Posology : מינונים

4.2   Posology and method of administration

Posology
The recommended dose is one tablet twice daily. The dosage should be individualised on the basis of the patient’s current regimen, effectiveness, and tolerability using the recommended daily dose of 5 mg or 15 mg of ertugliflozin, while not exceeding the maximum recommended daily dose of metformin.

In patients with volume depletion, correcting this condition prior to initiation of Segluromet 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 Segluromet at the same time.

Adults with normal renal function (glomerular filtration rate [GFR] ≥ 90 mL/min) 
For patients inadequately controlled on metformin monotherapy or metformin in combination with other glucose-lowering medicinal products, including insulin
The recommended starting dose of Segluromet should provide ertugliflozin 2.5 mg twice daily (5 mg daily dose) and the dose of metformin similar to the dose already being taken. In patients tolerating a total daily dose of ertugliflozin 5 mg, the dose can be increased to a total daily dose of ertugliflozin 15 mg if additional glycaemic control is needed.

For patients switching from separate tablets of ertugliflozin and metformin Patients switching from separate tablets of ertugliflozin (5 mg or 15 mg total daily dose) and metformin to Segluromet should receive the same daily dose of ertugliflozin and metformin already being taken or the nearest therapeutically appropriate dose of metformin.

When Segluromet 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).

Special populations

Renal impairment
A GFR should be assessed before initiation of treatment with metformin-containing products and at least annually thereafter. In patients at increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g., every 3-6 months.

Initiation of this medicinal product is not recommended in patients with a GFR less than 60 mL/min (see section 4.4).

The maximum daily dose of metformin should preferably be divided into 2-3 daily doses. Factors that may increase the risk of lactic acidosis (see section 4.4) should be reviewed before considering initiation of metformin in patients with GFR < 60 mL/min.

If no adequate strength of Segluromet is available, individual monocomponents should be used instead of the fixed-dose combination.


GFR mL/min                 Metformin                               Ertugliflozin 
60-89                      Maximum daily dose is 3,000 mg.         Maximum daily dose is 15 mg.
Dose reduction may be considered in relation to declining renal function.
45-59                      Maximum daily dose is 2,000 mg.         Initiation is not recommended in
The starting dose is at most half of    patients with a glomerular the maximum dose.                       filtration rate less than 60 mL/min (see section 4.4).

Discontinue when GFR is persistently less than 45 mL/min.

30-44                      Maximum daily dose is 1,000 mg.         Not recommended.
The starting dose is at most half of the maximum dose.
< 30                       Metformin is contraindicated.           Not recommended.

Hepatic impairment
Segluromet is contraindicated in patients with hepatic impairment (see sections 4.3 and 4.4).

Elderly (≥ 65 years old)
Elderly patients are more likely to have decreased renal function. Because renal function abnormalities can occur after initiating ertugliflozin, and metformin is known to be substantially excreted by the kidneys, Segluromet should be used with caution in the elderly. Regular assessment of renal function is necessary to aid in prevention of metformin-associated lactic acidosis, particularly in elderly patients (see section 4.4). Renal function and risk of volume depletion should be taken into account (see sections 4.4 and 4.8).
There is limited experience with Segluromet in patients ≥ 75 years of age.

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

Method of administration
Segluromet should be taken orally twice daily with meals to reduce the gastrointestinal adverse reactions associated with metformin. In case of swallowing difficulties, the tablet could be broken or crushed as it is an immediate-release dosage form.