Posology : מינונים

4.2   Posology and method of administration

Posology

The recommended starting dose of ertugliflozin is 5 mg once daily. In patients tolerating ertugliflozin 5 mg once daily, the dose can be increased to 15 mg once daily if additional glycaemic control is needed.

When ertugliflozin is used in combination with insulin or an insulin secretagogue, a lower dose of insulin or the insulin secretagogue may be required to reduce the risk of hypoglycaemia (see sections 4.4, 4.5, and 4.8).

In patients with volume depletion, correcting this condition prior to initiation of ertugliflozin is recommended (see section 4.4).

Missed dose

If a dose is missed, it should be taken as soon as the patient remembers. Patients should not take two doses of Steglatro on the same day.

Special populations

Renal impairment
Assessment of renal function is recommended prior to initiation of Steglatro and periodically thereafter (see section 4.4).

Initiation of this medicinal product is not recommended in patients with an estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73 m2 or creatinine clearance (CrCl) less than 60 mL/min (see section 4.4).

Steglatro should be discontinued when eGFR is persistently less than 45 mL/min/1.73 m2 or CrCl is persistently less than 45 mL/min.

Steglatro should not be used in patients with severe renal impairment, with end-stage renal disease (ESRD), or receiving dialysis, as it is not expected to be effective in these patients.

Hepatic impairment
No dose adjustment of ertugliflozin is necessary in patients with mild or moderate hepatic impairment.
Ertugliflozin has not been studied in patients with severe hepatic impairment and is not recommended for use in these patients (see section 5.2).

Elderly
No dose adjustment of ertugliflozin is recommended based on age. Renal function and risk of volume depletion should be taken into account (see sections 4.4 and 4.8). There is limited experience with Steglatro in patients ≥ 75 years of age.

Paediatric population
The safety and efficacy of ertugliflozin in children under 18 years of age have not been established.
No data are available.

Method of administration
Steglatro should be taken orally once daily in the morning, with or without food. In case of swallowing difficulties, the tablet could be broken or crushed as it is an immediate-release dosage form.