Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
Trulicity is indicated in adults with type 2 diabetes mellitus to improve glycaemic control as:
Monotherapy: When diet and exercise alone do not provide adequate glycaemic control in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications.
Add-on therapy: In combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see section 5.1 for data with respect to different combinations).
The recommended dose is 0.75 mg once weekly.
The recommended dose is 1.5 mg once weekly.
For potentially vulnerable populations, such as patients ≥75 years, 0.75 mg once weekly can be considered as a starting dose.
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.
No dose adjustment is required based on age (see section 5.2). However, the therapeutic experience in patients ≥75 years is very limited (see section 5.1), and in these patients 0.75 mg once weekly can be considered as a starting dose.
No dosage 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 dosage adjustment is required in patients with hepatic impairment.
The safety and efficacy of dulaglutide in children aged less than 18 years have not yet been established. No data are available.
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.
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.
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.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
