Mounjaro 2.5 mg/dose KwikPen solution for injection in pre-filled pen
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Mounjaro 2.5 mg/dose KwikPen injectable solution in a pre-filled pen
Mounjaro 5 mg/dose KwikPen injectable solution in a pre-filled pen
Mounjaro 7.5 mg/dose KwikPen injectable solution in a pre-filled pen
Mounjaro 10 mg/dose KwikPen injectable solution in a pre-filled pen
Mounjaro 12.5 mg/dose KwikPen injectable solution in a pre-filled pen
Mounjaro 15 mg/dose KwikPen injectable solution in a pre-filled pen
tirzepatide
This medicinal product is subject to additional monitoring, which will allow for faster identification of new safety information. You can help by reporting any adverse reactions you may experience. Section 4 includes information on how to report adverse reactions.
Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor, nurse, or pharmacist.
- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, as it may harm them.
- If you experience any adverse reactions, consult your doctor, nurse, or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Contents of the leaflet
- What Mounjaro KwikPen is and what it is used for
- What you need to know before using Mounjaro KwikPen
- How to use Mounjaro KwikPen
- Possible adverse reactions
- Storage of Mounjaro KwikPen
- Contents of the pack and other information
1. What Mounjaro is and what it is used for
Mounjaro contains an active substance called tirzepatide and is used to treat adults, adolescents, and children aged 10 years and older with type 2 diabetes mellitus. Mounjaro lowers the level of sugar in the body only when sugar levels are high.
Mounjaro is also used to treat adults with obesity or overweight (with a BMI of at least 27 kg/m²). Mounjaro influences the regulation of appetite, which may help you eat less food and reduce your body weight.
In type 2 diabetes, Mounjaro is used:
- on its own when you cannot take metformin (another diabetes medicine).
- or in combination with other diabetes medicines when these are not sufficient to control your blood sugar levels. These other medicines may be taken orally and/or may be insulin injections.
Mounjaro is also used together with diet and exercise to lose weight and help keep weight under control in adults who have:
- a BMI equal to or greater than 30 kg/m² (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 blood fat levels, breathing problems during sleep known as "obstructive sleep apnoea", heart failure, or history of heart attack, stroke, or vascular problems).
BMI (Body Mass Index) is a measure of your weight in relation to your height.
In patients with obstructive sleep apnoea (OSA) and obesity, Mounjaro can be used with or without positive airway pressure (PAP) treatment.
It is important that you follow the advice on diet and physical activity provided by your doctor, nurse, or pharmacist.
2. What you need to know before using Mounjaro KwikPen
Do not use Mounjaro KwikPen
- if you are allergic to tirzepatide or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, nurse, or pharmacist before starting to use Mounjaro if:
- you have severe problems with food digestion or food stays in your stomach longer than normal (including severe gastroparesis).
- you have ever had pancreatitis (inflammation of the pancreas, which may cause severe stomach and back pain that does not go away).
- you have any eye problems (diabetic retinopathy or macular edema).
- you are taking a sulfonylurea (another diabetes medicine) or insulin for diabetes, as low blood sugar (hypoglycemia) may occur. Your doctor may need to adjust the dose of these medicines to reduce this risk.
At the beginning of treatment with Mounjaro, you may in some cases experience fluid loss/dehydration due to vomiting, nausea and/or diarrhea, which could lead to reduced kidney function. To prevent dehydration, it is important to drink plenty of fluids. Contact your doctor if you have any questions or concerns.
If you know you are going to undergo surgery under anesthesia (a state of sleep), inform your doctor that you are taking Mounjaro.
Children and adolescents
This medicine can be used in children from 10 years of age for the treatment of type 2 diabetes. It has only been studied in children with type 2 diabetes who had overweight or obesity at the start of treatment.
This medicine must not be given to children under 10 years of age being treated for type 2 diabetes, or to adolescents under 18 years of age for weight control, as it has not been studied in these age groups.
Other medicines and Mounjaro
Tell your doctor, nurse, or pharmacist if you are using, have recently used, or might need to use any other medicines.
Pregnancy
If you are pregnant, think you might be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. This medicine should not be used during pregnancy as the effects of this medicine on the unborn baby are unknown. Therefore, it is recommended to use contraception while taking this medicine.
