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JARDIANCE has a demonstrated safety and<br> tolerability profile

ACROSS MULTIPLE TRIALS

JARDIANCE has a demonstrated safety and
tolerability profile

COMMON AEs IN CV OUTCOME TRIAL1

PLACEBO
JARDIANCE*
Urinary tract infection
18.1%
18.0%
Genital mycotic infection
1.8%
6.4%

THE SAFETY PROFILE IN THE JARDIANCE CV OUTCOME TRIAL WAS CONSISTENT WITH THAT OF PREVIOUS TRIALS

COMMON AEs IN MONOTHERAPY AND COMBINATION THERAPY TRIALS

PLACEBO
JARDIANCE
10 mg
JARDIANCE
25 mg
 
(N=995)
(N=999)
(N=977)
Urinary tract infection
7.6%
9.3%
7.6%
UTIs: Males
3.2%
3.6%
4.1%
UTIs: Females
16.6%
18.4%
17.0%
Female genital mycotic infections
1.5%
5.4%
6.4%
Upper respiratory tract infection
3.8%
3.1%
4.0%
Increased urination
1.0%
3.4%
3.2%
Dyslipidemia
3.4%
3.9%
2.9%
Arthralgia
2.2%
2.4%
2.3%
Male genital mycotic infections
0.4%
3.1%
1.6%
Nausea
1.4%
2.3%
1.1%

JARDIANCE demonstrated similar hypoglycemia rates to placebo when used as monotherapy or add-on to metformin

Incidence of overall and severe hypoglycemic events with JARDIANCE

Monotherapy
(24 weeks)
 
PLACEBO
 
JARDIANCE
10 mg
JARDIANCE
25 mg
 
(n=229)
(n=224)
(n=223)
Overall (plasma glucose ≤70 mg/dL)
0.4%
0.4%
0.4%
Severe (requiring assistance regardless of blood glucose)
0%
0%
0%
Add-On to METFORMIN
(24 weeks)
 
PLACEBO
 
JARDIANCE
10 mg
JARDIANCE
25 mg
 
(n=206)
(n=217)
(n=214)
Overall (plasma glucose ≤70 mg/dL)
0.5%
1.8%
1.4%
Severe (requiring assistance regardless of blood glucose)
0%
0%
0%

Hypoglycemia rates were higher when used
in combination with sulfonylurea or insulin

ADD-on to metformin + SULFONYLUREA 
(24 weeks)
PLACEBO
 
JARDIANCE
10 mg
JARDIANCE
25 mg
(n=225)
(n=224)
(n=217)
Overall (plasma glucose ≤70 mg/dL)
8.4%
16.1%
11.5%
Severe (requiring assistance regardless of blood glucose)
0%
0%
0%
add-on to BASAL insulin ± ORALS‡§ 
(18 weeks)
 
PLACEBO
 
JARDIANCE
10 mg
JARDIANCE
25 mg
 
(n=170)
(n=169)
(n=155)
Overall (plasma glucose ≤70 mg/dL)
20.6%
19.5%
28.4%
Severe (requiring assistance regardless of blood glucose)
0%
0%
1.3%

A lower dose of insulin or insulin secretagogues (eg, sulfonylureas) may be required to reduce the risk of hypoglycemia when JARDIANCE is used in combination with these agents

STUDY DESIGNS

JARDIANCE CV Outcome Trial Design: A randomized, double-blind, parallel-group trial comparing the risk of experiencing a major adverse cardiovascular event between JARDIANCE and placebo when these were added to and used concomitantly with standard of care treatments for type 2 diabetes and cardiovascular disease. A total of 7020 patients were treated (JARDIANCE 10 mg [N=2345]; JARDIANCE 25 mg [N=2342]; placebo [N=2333]) and followed for a median of 3.1 years. All patients had established atherosclerotic cardiovascular disease at baseline, including one or more of the following: a documented history of coronary artery disease, peripheral artery disease, myocardial infarction, or stroke. The primary outcome was reduction in risk of cardiovascular events, defined by the composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke.

Monotherapy: A Phase III, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study of JARDIANCE (10 mg, 25 mg) administered orally over 24 weeks in drug-naïve patients with type 2 diabetes mellitus and insufficient glycemic control despite diet and exercise. Six hundred seventy-six treated patients received placebo (N=228), JARDIANCE 10 mg (N=224), or JARDIANCE 25 mg (N=224). The primary endpoint was A1C change from baseline. Weight change and blood pressure change from baseline were secondary endpoints.2

Add-on to metformin: A Phase III, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study of JARDIANCE (10 mg, 25 mg) administered orally once daily over 24 weeks in patients with type 2 diabetes mellitus with insufficient glycemic control despite treatment with metformin ≥1500 mg alone. Six hundred thirty-seven treated patients received placebo + metformin (N=207), JARDIANCE 10 mg + metformin (N=217), or JARDIANCE 25 mg + metformin (N=213). The primary endpoint was A1C change from baseline. Weight change and blood pressure change from baseline were secondary endpoints.3

Add-on to metformin + SU: A Phase III, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study of JARDIANCE (10 mg, 25 mg) administered orally once daily over 24 weeks in patients with type 2 diabetes mellitus with insufficient glycemic control despite treatment with metformin ≥1500 mg in combination with an SU. Six hundred sixty-six treated patients received placebo + metformin + SU (N=225), JARDIANCE 10 mg + metformin + SU (N=225), or JARDIANCE 25 mg + metformin + SU (N=216). The primary endpoint was A1C change from baseline. Weight change from baseline was a secondary endpoint.4

