Ertugliflozindosage

Assess renal function prior to initiation and as clinically indicated. Correct volume depletion before initiation. Individualize the starting dosage based on the patient's current regimen. Maximum recommended dosage is 7.5 mg ertugliflozin/1,000 mg metformin orally twice daily. Take orally twice daily with meals, with gradual dose escalation. Do not use in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/minute/1.73 m 2. Use is not recommended in patients with an eGFR less than 45 mL/min/1.73 m 2. Use is contraindicated in patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m 2 ), end stage-renal disease (ESRD), or on dialysis. SEGLUROMET may need to be discontinued at time of, or prior to, iodinated contrast imaging procedures. Withhold SEGLUROMET for at least 4 days, if possible, prior to surgery or procedures associated with prolonged fasting.

2.1 Prior to

Initiation of SEGLUROMET Assess renal function before initiating SEGLUROMET and as clinically indicated. Assess volume status. In patients with volume depletion, correct this condition before initiating SEGLUROMET.

2.2 Recommended

Dosage Individualize the starting dosage of SEGLUROMET, ertugliflozin and metformin hydrochloride (HCI), based on the patient’s current regimen, while not exceeding the maximum recommended oral daily dosage of 15 mg ertugliflozin and 2,000 mg metformin HCl: In patients on metformin HCI, switch to SEGLUROMET tablets containing 2.5 mg ertugliflozin, with a similar total oral daily dosage of metformin HCl. In patients on ertugliflozin, switch to SEGLUROMET tablets containing 500 mg metformin HCl, with a similar total oral daily dosage of ertugliflozin. In patients already treated with ertugliflozin and metformin HCl, switch to SEGLUROMET tablets containing the same total oral daily dosage of ertugliflozin and a similar daily dosage of metformin HCI. Take SEGLUROMET orally twice daily with meals, with gradual dosage escalation for those initiating metformin HCl to reduce the gastrointestinal side effects due to metformin. Dosing may be adjusted based on effectiveness and tolerability. Use of SEGLUROMET is not recommended in patients with an estimated glomerular filtration rate (eGFR) less than 45 mL/min/1.73 m 2. Use of SEGLUROMET is contraindicated in patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m 2 ), end stage-renal disease (ESRD), or on dialysis.

2.3 Discontinuation for

Iodinated Contrast Imaging Procedures Discontinue SEGLUROMET at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR less than 60 mL/min/1.73 m 2; in patients with a history of liver disease, alcoholism or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure; restart SEGLUROMET if renal function is stable.

2.4 Temporary

Interruption for Surgery Withhold SEGLUROMET for at least 4 days, if possible, prior to surgery or procedures associated with prolonged fasting. Resume SEGLUROMET when the patient is clinically stable and has resumed oral intake.

2.5 Recommendations

Regarding Missed Dose If a dose is missed, instruct patients to take the dose as soon as possible. Advise patients not to double up the next dose.