Ertugliflozin 

 

Across the clinical program, a total of 876 (25.7%) patients treated with ertugliflozin were 65 years and older, and 152 (4.5%) patients treated with ertugliflozin were 75 years and older. Patients 65 years and older had a higher incidence of adverse reactions related to volume depletion compared to younger patients; events were reported in 1.1%, 2.2%, and 2.6% of patients treated with comparator, ertugliflozin 5 mg, and ertugliflozin 15 mg, respectively [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)].

 

Metformin hydrochloride 

 

Controlled clinical studies of metformin did not include sufficient numbers of elderly patients to determine whether they respond differently from younger patients, although other reported clinical experience has not identified differences in responses between the elderly and young patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy and the higher risk of lactic acidosis. Assess renal function more frequently in elderly patients. [See Contraindications (4), Warnings and Precautions (5.1), and Clinical Pharmacology (12.3).] 

 

8.6 Renal Impairment

 

The safety and efficacy of ertugliflozin have not been established in patients with type 2 diabetes mellitus and moderate renal impairment. Compared to placebo-treated patients, patients with moderate renal impairment treated with ertugliflozin did not have improvement in glycemic control and had increased risks for renal impairment, renal-related adverse reactions, and volume depletion adverse reactions [see Dosage and Administration (2.2), Warnings and Precautions (5.4), and Adverse Reactions (6.1)]. Therefore, SEGLUROMET is not recommended in this population.

 

SEGLUROMET is contraindicated in patients with severe renal impairment, ESRD, or receiving dialysis. SEGLUROMET is not expected to be effective in these patient populations [see Contraindications (4)]. 

 

No dosage adjustment or increased monitoring is needed in patients with mild renal impairment.

 

Metformin is substantially excreted by the kidney, and the risk of metformin accumulation and lactic acidosis increases with the degree of renal impairment.

 

8.7 Hepatic Impairment

 

Use of metformin in patients with hepatic impairment has been associated with some cases of lactic acidosis. SEGLUROMET is not recommended in patients with hepatic impairment [see Warnings and Precautions (5.1)].

 

10 OVERDOSAGE 

 

SEGLUROMET 

 

In the event of an overdose with SEGLUROMET, contact the Poison Control Center. Employ the usual supportive measures as dictated by the patient's clinical status.

 

Ertugliflozin 

 

Removal of ertugliflozin by hemodialysis has not been studied.

Metformin hydrochloride