Breast-feeding
Tirzepatide passes into breast milk in very low amounts and is not expected to be absorbed by a newborn/infant. If you are breast-feeding or planning to breast-feed, consult 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 or use machines. However, if you use Mounjaro in combination with a sulfonylurea or insulin, low blood sugar (hypoglycemia) may occur, which could impair your concentration. Avoid driving or using machines if you experience any signs of low blood sugar, such as headache, drowsiness, weakness, dizziness, hunger, confusion, irritability, rapid heartbeat, or sweating (see section 4). See section 2, “Warnings and precautions” for information on increased risk of low blood sugar. Consult your doctor for more information.
Mounjaro KwikPen contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is essentially “sodium-free”.
Mounjaro KwikPen contains benzyl alcohol
This medicine contains 5.4 mg of benzyl alcohol in each 0.6 ml dose. Benzyl alcohol may cause allergic reactions.
Consult your doctor, nurse, or pharmacist if you are pregnant or breast-feeding, or if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and cause side effects (a condition known as "metabolic acidosis").
3. How to use Mounjaro KwikPen
Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
A small amount of medicine may remain in the pen after correctly administering all doses. Do not attempt to use the leftover medicine. After administering four doses, the pen must be properly discarded.
How much to use
Adults
- The initial 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 remain on a specific dose for at least 4 weeks before moving to a higher dose.
Adolescents and children aged 10 to less than 18 years old being treated for type 2 diabetes
- The initial dose is 2.5 mg once a week for four weeks. After four weeks, your doctor will increase the dose to 5 mg once a week.
- Your doctor may increase the dose in 2.5 mg increments to 7.5 mg and then to 10 mg once a week, if needed. In each case, your doctor will instruct you to remain on a specific dose for at least 4 weeks before moving to a higher dose.
Do not change your dose unless your doctor has instructed you to do so.
Choosing when to use Mounjaro
You may use your pen at any time of day, with or without food. If possible, you should use it on the same day each week. To help you remember when to use Mounjaro, you may wish to mark it on a calendar.
If necessary, you may change the day of your weekly Mounjaro injection, provided at least 3 days have passed since your last injection. After selecting a new dosing day, continue administering once a week on that new day.
How to inject Mounjaro KwikPen
Mounjaro is injected under the skin (subcutaneous injection) into the abdominal area at least 5 cm away from the navel, or into the upper leg (thigh), or into the back of the upper arm. If you choose to inject into the back of the upper arm, another person should assist you.
If you wish, you may inject into the same body area each week. However, in this case, make sure to select different injection sites within the same area. If you also inject insulin, choose a different injection site for that injection.
Before using Mounjaro KwikPen, carefully read the “Instructions for Use” provided with the pen. If you are under 18 years of age, a caregiver may administer the Mounjaro injection for you, or you may self-inject if your doctor considers it appropriate.
Monitoring blood glucose levels
If you are using Mounjaro with a sulfonylurea or insulin, it is important to monitor your blood glucose levels as instructed by your doctor, nurse, or pharmacist (see section 2, “Warnings and precautions”).
If you use more Mounjaro than you should
If you use more Mounjaro than you should, contact your doctor immediately. Too much medicine may cause your blood sugar to drop too low (hypoglycemia) and may also cause nausea or vomiting.
If you forget to use Mounjaro
If you forget to inject a dose and:
- 4 days or fewer have passed 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 more than 4 days have passed since you should have used Mounjaro, skip the missed dose. Then inject your next dose as usual on your scheduled day.
Do not inject a double dose to make up for a missed dose. The minimum time between two doses must be at least 3 days.
If you stop using Mounjaro
Do not stop using Mounjaro without consulting your doctor. If you stop treatment with Mounjaro and have type 2 diabetes, your blood sugar levels may increase.
If you have any further questions about the use of this medicine, ask your doctor, nurse, or pharmacist.
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)
- Inflammation of the pancreas (acute pancreatitis), which could cause severe stomach and back pain that does not go away. Seek immediate medical attention if you experience these symptoms.
Rare (may affect up to 1 in 1,000 people)
- Serious allergic reactions (e.g., anaphylactic reaction, angioedema). You must seek immediate medical help and inform your doctor if you experience symptoms such as breathing difficulties, rapid swelling of the lips, tongue and/or throat with difficulty swallowing, and rapid heartbeat.
Other side effects
Very common (may affect more than 1 in 10 people)
- Nausea
- Diarrhea
- Stomach (abdominal) pain reported in patients treated for weight control and in adolescents and children treated for type 2 diabetes
- Nausea (vomiting) reported in patients treated for weight control and in adolescents and children treated for type 2 diabetes
- Constipation reported in patients treated for weight control
These side effects are usually not serious. Nausea, diarrhea, and vomiting are more common when starting tirzepatide, but decrease over time in most patients.
