TRULICITY INJECTION 1.5MG/0.5ML

INJECTION, SOLUTION

**4.2 Posology and method of administration** Posology _Monotherapy_ The recommended dose is 0.75 mg once weekly. _Add-on therapy_ The recommended dose is 1.5 mg once weekly. For potentially vulnerable populations 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 – _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 18 years have not yet been established. No data are available. 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.