QTERN Film-coated tablet Ref.[7953] Active ingredients: Dapagliflozin Saxagliptin Saxagliptin and Dapagliflozin

Posology

The recommended dose is one 5 mg saxagliptin/10 mg dapagliflozin tablet once daily (see sections 4.5 and 4.8).

Missed dose

If a dose is missed and it is ≥12 hours until the next dose, the dose should be taken. If a dose is missed and it is <12 hours until the next dose, the missed dose should be skipped and the next dose taken at the usual time.

Special populations

Renal impairment

Qtern should not be initiated in patients with a glomerular filtration rate (GFR) <60 mL/min and should be discontinued at GFR persistently below 45 mL/min. It should also not be used in patients with end-stage renal disease (ESRD) (see sections 4.4, 4.8, 5.1 and 5.2).

No dose adjustment is recommended based on renal function.

Hepatic impairment

This medicinal product can be used in patients with mild or moderate hepatic impairment. Patients with moderate hepatic impairment should be evaluated prior to initiation and during treatment. It is not recommended for use in patients with severe hepatic impairment (see section 4.4).

Elderly (≥65 years)

No dose adjustment is recommended based on age. Renal function and risk of volume depletion should be taken into account (see sections 4.4 and 5.2).

Paediatric population

The safety and efficacy of this medicinal product in children and adolescents aged 0 to <18 years have not yet been established. No data are available.

Method of administration

Qtern is taken orally once daily. It may be taken at any time of day with or without food. Tablet is to be swallowed whole.

There is no information available on overdose with the saxagliptin/dapagliflozin fixed dose combination. In the event of an overdose, appropriate supportive treatment should be initiated as dictated by the patient’s clinical status.

Saxagliptin

Saxagliptin had no clinically meaningful effect on QTc interval or heart rate at oral doses up to 400 mg daily for 2 weeks (80 times the recommended dose). Saxagliptin and its major metabolite are removed by haemodialysis (23% of dose over four hours).

Dapagliflozin

Dapagliflozin did not show any toxicity in healthy subjects at single oral doses up to 500 mg (50 times the maximum recommended human dose). These subjects had detectable glucose in the urine for a dose-related period of time (at least 5 days for the 500 mg dose), with no reports of dehydration, hypotension or electrolyte imbalance, and with no clinically meaningful effect on QTc interval. The incidence of hypoglycaemia was similar to placebo. In clinical studies where once-daily doses of up to 100 mg (10 times the maximum recommended human dose) were administered for 2 weeks in healthy subjects and type 2 diabetes subjects, the incidence of hypoglycaemia was slightly higher than placebo and was not dose-related. Rates of adverse events including dehydration or hypotension were similar to placebo, and there were no clinically meaningful dose-related changes in laboratory parameters, including serum electrolytes and biomarkers of renal function. The removal of dapagliflozin by haemodialysis has not been studied.

3 years.

This medicinal product does not require any special storage conditions.

PA/Alu/PVC-Alu blister.

Pack sizes of 14, 28, and 98 film-coated tablets in calendar blisters.

Pack size of 30 film-coated tablets in blisters.

Not all pack sizes may be marketed.

PA/Alu/PVC-Alu blister.

Pack sizes of 14, 28, and 98 film-coated tablets in calendar blisters.

Pack size of 30 film-coated tablets in blisters.

Not all pack sizes may be marketed.