Prior to Initiation of SEGLUROMET

• Assess renal function prior to initiation of SEGLUROMET and as clinically indicated [see Warnings and Precautions (5.2)].
• In patients with volume depletion, correct this condition before initiating SEGLUROMET [see Warnings and Precautions (5.4), Use in Specific Populations (8.5, 8.6)].

Recommended Dosage

• Individualize the starting dose of SEGLUROMET, ertugliflozin and metformin hydrochloride (HCl), based on the patient’s current regimen, while not exceeding the maximum recommended daily dose of 15 mg ertugliflozin and 2,000 mg metformin HCl:
  • In patients on metformin HCl, switch to SEGLUROMET tablets containing 2.5 mg ertugliflozin, with a similar total daily dose of metformin HCl.
  • In patients on ertugliflozin, switch to SEGLUROMET tablets containing 500 mg metformin HCl, with a similar total daily dose of ertugliflozin.
  • In patients already treated with ertugliflozin and metformin HCl, switch to SEGLUROMET tablets containing the same total daily dose of ertugliflozin and a similar daily dose of metformin HCl.
• Take SEGLUROMET twice daily with meals, with gradual dose escalation for those initiating metformin HCl to reduce the gastrointestinal side effects due to metformin [see Adverse Reactions (6.1)].
• Dosing may be adjusted based on effectiveness and tolerability.
• Use of SEGLUROMET is not recommended in patients with an eGFR less than 45 mL/min/1.73 m2.
• Use of SEGLUROMET is contraindicated in patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m2), end stage-renal disease (ESRD), or on dialysis [see Contraindications (4)].

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 m2; 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 [see Warnings and Precautions (5.1)].