Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Steglatro is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:
For study results with respect to combinations of therapies, effects on glycaemic control, cardiovascular events, and the populations studied, see sections 4.4, 4.5, and 5.1.
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).
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.
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 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, Steglatro should be initiated at 5 mg and uptitrated to 15 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).
Steglatro should be discontinued when eGFR is persistently less than 30 mL/min/1.73 m² or CrCl is persistently less than 30 mL/min.
Steglatro 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 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).
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).
The safety and efficacy of ertugliflozin in children under 18 years of age have not been established. No data are available.
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.
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.
In the event of an overdose, employ the usual supportive measures (e.g. remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive treatment) as dictated by the patient’s clinical status. Removal of ertugliflozin by haemodialysis has not been studied.
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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