STEGLUJAN

General Introduction Ertugliflozin The pharmacokinetics of ertugliflozin are similar in healthy subjects and patients with type 2 diabetes mellitus. The steady state mean plasma AUC and C max were 398 ng∙hr/mL and 81.3 ng/mL, respectively, with 5 mg ertugliflozin once daily treatment, and 1,193 ng∙hr/mL and 268 ng/mL, respectively, with 15 mg ertugliflozin once daily treatment. Steady-state is reached after 4 to 6 days of once-daily dosing with ertugliflozin. Ertugliflozin does not exhibit time-...

14.1 Glycemic Control Trials in Patients with Type 2 Diabetes Mellitus The efficacy and safety of ertugliflozin in combination with sitagliptin have been studied in 3 multi-center, randomized, double-blind, placebo- and active comparator-controlled, clinical studies involving 1,985 patients with type 2 diabetes mellitus. These studies included White, Hispanic or Latino, Black or African American, Asian, and other racial and ethnic groups, and patients with an age range of 21 to 85 years. In patients with type 2 diabetes mellitus, treatment with ertugliflozin in combination with sitagliptin red...

The following important adverse reactions are described elsewhere in the labeling: Diabetic Ketoacidosis in Patients with Type 1 Diabetes and Other Ketoacidosis [see Warnings and Precautions (5.1) ] Pancreatitis [see Warnings and Precautions (5.2) ] Lower Limb Amputation [see Warnings and Precautions (5.3) ] Acute Renal Failure [see Warnings and Precautions (5.4) ] Volume Depletion [see Warnings and Precautions (5.5) ] Urosepsis and Pyelonephritis [see Warnings and Precautions (5.6) ] Heart Fail...

STEGLUJAN is contraindicated in patients with: Severe renal impairment (eGFR less than 30 mL/min/1.73 m 2 ), end-stage renal disease (ESRD), or on dialysis [see Warnings and Precautions (5.4) and Use in Specific Populations (8.6) ] . Hypersensitivity to sitagliptin, ertugliflozin, or any excipient, in STEGLUJAN. Reactions such as anaphylaxis or angioedema have occurred [see Warnings and Precaution...

Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis: Consider ketone monitoring in patients at risk for ketoacidosis, as indicated. Assess for ketoacidosis regardless of presenting blood glucose levels and discontinue STEGLUJAN if ketoacidosis is suspected. Monitor patients for resolution of ketoacidosis before restarting. ( 5.1 ) Pancreatitis: There have been postmarketing reports of acute pancreatitis in patients taking sitagliptin, including fatal and non-fa...

7 DRUG INTERACTIONS

Table 3Clinically Significant Drug Interactions with STEGLUJAN Insulin or Insulin Secretagogues Clinical Impact: The risk of hypoglycemia is increased when STEGLUJAN is used in combination with insulin or an insulin secretagogue. Intervention: A lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used in combination with STE...