Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Steglujan is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise:
(For study results with respect to combinations and effects on glycaemic control, see sections 4.4, 4.5, and 5.1)
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.
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 45 mL/min/1.73 m² or creatinine clearance (CrCl) less than 45 mL/min (see section 4.4).
In patients with an eGFR ≥45 to <60 mL/min/1.73 m², Steglujan should be initiated at 5 mg/100 mg and up-titrated to 15 mg/100 mg as needed for glycaemic control.
Because the glycaemic lowering efficacy of ertugliflozin is reduced in patients with moderate renal impairment and likely absent in patients with severe renal impairment, if further glycaemic control is needed, the addition of other anti-hyperglycaemic agents should be considered (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, as there is no clinical data to support effectiveness in these patients.
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).
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).
The safety and efficacy of Steglujan in children under 18 years of age have not been established. No data are available.
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.
In the event of an overdose with Steglujan, employ the usual supportive measures (e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring including obtaining an electrocardiogram, and institute supportive treatment) as dictated by the patient’s clinical status.
Ertugliflozin did not show any toxicity in healthy subjects at single oral doses up to 300 mg and multiple doses up to 100 mg daily for 2 weeks. No potential acute symptoms and signs of overdose were identified. Removal of ertugliflozin by haemodialysis has not been studied.
During controlled clinical trials in healthy subjects, single doses of up to 800 mg sitagliptin were administered. Minimal increases in QTc, not considered to be clinically relevant, were observed in one study at a dose of 800 mg sitagliptin. There is no experience with doses above 800 mg in clinical studies. In phase 1 multiple-dose studies, there were no dose-related clinical adverse reactions observed with sitagliptin with doses of up to 600 mg per day for periods of up to 10 days and 400 mg per day for periods of up to 28 days.
Sitagliptin is modestly dialysable. In clinical studies, approximately 13.5% of the dose was removed over a 3- to 4-hour haemodialysis session. Prolonged haemodialysis may be considered if clinically appropriate. It is not known if sitagliptin is dialysable by peritoneal dialysis.
2 years.
This medicinal product does not require any special storage conditions.
Alu/PVC/PA/Alu blisters.
Packs of 14, 28, 30, 84, 90 and 98 film-coated tablets in non-perforated blisters.
Packs of 30x1 film-coated tablets in perforated unit dose blisters.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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