Posology : מינונים

4.2      Posology and method of administration

Posology
The recommended starting dose is 5 mg ertugliflozin/100 mg sitagliptin once daily. In patients tolerating the starting dose, the dose may be increased to 15 mg ertugliflozin/100 mg sitagliptin, once daily, if additional glycaemic control is needed.

For patients treated with ertugliflozin who are being switched to Steglujan, the dose of ertugliflozin can be maintained.

When Steglujan 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 Steglujan is recommended (see section 4.4).

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

Special populations

Renal impairment
Assessment of renal function is recommended prior to initiation of Steglujan 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 CrCl less than 60 mL/min (see section 4.4).

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

The fixed-dose combination of ertugliflozin and sitagliptin should not be used in patients with severe renal impairment, with end-stage renal disease (ESRD), or receiving dialysis. Ertugliflozin is not expected to be effective in these patients.

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

Elderly (≥ 65 years old)
No dose adjustment of Steglujan is recommended based on age. Elderly patients are more likely to have decreased renal function. Because renal function abnormalities can occur after initiating ertugliflozin, and sitagliptin is known to be substantially excreted by the kidneys, renal function should be assessed more frequently in elderly patients. Renal function and risk of volume depletion should be taken into account (see sections 4.4 and 4.8). There is limited experience with Steglujan in patients ≥ 75 years of age.

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

Method of administration
Steglujan 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.