TRULICITY INJECTION 0.75MG/0.5ML [SIN14968P]

Product Info

TRULICITY INJECTION 0.75MG/0.5ML

[SIN14968P]

4.1 Therapeutic indications

Type 2 Diabetes Mellitus

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

• as monotherapy when metformin is considered inappropriate due to intolerance or contraindications

• in addition to other medicinal products for the treatment of diabetes.

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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

4.2 Posology and method of administration

Posology

Adults

Monotherapy
The recommended dose is 0.75 mg once weekly.

Add-on therapy
The recommended dose is 1.5 mg once weekly.

Paediatrics

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.

Combination therapy
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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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.

Missed doses

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.

Special population
Elderly
No dose adjustment is required based on age (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal impairment
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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment
No dose adjustment is required in patients with hepatic impairment.

Paediatric population
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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Method of administration

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.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.