FOR ADULTS WITH ESTABLISHED CV DISEASE AND TYPE 2 DIABETES

THE LANDMARK JARDIANCE CV OUTCOME TRIAL

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INDICATION AND LIMITATIONS OF USE

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

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

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS JARDIANCE should not be used in patients with a history of serious hypersensitivity to JARDIANCE or in patients with severe renal impairment , end-stage renal disease , or dialysis .

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

Ketoacidosis Reports of ketoacidosis , a serious lifethreatening condition requiring urgent hospitalization have been identified in patients with type 1 and type 2 diabetes mellitus receiving sodium glucose co transporter 2 ( SGLT2 ) inhibitors , including JARDIANCE . Fatal cases of ketoacidosis have been reported in patients taking JARDIANCE . 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 on JARDIANCE may require monitoring and temporary discontinuation in situations known to predispose to ketoacidosis .

Acute Kidney Injury and Impairment in Renal Function JARDIANCE 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 JARDIANCE ; some reports involved patients younger than 65 years of age . Before initiating JARDIANCE , consider factors that may predispose patients to acute kidney injury including hypovolemia , chronic renal insufficiency , congestive heart failure and concomitant medications ( diuretics , ACE inhibitors , ARBs , NSAIDs ). Consider temporary discontinuation in settings of reduced oral intake or fluid losses .

Monitor patients for signs and symptoms of acute kidney injury . If acute kidney injury occurs , discontinue JARDIANCE promptly and institute treatment .

JARDIANCE increases serum creatinine and decreases eGFR . Patients with hypovolemia may be more susceptible to these changes . Renal function should be evaluated prior to initiating JARDIANCE and periodically thereafter . More frequent monitoring is recommended in patients with eGFR < 60 mL / min / 1.73 m 2 . JARDIANCE should be discontinued in patients with a persistent eGFR < 45 mL / min / 1.73 m 2 .

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

Please see Important Safety Information and Brief Summary of Prescribing Information on adjacent pages .

Reference : 1 . Zinman B , Wanner C , Lachin JM , et al ; EMPA-REG OUTCOME Investigators . N Engl J Med . 2015 ; 373 ( 22 ): 2117-2128 .

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