Active Ingredient: Dulaglutide
Dulaglutide is indicated for the treatment of patients 10 years and above with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise in addition to other medicinal products for the treatment of diabetes.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Subcutaneous, between 1.5 milligrams dulaglutide and 4.5 milligrams dulaglutide, once weekly. The maximum allowed total dose is 4.5 milligrams dulaglutide weekly.
The recommended dose is 1.5 mg once weekly.
If needed,
The maximum dose is 4.5 mg once weekly.
When dulaglutide is added to existing metformin and/or pioglitazone therapy, the current dose of metformin and/or pioglitazone can be continued. When dulaglutide 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 it 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.
The use of dulaglutide does not require blood glucose self-monitoring. Blood glucose self-monitoring is necessary to adjust the dose of sulphonylurea or insulin, particularly when dulaglutide therapy is started and insulin is reduced. A stepwise approach to insulin dose reduction is recommended.
If a dose is missed, it should be administered as soon as possible if there are at least 3 days (72 hours) until the next scheduled dose. If less than 3 days (72 hours) remain before the next scheduled dose, the missed dose should be skipped and the next dose should be administered on the regularly scheduled day. In each case, patients can then resume their regular once weekly dosing schedule.
Dulaglutide is to be injected subcutaneously in the abdomen, thigh or upper arm. It should not be administered intravenously or intramuscularly.
The dose can be administered at any time of day, with or without meals.
The day of weekly administration can be changed if necessary, as long as the last dose was administered 3 or more days (72 hours) before.
For:
Subcutaneous, between 0.75 milligrams dulaglutide and 1.5 milligrams dulaglutide, once weekly.
The starting dose for paediatric patients 10 years and above is 0.75 mg once weekly.
If needed, the dose can be increased to 1.5 mg once weekly after at least 4 weeks. The maximum dose is 1.5 mg once weekly.
When dulaglutide is added to existing metformin and/or pioglitazone therapy, the current dose of metformin and/or pioglitazone can be continued. When dulaglutide 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 it 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.
The use of dulaglutide does not require blood glucose self-monitoring. Blood glucose self-monitoring is necessary to adjust the dose of sulphonylurea or insulin, particularly when dulaglutide therapy is started and insulin is reduced. A stepwise approach to insulin dose reduction is recommended.
If a dose is missed, it should be administered as soon as possible if there are at least 3 days (72 hours) until the next scheduled dose. If less than 3 days (72 hours) remain before the next scheduled dose, the missed dose should be skipped and the next dose should be administered on the regularly scheduled day. In each case, patients can then resume their regular once weekly dosing schedule.
Dulaglutide is to be injected subcutaneously in the abdomen, thigh or upper arm. It should not be administered intravenously or intramuscularly.
The dose can be administered at any time of day, with or without meals.
The day of weekly administration can be changed if necessary, as long as the last dose was administered 3 or more days (72 hours) before.
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