IMPORTANT SAFETY INFORMATION ( continued ) |
Urosepsis and Pyelonephritis |
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WARNINGS AND PRECAUTIONS ( continued )
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
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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 .
Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues
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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 .
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Insulin and insulin secretagogues are known to cause hypoglycemia . The use of JARDIANCE with these agents can increase the risk of hypoglycemia . A lower dose of insulin or the insulin secretagogue may be required when used in combination with JARDIANCE .
Genital Mycotic Infections
JARDIANCE increases the risk for genital mycotic infections , especially in patients with prior infections . Monitor and treat as appropriate .
Increased Low-Density Lipoprotein
Cholesterol ( LDL-C )
Monitor and treat as appropriate .
ADVERSE REACTIONS
The most common adverse reactions (> 5 %) associated with placebo and JARDIANCE 10 mg and 25 mg were urinary tract infections and female genital mycotic infections .
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