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JARDIANCE is now approved to reduce the risk of CV death plus hospitalization
for heart failure in adult patients with HFrEF.*



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*Left ventricular ejection fraction (LVEF) 40% or less.
CV=cardiovascular; HFrEF=heart failure with reduced ejection fraction.

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 * Type 2 diabetes

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 * CV death risk reduction

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FOR ADULTS WITH T2D AND ESTABLISHED CVD


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LEARN MORE ABOUT JARDIANCE FOR YOUR PATIENTS:




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THE MOST INITIATED BRANDED T2D TREATMENT*

JARDIANCE is the #1 initiated branded type 2 diabetes treatment.1*

* Among new prescriptions as measured by NBRx (new-to-brand prescriptions)
through 12/2020

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REDUCE THE RISK OF CV DEATH

JARDIANCE reduced the risk of CV death in adults with established CVD and T2D.

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IN ADULT PATIENTS WITH HFrEF*


NOW APPROVED

To reduce the risk of CV death plus hospitalization for heart failure

View Press Release

*Left ventricular ejection fraction (LVEF) 40% or less.

--------------------------------------------------------------------------------

 
CV=cardiovascular; CVD=cardiovascular disease; T2D=type 2 diabetes.


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INDICATIONS AND LIMITATIONS OF USE

INDICATIONS AND LIMITATIONS OF USE

JARDIANCE is indicated:

 * to reduce the risk of cardiovascular death plus hospitalization for heart
   failure in adults with heart failure and reduced ejection fraction.
 * to reduce the risk of cardiovascular death in adults with type 2 diabetes
   mellitus and established cardiovascular disease.
 * as an adjunct to diet and exercise to improve glycemic control in adults with
   type 2 diabetes mellitus.

JARDIANCE is not recommended in patients with type 1 diabetes mellitus. It may
increase their risk of diabetic ketoacidosis.

JARDIANCE is not recommended for use to improve glycemic control in adults with
type 2 diabetes mellitus with an eGFR <30 mL/min/1.73 m2.
JARDIANCE is likely to be ineffective in this setting based upon its mechanism
of action.

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS: Hypersensitivity to empagliflozin or any of the excipients in
JARDIANCE, reactions such as angioedema have occurred; patients on dialysis.

WARNINGS AND PRECAUTIONS

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. For patients who undergo scheduled surgery, consider
temporarily discontinuing JARDIANCE for at least 3 days prior to surgery.

Volume Depletion: Empagliflozin can cause intravascular volume depletion which
may manifest as symptomatic hypotension or acute transient changes in
creatinine. Acute kidney injury requiring hospitalization and dialysis has been
reported in patients with type 2 diabetes receiving SGLT2 inhibitors, including
empagliflozin. Before initiating, assess volume status and renal function in
patients with impaired renal function (eGFR <60 mL/min/1.73 m2), elderly
patients or patients on loop diuretics. In patients with volume depletion,
correct this condition. After initiating, monitor for signs and symptoms of
volume depletion and renal function.

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.

Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene): Serious,
life-threatening cases requiring urgent surgical intervention have occurred in
both females and males. Serious outcomes have included hospitalization, multiple
surgeries, and death. Assess patients presenting with pain or tenderness,
erythema, or swelling in the genital or perineal area, along with fever or
malaise. If suspected, institute prompt treatment and discontinue JARDIANCE.

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

Hypersensitivity Reactions: Serious hypersensitivity reactions have occurred
with JARDIANCE (angioedema). If hypersensitivity reactions occur, discontinue
JARDIANCE, treat promptly, and monitor until signs and symptoms resolve.

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. Monitor for signs and symptoms.

USE IN SPECIAL POPULATIONS

Pregnancy: JARDIANCE is not recommended 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-100092 08.18.2021

Please see JARDIANCE Prescribing Information, including Medication Guide.

REFERENCE

 * 

 1. Data on file. Boehringer Ingelheim Pharmaceuticals, Inc. 2021.

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