Data 

Animal Data

Ertugliflozin 

The lacteal excretion of radiolabeled ertugliflozin in lactating rats was eva luated 10 to 12 days after parturition. Ertugliflozin-derived radioactivity exposure in milk and plasma were similar, with a milk/plasma ratio of 1.07, based on AUC. Juvenile rats directly exposed to ertugliflozin during a developmental period corresponding to human kidney maturation were associated with a risk to the developing kidney (persistent increased organ weight, renal mineralization, and renal pelvic and tubular dilatations).

Sitagliptin 

Sitagliptin is secreted in the milk of lactating rats at a milk to plasma ratio of 4:1.

8.4 Pediatric Use

Safety and effectiveness of STEGLUJAN in pediatric patients under 18 years of age have not been established.

8.5 Geriatric Use

STEGLUJAN 

No dosage adjustment of STEGLUJAN is recommended based on age. Elderly patients are more likely to have decreased renal function. Because renal function abnormalities can occur after initiating ertugliflozin, and sitagliptin is known to be substantially excreted by the kidneys, renal function should be assessed more frequently in elderly patients [see Dosage and Administration (2.2) and Warnings and Precautions (5.4)]. STEGLUJAN is expected to have diminished efficacy in elderly patients with renal impairment [see Use in Specific Populations (8.6)].

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)].

Sitagliptin 

Of the total number of subjects (N=3,884) in pre-approval clinical safety and efficacy studies of sitagliptin, 725 patients were 65 years and over, while 61 patients were 75 years and over. No overall differences in safety or effectiveness were observed between subjects 65 years and over and younger subjects. While this and other reported clinical experience have not identified differences in responses between the elderly and younger patients, greater sensitivity of some older individuals cannot be ruled out.

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, STEGLUJAN is not recommended in this population.