Insufficiently controlled type 2 diabetes mellitus

Active Ingredient: Tirzepatide

Indication for Tirzepatide

Population group: only adults (18 years old or older)
Therapeutic intent: Curative procedure

Tirzepatide is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:

  • as monotherapy when metformin is considered inappropriate due to intolerance or contraindications.
  • in addition to other medicinal products for the treatment of diabetes.

For this indication, competent medicine agencies globally authorize below treatments:

2.5 mg once weekly for 4 weeks and 5 mg once weekly thereafter

For:

Dosage regimens

Regimen A: Subcutaneous, 2.5 milligrams tirzepatide, once weekly, over the duration of 4 weeks. Afterwards, subcutaneous, 5 milligrams tirzepatide, once weekly.

Regimen B: Subcutaneous, 2.5 milligrams tirzepatide, once weekly, over the duration of 4 weeks. Afterwards, subcutaneous, 5 milligrams tirzepatide, once weekly, over the duration of 4 weeks. Afterwards, subcutaneous, 10 milligrams tirzepatide, once weekly.

Regimen C: Subcutaneous, 2.5 milligrams tirzepatide, once weekly, over the duration of 4 weeks. Afterwards, subcutaneous, 5 milligrams tirzepatide, once weekly, over the duration of 4 weeks. Afterwards, subcutaneous, 10 milligrams tirzepatide, once weekly, over the duration of 4 weeks. Afterwards, subcutaneous, 15 milligrams tirzepatide, once weekly.

Detailed description

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, 10 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.

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.

Dosage considerations

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.

Active ingredient

Tirzepatide

Tirzepatide is a long acting dual GIP and GLP-1 receptor agonist. Both receptors are present on the pancreatic α and β endocrine cells, brain, heart, vasculature, immune cells (leukocytes), gut and kidney. GIP receptors are also present on adipocytes. The activity of tirzepatide on the GIP receptor is similar to native GIP hormone. Tirzepatide improves glycaemic control by lowering fasting and postprandial glucose concentrations in patients with type 2 diabetes through several mechanisms.

Read more about Tirzepatide

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