Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
Mounjaro is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise
For study results with respect to combinations, effects on glycaemic control and the populations studied, see sections 4.4, 4.5 and 5.1.
Mounjaro is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of
The starting dose of tirzepatide is 2.5 mg once weekly. After 4 weeks, the dose should be increased to 5 mg once weekly. If needed, dose increases can be made in 2.5 mg increments after a minimum of 4 weeks on the current dose.
The recommended maintenance doses are 5 mg, 10 mg and 15 mg.
The maximum dose is 15 mg once weekly.
When tirzepatide is added to existing metformin and/or sodium-glucose co-transporter 2 inhibitor (SGLT2i) therapy, the current dose of metformin and/or SGLT2i can be continued.
When tirzepatide is added to existing therapy of a sulphonylurea and/or insulin, a reduction in the dose of sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia. Blood glucose self-monitoring is necessary to adjust the dose of sulphonylurea and insulin. A stepwise approach to insulin reduction is recommended (see sections 4.4 and 4.8).
If a dose is missed, it should be administered as soon as possible within 4 days after the missed dose. If more than 4 days have passed, skip the missed dose and administer the next dose on the regularly scheduled day. In each case, patients can then resume their regular once weekly dosing schedule.
The day of weekly administration can be changed, if necessary, as long as the time between two doses is at least 3 days.
No dose adjustment is needed based on age, gender, race, ethnicity or body weight (see sections 5.1 and 5.2). Only very limited data are available from patients aged ≥85 years.
No dose adjustment is required for patients with renal impairment including end stage renal disease (ESRD). Experience with the use of tirzepatide in patients with severe renal impairment and ESRD is limited. Caution should be exercised when treating these patients with tirzepatide (see section 5.2).
No dose adjustment is required for patients with hepatic impairment. Experience with the use of tirzepatide in patients with severe hepatic impairment is limited. Caution should be exercised when treating these patients with tirzepatide (see section 5.2).
The safety and efficacy of tirzepatide in children aged less than 18 years have not yet been established. No data are available.
Mounjaro is to be injected subcutaneously in the abdomen, thigh or upper arm.
The dose can be administered at any time of day, with or without meals.
Injection sites should be rotated with each dose. If a patient also injects insulin, they should inject Mounjaro into a different injection site.
Patients should be advised to carefully read the instructions for use included with the package leaflet before administering the medicinal product.
Patients and their caregivers should be trained in subcutaneous injection technique before administering Mounjaro.
For further information before administration see section 6.6.
In the event of overdose, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms. Patients may experience gastrointestinal adverse reactions including nausea. There is no specific antidote for overdose of tirzepatide. A prolonged period of observation and treatment of these symptoms may be necessary, taking into account the half-life of tirzepatide (approximately 5 days).
Pre-filled pen, single-dose; vial, single-dose:
Before use
2 years.
Mounjaro may be stored unrefrigerated for up to 21 cumulative days at a temperature below 30ºC and then the pre-filled pen or vial must be discarded.
Pre-filled pen (KwikPen), multi-dose:
Before use
2 years.
After first use
30 days. Store unrefrigerated at room temperature below 30ºC. The pre-filled KwikPen must be discarded 30 days after first use.
Store in a refrigerator (2ºC–8ºC).
Do not freeze.
Pre-filled pen, single-dose; vial, single-dose:
Store in original package in order to protect from light.
Pre-filled pen (KwikPen), multi-dose:
For storage conditions after first use of the medicinal product, see section 6.3.
Pre-filled pen, single-dose:
Glass syringe encased in a disposable pre-filled pen.
The pre-filled pen has a hidden needle, which will automatically insert into the skin when the injection button is pressed.
Each pre-filled pen contains 0.5 ml of solution.
Pack sizes of 2 pre-filled pens, 4 pre-filled pens and multipack containing 12 (3 packs of 4) pre-filled pens. Not all pack sizes may be marketed.
Vial, single-dose:
Clear glass vial with a sealed stopper.
Each vial contains 0.5 ml of solution.
Pack sizes of 1 vial, 4 vials, 12 vials, multipack containing 4 (4 packs of 1) vials or multipack containing 12 (12 packs of 1) vials. Not all pack sizes may be marketed.
Pre-filled pen (KwikPen), multi-dose:
Clear glass cartridge encased in a multi-dose pre-filled pen.
Each pre-filled KwikPen contains 2.4 ml of solution for injection (4 doses of 0.6 ml). Each pen has excess volume for priming. However, attempting to inject any leftover medicinal product will result in an incomplete dose even though the pen still has medicinal product left in it. Needles are not included.
Pack sizes of 1 and 3 pre-filled KwikPens. Not all pack sizes may be marketed.
Inspect Mounjaro visually before use and discard for particulate matter or discolouration. Mounjaro that has been frozen must not be used.
Pre-filled pen, single-dose:
The pre-filled pen is for single-use only.
The instructions for using the pen, included with the package leaflet, must be followed carefully.
Vial, single-dose:
The vial is for single-use only.
The instructions in the package leaflet for how to inject Mounjaro from a vial must be followed carefully.
Pre-filled pen (KwikPen), multi-dose:
The pre-filled KwikPen is for multiple doses. Each KwikPen contains 4 doses. Dispose of the pen after 4 weekly doses.
The instructions for using the KwikPen, included with the package leaflet, must be followed carefully.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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