Steglatro

Posology 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. 8). 4). Missed dose 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. 4). 4). 73 m2, Steglatro should be initiated at 5 mg and up- titrated to 15 mg as needed for glycaemic control. 4). 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.

Hepatic impairment No dose adjustment of ertugliflozin is necessary in patients with mild or moderate hepatic impairment. 2). Elderly No dose adjustment of ertugliflozin is recommended based on age. 8). Paediatric population The safety and efficacy of ertugliflozin in children under 18 years of age have not been established.

No data are available. 4 Method of administration 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.

Summary of the safety profile The safety and tolerability of ertugliflozin were assessed in 7 placebo- or active comparator-controlled studies with a total of 3 409 patients with type 2 diabetes mellitus treated with ertugliflozin 5 mg or 15 mg.

9 years. Pool of placebo-controlled trials evaluating Steglatro 5 mg and 15 mg The primary assessment of safety was conducted in a pool of three 26-week, placebo-controlled trials. 1). These data reflect exposure of 1 029 patients to ertugliflozin with a mean exposure duration of approximately 25 weeks.

Patients received ertugliflozin 5 mg (N=519), ertugliflozin 15 mg (N=510), or placebo (N=515) once daily. The most commonly reported adverse reactions across the clinical program were urinary tract infections, vulvovaginal mycotic infection and other female genital mycotic infections.

4). Tabulated list of adverse reactions Adverse reactions listed below are classified according to frequency and system organ class (SOC), within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.

Frequency categories are defined according to the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000), not known (cannot be estimated from the available data).

4. † See subsections below for additional information. ‡ Includes: pollakiuria, micturition urgency, polyuria, urine output increased, and nocturia. § Includes: thirst and polydipsia. 9%. 5%. 6%). 1%). a Adverse reactions were identified through post-marketing surveillance.

10 Description of selected adverse reactions Volume depletion Ertugliflozin causes an osmotic diuresis, which may lead to intravascular volume contraction and adverse reactions related to volume depletion. In the pool of placebo-controlled studies, the incidence of adverse events related to volume depletion (dehydration, dizziness postural, presyncope, syncope, hypotension, and orthostatic hypotension) was low (< 2%) and not notably different across the ertugliflozin and placebo groups.

General Steglatro should not be used in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis (DKA) in these patients. Hypotension/Volume depletion Ertugliflozin causes an osmotic diuresis, which may lead to intravascular volume contraction.

73 m2 or CrCl less than 60 mL/min), elderly patients (≥ 65 years), patients on diuretics, or patients on anti-hypertensive therapy with a history of hypotension. Before initiating Steglatro, volume status should be assessed and corrected if indicated.

Monitor for signs and symptoms after initiating therapy. Due to its mechanism of action, ertugliflozin induces an osmotic diuresis and increases serum creatinine and decreases eGFR. 8). , physical examination, blood pressure measurements, laboratory tests including haematocrit) and electrolytes is recommended for patients receiving ertugliflozin.

Temporary interruption of treatment with ertugliflozin should be considered until the fluid loss is corrected. Diabetic ketoacidosis Rare cases of DKA, including life-threatening and fatal cases, have been reported in clinical trials and post-marketing in patients treated with sodium glucose co-transporter-2 (SGLT2) inhibitors, including ertugliflozin.

In a number of cases, the presentation of the condition was atypical with only moderately increased blood glucose values, below 14 mmol/L (250 mg/dL). It is not known if DKA is more likely to occur with higher doses of ertugliflozin.

The risk of DKA must be considered in the event of non-specific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness. Patients should be assessed for ketoacidosis immediately if these symptoms occur, regardless of blood glucose level.

In patients where DKA is suspected or diagnosed, treatment with ertugliflozin should be discontinued immediately. Treatment should be interrupted in patients who are hospitalised for major surgical procedures or acute serious medical illnesses.

1.