5.4 Acute Kidney Injury and Impairment in Renal Function 

 

5.5 Urosepsis and Pyelonephritis 

 

5.6 Lower Limb Amputation 

 

5.7 Heart Failure 

 

5.8 Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues 

 

5.9 Genital Mycotic Infections 

 

5.10 Hypersensitivity Reactions 

 

5.11 Increases in Low-Density Lipoprotein Cholesterol (LDL-C) 

 

5.12 Severe and Disabling Arthralgia 

 

5.13 Bullous Pemphigoid 

 

5.14 Macrovascular Outcomes 

 

6 ADVERSE REACTIONS 

 

6.1 Clinical Trials Experience 

 

6.2 Postmarketing Experience 

 

7 DRUG INTERACTIONS 

 

7.1 Concomitant Use with Insulin and Insulin Secretagogues 

 

7.2 Positive Urine Glucose Test 

 

7.3 Interference with 1,5-anhydroglucitol (1,5-AG) Assay 

 

7.4 Digoxin 

 

8 USE IN SPECIFIC POPULATIONS 

 

8.1 Pregnancy 

 

8.2 Lactation 

 

8.4 Pediatric Use 

 

8.5 Geriatric Use 

 

8.6 Renal Impairment 

 

8.7 Hepatic Impairment 

 

10 OVERDOSAGE 

 

11 DESCRIPTION 

 

12 CLINICAL PHARMACOLOGY 

 

12.1 Mechanism of Action 

 

12.2 Pharmacodynamics 

 

12.3 Pharmacokinetics 

 

13 NONCLINICAL TOXICOLOGY 

 

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 

 

14 CLINICAL STUDIES 

14.1 Overview of Clinical Studies in Patients with Type 2 Diabetes Mellitus 

 

14.2 In Combination with Sitagliptin versus Ertugliflozin Alone and Sitagliptin Alone, as Add-on to Metformin 

 

14.3 Ertugliflozin as Add-on Combination Therapy with Metformin and Sitagliptin 

 

14.4 Initial Combination Therapy of Ertugliflozin and Sitagliptin 

 

16 HOW SUPPLIED/STORAGE AND HANDLING 

17 PATIENT COUNSELING INFORMATION 

* Sections or subsections omitted from the full prescribing information are not listed. Close 

1 INDICATIONS AND USAGE

STEGLUJAN™ is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both ertugliflozin and sitagliptin is appropriate.

Limitations of Use 

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

STEGLUJAN has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using STEGLUJAN. [See Warnings and Precautions (5.1).]  

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage