Hepatic impairment: Avoid use in patients with hepatic impairment. (8.7)

 

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

 

Revised: 12/2017

 

FULL PRESCRIBING INFORMATION: CONTENTS* 

 

WARNING: LACTIC ACIDOSIS 

 

1 INDICATIONS AND USAGE 

 

2 DOSAGE AND ADMINISTRATION 

 

2.1 Recommended Dosage 

 

2.2 Patients with Renal Impairment 

 

2.3 Discontinuation for Iodinated Contrast Imaging Procedures 

 

3 DOSAGE FORMS AND STRENGTHS 

 

4 CONTRAINDICATIONS 

 

5 WARNINGS AND PRECAUTIONS 

 

5.1 Lactic Acidosis 

 

5.2 Hypotension 

 

5.3 Ketoacidosis 

 

5.4 Acute Kidney Injury and Impairment in Renal Function 

 

5.5 Urosepsis and Pyelonephritis 

 

5.6 Lower Limb Amputation 

 

5.7 Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues 

 

5.8 Genital Mycotic Infections 

 

5.9 Vitamin B12 Levels 

 

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

 

5.11 Macrovascular Outcomes 

 

6 ADVERSE REACTIONS 

 

6.1 Clinical Trials Experience 

 

7 DRUG INTERACTIONS 

 

7.1 Drug Interactions with Ertugliflozin 

 

7.2 Drug Interactions with Metformin Hydrochloride 

 

8 USE IN SPECIFIC POPULATIONS 

 

8.1 Pregnancy 

 

8.2 Lactation 

 

8.3 Females and Males of Reproductive Potential 

 

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 Ertugliflozin as Add-on Combination Therapy with Metformin 

 

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

 

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

 

14.5 Active Controlled Study of Ertugliflozin Versus Glimepiride as Add-on Combination Therapy with Metformin 

 

16 HOW SUPPLIED/STORAGE AND HANDLING 

 

17 PATIENT COUNSELING INFORMATION 

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

1 INDICATIONS AND USAGE