Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
Trulicity 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
For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.
Monotherapy: The recommended dose is 0.75 mg once weekly.
Add-on therapy: The recommended dose is 1.5 mg once weekly.
If needed,
The maximum dose is 4.5 mg 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 Trulicity is added to existing metformin and/or pioglitazone therapy, the current dose of metformin and/or pioglitazone can be continued. When Trulicity 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 (see sections 4.4 and 4.8).
The use of Trulicity does not require blood glucose self-monitoring. Blood glucose self-monitoring is necessary to adjust the dose of sulphonylurea or insulin, particularly when Trulicity 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.
No dose adjustment is required based on age (see section 5.2).
No dose adjustment is required in patients with mild, moderate or severe renal impairment (eGFR <90 to ≥15 mL/min/1.73m²). There is very limited experience in patients with end stage renal disease (<15 ml/min/1.73m²), therefore Trulicity cannot be recommended in this population (see sections 5.1 and 5.2).
No dose adjustment is required in patients with hepatic impairment.
The safety and efficacy of dulaglutide in children aged less than 10 years have not been established and no data are available (see sections 5.1 and 5.2).
Trulicity 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.
Effects of overdose with dulaglutide in clinical studies have included gastrointestinal disorders and hypoglycaemia. In the event of overdose, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms.
2 years.
Store in a refrigerator (2°C–8°C).
Do not freeze.
Store in original package in order to protect from light.
In use: Trulicity may be stored unrefrigerated for up to 14 days at a temperature not above 30°C.
Glass syringe (type I) encased in a disposable pen.
Each pre-filled pen contains 0.5 ml of solution.
Packs of 2 and 4 pre-filled pens and multipack of 12 (3 packs of 4) pre-filled pens. Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
The pre-filled pen is for single-use only.
The instructions for using the pen, included with the package leaflet, must be followed carefully.
Trulicity should not be used if particles appear or if the solution is cloudy and/or discoloured.
Trulicity that has been frozen must not be used.
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