Method of administration and dosage

Dosage

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 or sodium-glucose co-transporter 2 inhibitor (SGLT2i) therapy, the current dose of metformin or SGLT2i can be continued.

When Tirzepatide is added to existing therapy of a sulphonylurea 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.

For weight management

If patients can’t lose at least 5% of their starting body weight within 6 months after ending of the highest tolerated dose, it shall be advised to continue the treatment and it shall be estimated by considering the benefit/loss profile of individual patient.

Missed dose

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

No dose adjustment is needed based on age, gender, race, ethnicity or body weight.

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.

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.

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

The medicine 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 Tirzepatide 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.