- Low blood sugar (hypoglycemia) is very common when tirzepatide is used together with other medicines containing a sulfonylurea and/or insulin. If you are taking a sulfonylurea or insulin for type 2 diabetes, your dose may need to be reduced while using tirzepatide (see section 2, “Warnings and precautions”). Symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, feeling hungry, confusion, irritability, rapid heartbeat, and sweating. Your doctor should advise you on how to treat low blood sugar levels.
Common (may affect up to 1 in 10 people)
- Low blood sugar (hypoglycemia) when tirzepatide is used for type 2 diabetes with metformin together with a sodium-glucose cotransporter-2 inhibitor (another diabetes medicine)
- Low blood sugar (hypoglycemia) when tirzepatide is used together with metformin alone in adolescents and children for type 2 diabetes
- Allergic reaction (hypersensitivity) (e.g., rash, itching, and eczema)
- Dizziness reported in patients treated for weight control
- Low blood pressure reported in patients treated for weight control
- Reduced appetite (decreased appetite) reported in patients treated for type 2 diabetes
- Stomach (abdominal) pain reported in adult patients treated for type 2 diabetes
- Vomiting reported in adult patients treated for type 2 diabetes – usually decreases over time
- Indigestion (dyspepsia)
- Constipation reported in patients treated for type 2 diabetes
- Stomach swelling
- Belching
- Gas (flatulence)
- Reflux or heartburn (also known as gastroesophageal reflux disease – GERD) – a condition caused by stomach acid rising into the tube connecting the stomach to the mouth
- Hair loss reported in patients treated for weight control
- Tiredness (fatigue)
- Injection site reactions (e.g., itching or redness)
- Rapid pulse
- Increased levels of pancreatic enzymes (such as lipase and amylase) in blood
- Increased levels of calcitonin in blood in patients treated for weight control
Uncommon (may affect up to 1 in 100 people)
- Low blood sugar (hypoglycemia) when tirzepatide is used with metformin in adults for type 2 diabetes
- Gallstones
- Inflammation of the gallbladder
- Weight loss reported in patients treated for type 2 diabetes
- Pain at the injection site
- Increased levels of calcitonin in blood in adult patients treated for type 2 diabetes or for obesity with AOS
- Altered sense of taste
- Change in skin sensitivity
- Delayed stomach emptying
Reporting of side effects
If you experience any side effect, talk to your doctor, nurse, or pharmacist, including any possible side effects not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Mounjaro KwikPen
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pen label and packaging after EXP. The expiry date refers to the last day of the month indicated.
Store in a refrigerator (between 2 ºC and 8 ºC). Do not freeze. If the pen has been frozen, DO NOT USE IT.
Mounjaro KwikPen may be stored unrefrigerated below 30 ºC for up to 30 days after first use, after which the pen must be discarded.
Do not use this medicine if you notice that the pen is damaged or if the solution is cloudy, discolored, or contains particles.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging once they are no longer needed. This helps protect the environment.
6. Contents of the pack and other information
Composition of Mounjaro KwikPen
The active substance is tirzepatide.
Mounjaro 2.5 mg/dose KwikPen: Each dose contains 2.5 mg of tirzepatide in 0.6 ml of solution. Each multidose pre-filled pen contains 10 mg of tirzepatide in 2.4 ml (4.17 mg/ml). Each pen delivers 4 doses of 2.5 mg.
Mounjaro 5 mg/dose KwikPen: Each dose contains 5 mg of tirzepatide in 0.6 ml of solution. Each multidose pre-filled pen contains 20 mg of tirzepatide in 2.4 ml (8.33 mg/ml). Each pen delivers 4 doses of 5 mg.
Mounjaro 7.5 mg/dose KwikPen: Each dose contains 7.5 mg of tirzepatide in 0.6 ml of solution. Each multidose pre-filled pen contains 30 mg of tirzepatide in 2.4 ml (12.5 mg/ml). Each pen delivers 4 doses of 7.5 mg.
Mounjaro 10 mg/dose KwikPen: Each dose contains 10 mg of tirzepatide in 0.6 ml of solution. Each multidose pre-filled pen contains 40 mg of tirzepatide in 2.4 ml (16.7 mg/ml). Each pen delivers 4 doses of 10 mg.
