Posology : מינונים

4.2   Posology and method of administration

Posology
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).

Missed doses

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.

Changing the 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.


Special populations
Elderly, gender, race, ethnicity or body weight
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.

Renal impairment
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).

Hepatic impairment
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).

Paediatric population
The safety and efficacy of tirzepatide in children aged less than 18 years have not yet been established.
No data are available.

Method of administration
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.

For further information before administration see section 6.6.