injections
Sodium hydroxide for pH adjustment
Hydrochloric acid for pH adjustment
Sodium chloride
Disodium hydrogen phosphate-7-water
Phenol
Glycerol

This medicine contains the active substance tirzepatide and is used to treat adults with type 2 diabetes mellitus. It lowers the level of sugar in the body only when the sugar level is high.
The medicine is also used to treat adults who are obese or overweight (with a BMI of at least 27 kg/m2). It affects appetite regulation, which can help you eat less food and reduce your body weight.
In type 2 diabetes, the medicine is used:
on its own when you cannot take metformin (another medicine for treating diabetes).
with other medicines for treating diabetes when they do not control your blood sugar sufficiently. These other medicines may be medicines you take and/or an insulin that is injected.
The medicine is also used together with diet and exercise for weight reduction and weight management in adults who:
have a BMI of 30 kg/m2 or more (obesity) or
have a BMI of at least 27 kg/m2 but less than 30 kg/m2 (overweight) and have weight-related health problems (such as prediabetes, type 2 diabetes, high blood pressure, abnormal blood fat levels, 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 that you continue to follow your doctor, nurse or pharmacist’s advice on diet and exercise.

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure
Dosage
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 in 2.5 mg increments to 7.5 mg, 10 mg, 12.5 mg or 15 mg once a week if needed. In each case, your doctor will instruct you to stay at a certain dose for at least 4 weeks before moving on to a higher dose.
Do not change your dose unless your doctor tells you to.
Each vial contains one dose of the medicine, either 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg or 15 mg.
Checking your blood sugar levels
If you are using this medicine with a sulphonylurea or insulin, it is important that you check your blood sugar levels as directed by your doctor, nurse or pharmacist.

If you use more than you should
If you use more than you should, talk to your doctor straight away. Too much of this medicine may make you have low blood sugar (hypoglycaemia), nausea or vomiting.

If you forget to use it
If you forget to inject a dose and
it has been 4 days or less since you should have used the medicine, inject 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 the medicine, 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 time between two applications must be at least 3 days.

If you stop using it
Do not stop using Mounjaro without talking to your doctor first. If you stop using it and you have type 2 diabetes, your blood sugar may increase.

If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.

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)
Inflammation of the pancreas (acute pancreatitis), which may cause severe abdominal and back pain that does not go away. You should see a doctor immediately if you notice any of these symptoms.
Rare (may affect up to 1 in 1,000 people)
Serious allergic reactions (e.g. anaphylactic reaction, angioedema). You should get medical help immediately and tell your doctor if you notice symptoms such as difficulty breathing, sudden swelling of the lips, tongue and/or throat with difficulty swallowing and fast heartbeat.
Other side effects
Very common (may affect more than 1 in 10 people)
Nausea
Diarrhoea
These side effects are not usually serious. They are most common when you first start taking tirzepatide, but they decrease over time in most patients.
Low blood sugar (hypoglycaemia) is very common when tirzepatide is used with medicines containing a sulphonylurea and/or insulin. If you are taking a sulphonylurea or insulin for type 2 diabetes, your dose may need to be reduced while you are using tirzepatide. 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) occurs when tirzepatide is used in combination with metformin and a sodium-glucose co-transporter 2 inhibitor (SGLT2 inhibitor) for type 2 diabetes (another diabetes medicine).
Allergic reactions (hypersensitivity) (e.g. rash, itching and eczema)
Dizziness has been reported in patients treated for weight management.
Low blood pressure has been reported in patients treated for weight management.
Feeling less hungry (reduced appetite) has been reported in patients treated for type 2 diabetes.
Stomach (abdominal) pain
Vomiting – this usually goes away with time
Indigestion (dyspepsia)
Constipation
Swollen abdomen
Burping (belching)
Flatulence
Reflux or heartburn (also called gastroesophageal reflux disease – GERD) – a condition caused by stomach acid moving from the stomach into the oesophagus
Hair loss has been reported in patients treated for weight management.
Fatigue (weakness)
Injection site reactions (e.g. itching or redness)
Fast heart rate
Increased levels of pancreatic enzymes (such as lipase and amylase) in the blood
Uncommon (may affect up to 1 in 100 people)
Low blood sugar (hypoglycaemia) occurs when tirzepatide is used in combination with metformin for type 2 diabetes.
Gallstones
Inflammation of the gallbladder
Weight loss has been reported in patients treated for type 2 diabetes.
Pain at the injection site
Increased levels of calcitonin in the blood
If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any side effects not listed.

Warnings and precautions
Please talk to your doctor, nurse or pharmacist before using this medicine if
you have serious problems digesting food or food stays in your stomach longer than normal (including severe gastroparesis).
you have ever had pancreatitis (an inflammation of the pancreas which can cause severe abdominal and back pain which does not go away).
you have problems with your eyes (diabetic retinopathy or macular oedema).
you are using sulphonylurea preparations (another diabetes medicine) or insulin to treat your diabetes, as low blood sugar (hypoglycaemia) may occur. Your doctor may order a dose change of these other medicines to reduce this risk.
When you start taking this medicine, in some cases you may experience fluid loss/dehydration, e.g. due to vomiting, nausea and/or diarrhoea, which may lead to impaired kidney function. It is important to avoid dehydration by drinking plenty of fluids. Ask your doctor if you have any questions or concerns.
Children and adolescents
This medicine must not be given to children and adolescents under 18 years of age because it has not been studied in this age group.