Mounjaro 12.5 mg/dose KwikPen: Each dose contains 12.5 mg of tirzepatide in 0.6 ml of solution. Each multidose pre-filled pen contains 50 mg of tirzepatide in 2.4 ml (20.8 mg/ml). Each pen delivers 4 doses of 12.5 mg.
Mounjaro 15 mg/dose KwikPen: Each dose contains 15 mg of tirzepatide in 0.6 ml of solution. Each multidose pre-filled pen contains 60 mg of tirzepatide in 2.4 ml (25 mg/ml). Each pen delivers 4 doses of 15 mg.
The other components are disodium hydrogen phosphate heptahydrate (E339), benzyl alcohol (E1519) (see section 2 “Mounjaro KwikPen contains benzyl alcohol” for more information), glycerol, phenol, sodium chloride and sodium hydroxide (see section 2 “Mounjaro contains sodium” for more information); concentrated hydrochloric acid and water for injections.
Nature and contents of the container
Mounjaro is a clear, colourless to slightly yellowish injectable solution in a pre-filled pen (KwikPen).
Each KwikPen contains 2.4 ml of injectable solution (4 doses of 0.6 ml) with excess for priming.
Needles are not included.
Pack sizes of 1 and 3 KwikPens.
Only some pack sizes may be marketed.
Marketing Authorization Holder
Eli Lilly Nederland B.V., Orteliuslaan 1000, 3528 BD Utrecht, Netherlands.
Manufacturer
Eli Lilly Italia S.p.A., Via Gramsci 731/733, 50019, Sesto Fiorentino, Florence (FI), Italy
Lilly S.A., Avda. de la Industria, 30, 28108 Alcobendas, Madrid, Spain
Lilly France, 2, rue du Colonel Lilly, 67640 Fegersheim, France
Millmount Healthcare Limited, Block 7 City North Business Campus, Stamullen, K32 YD60, Ireland
Millmount Healthcare Limited, IDA Science And Technology Park, Mullagharlin, Dundalk, Co. Louth, A91 DET0, Ireland
For more information about this medicine, contact the local representative of the Marketing Authorization Holder:
Belgium/Belgium/Belgium Eli Lilly Benelux S.A./N.V. Tel/Tel: + 32-(0)2 548 84 84 | Lithuania Eli Lilly Lietuva Tel. +370 (5) 2649600 |
| Luxembourg/Luxembourg Eli Lilly Benelux S.A./N.V. Tél/Tel: + 32-(0)2 548 84 84 |
Czech Republic ELI LILLY CR, s.r.o. Tel: + 420 234 664 111 | Hungary Lilly Hungária Kft. Tel: + 36 1 328 5100 |
Denmark Eli Lilly Danmark A/S Tlf.: +45 45 26 60 00 | Malta Charles de Giorgio Ltd. Tel: + 356 25600 500 |
Germany Lilly Deutschland GmbH Tel. + 49-(0) 6172 273 2222 | Netherlands Eli Lilly Nederland B.V. Tel: + 31-(0) 30 60 25 800 |
Estonia Eli Lilly Nederland B.V. Tel: +372 6 817 280 | Norway Eli Lilly Norge A.S. Tlf: + 47 22 88 18 00 |
Greece PHARMASERV-LILLY S.A. Tel: +30 210 629 4600 | Austria Eli Lilly Ges.m.b.H. Tel: + 43-(0) 1 20609 1270 |
Spain Lilly S.A. Tel: + 34-91 663 50 00 | Poland Eli Lilly Polska Sp. z o.o. Tel: +48 22 440 33 00 |
France Lilly France Tél: +33-(0) 1 55 49 34 34 | Portugal Lilly Portugal Produtos Farmacêuticos, Lda Tel: + 351-21-4126600 |
Croatia Eli Lilly Hrvatska d.o.o. Tel: +385 1 2350 999 | Romania Eli Lilly România S.R.L. Tel: + 40 21 4023000 |
Ireland Eli Lilly and Company (Ireland) Limited Tel: + 353-(0) 1 661 4377 | Slovenia Eli Lilly farmacevtska družba, d.o.o. Tel: +386 (0)1 580 00 10 |
Iceland Icepharma hf. Sími + 354 540 8000 | Slovakia Eli Lilly Slovakia s.r.o. Tel: + 421 220 663 111 |
Italy Eli Lilly Italia S.p.A. Tel: + 39- 055 42571 | Finland Oy Eli Lilly Finland Ab Puh/Tel: + 358-(0) 9 85 45 250 |
Cyprus Phadisco Ltd Tel: +357 22 715000 | Sweden Eli Lilly Sweden AB Tel: + 46-(0) 8 7378800 |
Latvia Eli Lilly (Suisse) S.A. Representative Office Latvia Tel: +371 67364000 |
Date of the most recent review of this leaflet:
Other sources of information
Detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.euopa.eu, and on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (https://www.aemps.gob.es/).
