SEGLUROMET™ is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are not adequately controlled on a regimen containing ertugliflozin or metformin, or in patients who are already treated with both ertugliflozin and metformin.

 

Limitations of Use 

SEGLUROMET is not recommended in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

 

2 DOSAGE AND ADMINISTRATION 

 

2.1 Recommended Dosage

 Individualize the starting dose of SEGLUROMET (ertugliflozin and metformin hydrochloride) 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, switch to SEGLUROMET tablets containing 2.5 mg ertugliflozin, with a similar total daily dose of metformin.

In patients on ertugliflozin, switch to SEGLUROMET tablets containing 500 mg metformin, with a similar total daily dose of ertugliflozin.

In patients already treated with ertugliflozin and metformin, switch to SEGLUROMET tablets containing the same total daily dose of ertugliflozin and a similar daily dose of metformin.

 

Take SEGLUROMET twice daily with meals, with gradual dose escalation for those initiating metformin to reduce the gastrointestinal side effects due to metformin [see Adverse Reactions (6.1)].

In patients with volume depletion not previously treated with ertugliflozin, correct this condition prior to initiation of SEGLUROMET [see Warnings and Precautions (5.2)].

Dosing may be adjusted based on effectiveness and tolerability.

 

2.2 Patients with Renal Impairment

 Assess renal function prior to initiation of SEGLUROMET and periodically thereafter [see Warnings and Precautions (5.4)].

Use of SEGLUROMET is contraindicated in patients with an eGFR less than 30 mL/minute/1.73 m2 [see Contraindications (4)].

Initiation of SEGLUROMET is not recommended in patients with an eGFR of 30 mL/minute/1.73 m2 to less than 60 mL/minute/1.73 m2 [see Warnings and Precautions (5.4) and Use in Specific Populations (8.6)].

Continued use of SEGLUROMET is not recommended when eGFR is persistently between 30 and less than 60 mL/min/1.73 m2.

No dose adjustment is needed in patients with mild renal impairment.

 

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 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-eva luate eGFR 48 hours after the imaging procedure; restart SEGLUROMET if renal function is stable [see Warnings and Precautions (5.1)].

 

3 DOSAGE FORMS AND STRENGTHS 

  

Tablets: ertugliflozin 2.5 mg and metformin hydrochloride 500 mg, pink, oval, debossed with "2.5/500" on one side and plain on the other side.

Tablets: ertugliflozin 2.5 mg and metformin hydrochloride 1000 mg, pink, oval, debossed with "2.5/1000" on one side and plain on the other side.