Add-on to basal insulin ± orals: A randomized, double-blind, placebo-controlled, parallel-group, safety and efficacy study of JARDIANCE (10 mg, 25 mg) administered orally once daily over 78 weeks in patients with type 2 diabetes mellitus receiving treatment with basal insulin (eg, glargine, detemir, or NPH insulin) with or without concomitant metformin and/or an SU therapy, and insufficient glycemic control. Four hundred ninety-four treated patients received placebo (N=170), JARDIANCE 10 mg (N=169), or JARDIANCE 25 mg (N=155). The primary endpoint was A1C change from baseline after 18 weeks. Weight change from baseline was a secondary endpoint.5

Add-on to pioglitazone ± metformin: A randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety trial of JARDIANCE (10 mg, 25 mg) administered orally once daily over 24 weeks in patients with type 2 diabetes mellitus with insufficient glycemic control despite a background therapy of pioglitazone alone or in combination with metformin ≥1500 mg. Four hundred ninety-eight treated patients received placebo + pioglitazone (N=165), JARDIANCE 10 mg + pioglitazone (N=165), or JARDIANCE 25 mg + pioglitazone (N=168). The primary endpoint was A1C change from baseline. Weight change from baseline was a secondary endpoint.6

*Pooled data from JARDIANCE 10 mg and JARDIANCE 25 mg.1

Adverse events, excluding hypoglycemia, reported in pooled, placebo-controlled clinical studies in ≥2% of patients treated with JARDIANCE and greater than placebo.

Basal insulin study: No insulin adjustment during the first 18 weeks.

§Orals included metformin and/or a sulfonylurea.

AE=adverse event; CV=cardiovascular; SU=sulfonylurea; UTI=urinary tract infection.

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INDICATIONS AND LIMITATIONS OF USE

JARDIANCE is indicated to reduce the risk of cardiovascular (CV) death in adults with type 2 diabetes mellitus and established CV disease.

JARDIANCE is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

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

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS: History of serious hypersensitivity to empagliflozin or any of the excipients in JARDIANCE; severe renal impairment, end-stage renal disease, or dialysis.

IMPORTANT SAFETY INFORMATION (continued)

WARNINGS AND PRECAUTIONS

Hypotension: Empagliflozin causes intravascular volume contraction and symptomatic hypotension may occur. Before initiating JARDIANCE, assess and correct volume status in the elderly, and in patients with renal impairment, low systolic blood pressure, or on diuretics. Monitor for hypotension.

Ketoacidosis: Ketoacidosis, a serious life-threatening condition requiring urgent hospitalization, has been identified in patients with type 1 and type 2 diabetes mellitus receiving SGLT2 inhibitors, including empagliflozin. Fatal cases of ketoacidosis have been reported in patients taking empagliflozin. Patients who present with signs and symptoms of metabolic acidosis should be assessed for ketoacidosis, even if blood glucose levels are less than 250 mg/dL. If suspected, discontinue JARDIANCE, evaluate, and treat promptly. Before initiating JARDIANCE, consider risk factors for ketoacidosis. Patients may require monitoring and temporary discontinuation in situations known to predispose to ketoacidosis.

Acute Kidney Injury and Impairment in Renal Function: Empagliflozin causes intravascular volume contraction and can cause renal impairment. Acute kidney injury requiring hospitalization and dialysis have been identified in patients taking SGLT2 inhibitors, including empagliflozin; some reports involved patients younger than 65 years of age. Before initiating JARDIANCE, consider factors that may predispose patients to acute kidney injury. Consider temporary discontinuation in settings of reduced oral intake or fluid losses. Monitor patients for signs and symptoms of acute kidney injury. If it occurs, discontinue JARDIANCE and treat promptly.

Empagliflozin increases serum creatinine and decreases eGFR. Patients with hypovolemia may be more susceptible to these changes. Before initiating JARDIANCE, evaluate renal function and monitor thereafter. More frequent monitoring is recommended in patients with eGFR <60 mL/min/1.73 m2. Discontinue JARDIANCE in patients with a persistent eGFR <45 mL/min/1.73 m2.

Urosepsis and Pyelonephritis: Serious urinary tract infections including urosepsis and pyelonephritis requiring hospitalization have been identified in patients receiving SGLT2 inhibitors, including empagliflozin. Treatment with SGLT2 inhibitors increases the risk for urinary tract infections. Evaluate for signs and symptoms of urinary tract infections and treat promptly.

Hypoglycemia: The use of JARDIANCE in combination with insulin or insulin secretagogues can increase the risk of hypoglycemia. A lower dose of insulin or the insulin secretagogue may be required.

Genital Mycotic Infections: Empagliflozin increases the risk for genital mycotic infections, especially in patients with prior infections. Monitor and treat as appropriate.

Hypersensitivity Reactions: Discontinue JARDIANCE, treat promptly, and monitor until signs and symptoms resolve.

Increased Low-Density Lipoprotein Cholesterol (LDL-C): Monitor and treat as appropriate.

MOST COMMON ADVERSE REACTIONS (≥5%): Urinary tract infections and female genital mycotic infections.

DRUG INTERACTIONS: Coadministration with diuretics may enhance the potential for volume depletion.

USE IN SPECIAL POPULATIONS

Pregnancy: JARDIANCE is not recommended, especially during the second and third trimesters.

Lactation: JARDIANCE is not recommended while breastfeeding.

Geriatric Use: JARDIANCE is expected to have diminished efficacy in elderly patients with renal impairment. Renal function should be assessed more frequently in elderly patients. The incidence of volume depletion-related adverse reactions and urinary tract infections increased in patients ≥75 years treated with empagliflozin.

CL-JAR-100004 12.19.17

Please see JARDIANCE Prescribing Information, including Patient Information.