Instructions for use Prefilled multidose pen Each pen contains 4 fixed doses, one dose administered weekly. | |
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tirzepatide These instructions for use contain information on how to inject Mounjaro KwikPen
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Important information you should know before injecting Mounjaro KwikPen.
Read these instructions for use and the package leaflet before starting to inject Mounjaro KwikPen and each time you receive a new pen. There may be new information. This information does not replace discussions with your doctor, nurse, or pharmacist about your medical condition or treatment.
Mounjaro KwikPen is a disposable, prefilled multi-dose pen. The pen contains 4 fixed doses, one dose administered weekly. Inject one single injection per week under the skin (subcutaneously).
After 4 doses, discard the pen, including any unused medication. The pen will prevent you from dialing a full dose after 4 weekly doses have been administered. Do not inject any leftover medicine. Do not transfer medicine from the pen into a syringe.
Do not share your Mounjaro KwikPen with other people, even if the pen needle has been changed. You may give others a serious infection or get a serious infection from them.
People who are blind or have vision problems should not use the pen without help from someone trained to use it.
Supplies needed to inject
- Mounjaro KwikPen
- KwikPen-compatible pen needle (If you are unsure which pen needle to use, consult your healthcare provider)
- Alcohol swab, gauze, or cotton ball
- Sharps disposal container or household container
Preparing to inject Mounjaro KwikPen
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Priming removes air from the cartridge and ensures proper pen function. The pen is properly primed if a small amount of medication appears at the needle tip.
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Mounjaro KwikPen Injection
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If you see the icon in the window, this means you have received the full dose. If you do not see the icon in the dose window, reinsert the needle into the skin and complete the injection. Do not redose. If you still believe you did not receive the full dose, do not start again or repeat the injection. For more information, refer to the sections “Storage of your Mounjaro KwikPen” or “Frequently Asked Questions”. |
After your Mounjaro KwikPen injection
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Do not store the pen with the needle attached to prevent leakage, needle blockage, and air entering the pen. |
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Do not store the pen without the cap on. |
Storage of your Mounjaro KwikPen
Unused pens:
- Store unused pens in the refrigerator between 2°C and 8°C.
- Unused pens may be used until the expiration date printed on the label, provided the pen has been stored in the refrigerator.
- Do not freeze the pen. Discard the pen if it has been frozen.
Used pens:
- You may store your used pen at room temperature below 30°C after injection.
- Keep the pen and needles out of sight and reach of children.
- Discard the pen 30 days after first use, even if there is still medicine left in it.
- Discard the pen after receiving 4 weekly doses. If you attempt to inject the remaining medicine, the dose may be incomplete, even if there is still medicine in the pen.
Remaining medication:
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Disposal of Mounjaro KwikPen and pen needles
- Place used pen needles in a sharps disposal container or a hard plastic container with a secure lid.
- Do not throw (dispose of) loose pen needles into household trash.
- Dispose of the used pen according to instructions from your healthcare professional.
- Ask your healthcare professional about proper options for disposing of the sharps disposal container.
- Do not recycle your used sharps disposal container.
Frequently asked questions
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If you cannot remove the pen cap, gently twist it back and forth, then pull the cap off.
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If you cannot turn the dose button until the dose appears in the dose window:
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discard the pen, including any unused medicine. There may not be enough medicine left in the pen to deliver a full dose. Do not attempt to inject the remaining medicine.
If you have difficulty pressing the dose button:
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pressing the dose button more slowly may make it easier to administer the injection.
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your needle may be blocked. Attach a new needle and prime the pen.
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there may be dust, food, or liquid inside the pen. Discard the pen and get a new one.
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If you have any further questions or problems with Mounjaro KwikPen, contact Lilly or your doctor, nurse, or pharmacist.
Medical calendar
Use Mounjaro KwikPen 1 time a week. | I administer my weekly dose on the dates indicated below. | ||||
Write down the day of the week you wish to inject. Inject on that day every week (for example: Monday). | (Day/Month) | (Day/Month) | (Day/Month) | (Day/Month) | |
Last reviewed on