Pregnancy: Advise females of the potential risk to a fetus especially during the second and third trimesters. (8.1)

Lactation: Breastfeeding not recommended. (8.2)

Geriatrics: Higher incidence of adverse reactions related to reduced intravascular volume. (5.1, 8.5)

Renal Impairment: Higher incidence of adverse reactions related to reduced intravascular volume and renal function. (5.1, 5.3, 8.6)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

 

Revised: 12/2017

 

FULL PRESCRIBING INFORMATION: CONTENTS* 

 

1 INDICATIONS AND USAGE 

 

2 DOSAGE AND ADMINISTRATION 

 

2.1 Recommended Dosage 

 

2.2 Patients with Renal Impairment 

 

3 DOSAGE FORMS AND STRENGTHS 

 

4 CONTRAINDICATIONS 

 

5 WARNINGS AND PRECAUTIONS 

 

5.1 Hypotension 

 

5.2 Ketoacidosis 

 

5.3 Acute Kidney Injury and Impairment in Renal Function 

 

5.4 Urosepsis and Pyelonephritis 

 

5.5 Lower Limb Amputation 

 

5.6 Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues 

 

5.7 Genital Mycotic Infections 

 

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

 

5.9 Macrovascular Outcomes 

 

6 ADVERSE REACTIONS 

 

6.1 Clinical Trials 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 

 

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 Clinical Study of Monotherapy Use of STEGLATRO in Patients with Type 2 Diabetes Mellitus 

 

14.3 Clinical Studies of Combination Therapy Use of STEGLATRO in Patients with Type 2 Diabetes Mellitus 

 

14.4 Clinical Study of STEGLATRO in Patients with Moderate Renal Impairment and Type 2 Diabetes Mellitus 

 

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