Data 

 

Animal Data 

 

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 STEGLATRO 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).

 

8.4 Pediatric Use

 

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

 

8.5 Geriatric Use

 

No dosage adjustment of STEGLATRO is recommended based on age. Across the clinical program, a total of 876 (25.7%) patients treated with STEGLATRO were 65 years and older, and 152 (4.5%) patients treated with STEGLATRO 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, STEGLATRO 5 mg, and STEGLATRO 15 mg, respectively [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)]. STEGLATRO is expected to have diminished efficacy in elderly patients with renal impairment [see Use in Specific Populations (8.6)].

 

8.6 Renal Impairment

 

The safety and efficacy of STEGLATRO have not been established in patients with type 2 diabetes mellitus and moderate renal impairment [see Clinical Studies (14.4)]. Compared to placebo-treated patients, patients with moderate renal impairment treated with STEGLATRO did not have improvement in glycemic control [see Clinical Studies (14.4)], 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 (5.3) and Adverse Reactions (6.1)]. Therefore, STEGLATRO is not recommended in this population.

 

STEGLATRO is contraindicated in patients with severe renal impairment, ESRD, or receiving dialysis. STEGLATRO 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.

 

8.7 Hepatic Impairment

 

No dosage adjustment of STEGLATRO is necessary in patients with mild or moderate hepatic impairment. Ertugliflozin has not been studied in patients with severe hepatic impairment and is not recommended for use in this patient population [see Clinical Pharmacology (12.3)].

 

10 OVERDOSAGE 

  

 

In the event of an overdose with STEGLATRO, contact the Poison Control Center. Employ the usual supportive measures as dictated by the patient's clinical status. Removal of ertugliflozin by hemodialysis has not been studied.

 

11 DESCRIPTION 

 

STEGLATRO (ertugliflozin) tablets for oral use contain ertugliflozin L-pyroglutamic acid, a SGLT2 inhibitor.