Driving and using machines
This medicine is unlikely to affect your ability to drive or use machines. However, if you use the medicine 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 experience any signs of low blood sugar, such as headache, drowsiness, weakness, dizziness, feeling hungry, confusion, irritability, fast heartbeat and sweating. See the Patient Information section for information on an increased risk of low blood sugar. Speak to your doctor for more information.

Pregnancy
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 because the effects of this medicine on an unborn child are not known. Therefore, it is recommended that you use contraception while using this medicine.
Breastfeeding
It is not known whether tirzepatide passes into breast milk. A risk to newborns/infants cannot be excluded. If you are breast-feeding or intend to breast-feed, talk to your doctor before using this medicine. You and your doctor should decide whether you should stop breast-feeding or delay using the preparation.

Choosing when to use the medicine
You can use the medicine at any time of the day, regardless of meals. If possible, you should always use it on the same day of the week. To help you remember when to use the medicine, you can mark the day of the week on which you inject your first dose on a calendar.
If necessary, you can change the day of the week of your weekly injection, provided that at least 3 days have passed since your last injection. After you have chosen a new day for the injection, continue with the once-weekly dosing on that new day of the week.
How to use the medicine
Always use the medicine exactly as your doctor has told you. Read the package leaflet carefully before using it and talk to your doctor, nurse or pharmacist if you are not sure how to inject the medicine correctly.
The medicine is injected under the skin (subcutaneous injection) of your stomach area (abdomen), thigh or upper arm. You may need help from another person if you want to inject into your upper arm. Do not inject directly into a vein as this will change the way it works.
If you want, you can inject into the same area of ​​the body each week, but make sure you choose a different injection site within that area. If you also inject insulin, choose a different injection site for this injection. If you are blind or visually impaired, you will need someone to help you give your injection.
How to use
1. Wash your hands with soap and water first.
2. Check that the medicine in the vial looks clear and colourless to slightly yellow. Do not use it if it is frozen, cloudy or has particles in it.
3. Remove the protective plastic cap from the vial, but do not remove the stopper. Clean the stopper on the vial with a swab and prepare a new syringe. Do not share or reuse your needle or syringe.
4. Draw a small amount of air into the syringe. Insert the needle through the rubber stopper on the vial and inject the air into the vial.
5. Turn the vial and syringe upside down and slowly pull the syringe plunger down to withdraw all the solution from the vial. The vial is filled to deliver a single 0.5 ml dose of medicine.
6. If there are air bubbles in the syringe, gently tap the syringe a few times to allow the air bubbles to rise to the top. Gently push the syringe plunger up until there is no air left in the syringe.
7. Remove the syringe from the vial stopper.
8. Clean your skin before injecting.
9. Gently pinch the skin and hold a fold of skin where you want to inject.
10. Inject under the skin as you have been shown. Inject all of the solution from the syringe to get the full dose. The needle should remain in the skin for 5 seconds after the injection to make sure you get the full dose.
11. Remove the needle from your skin.
12. Immediately after each injection, dispose of the vial, used needle and syringe in a puncture-resistant container or as directed by your doctor, nurse or pharmacist.

Use with other medicines
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines.

Mounjaro Tirzepatide 7.5mg Injection

Mounjaro (tirzepatide) 7.5mg Injection is a prescription medication that is used along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes mellitus. It is a once-weekly injection that helps the body produce more insulin and use insulin more effectively. Mounjaro is not for everyone. Talk to your doctor to see if it is right for you.

Some side effects of Mounjaro Tirzepatide 7.5mg Injection may include:

• Nausea
• Diarrhea
• Vomiting
• Constipation
• Headache
• Fatigue
• Dizziness
• Hypoglycemia (low blood sugar)
• Weight loss

If you experience any of these side effects, talk to your doctor.

Mounjaro is not for everyone. Do not use Mounjaro if you have:

• A history of pancreatitis
• Type 1 diabetes
• A serious allergic reaction to tirzepatide or any of the ingredients in Mounjaro

Before you start using Mounjaro, talk to your doctor about your medical history, including any other medications you are taking.

To learn more about Mounjaro, talk to your doctor or visit the Mounjaro website.

Here are some additional information about Mounjaro Tirzepatide 7.5mg Injection:

• It is a clear, colorless to slightly yellow, sterile, preservative-free solution for subcutaneous use.
• Each single-dose pen contains a 0.5 mL solution of 7.5 mg of tirzepatide and the following excipients: sodium chloride (4.1 mg), sodium phosphate dibasic heptahydrate (0.7 mg), and water for injection.
• It is stored at room temperature up to 86 degrees Fahrenheit (30 degrees Celsius) for up to 21 days.
• It is not known if Mounjaro is safe and effective for use in pregnant or breastfeeding women.

If you have any questions or concerns about Mounjaro, talk to your doctor.