JARDIANCE is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Mechanism of Action Sodium-glucose co-transporter 2 (SGLT2) is the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation. Empagliflozin is an inhibitor of SGLT2. By inhibiting SGLT2, empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.
DOSAGE AND ADMINISTRATION
The recommended dose of JARDIANCE is 10 mg once daily, taken in the morning, with or without food
Dose may be increased to 25 mg once daily
DOSAGE FORMS AND STRENGTHS
Tablets: 10 mg, 25 mg
JARDIANCE (empagliflozin) 10 mg tablets are pale yellow, round, biconvex and bevel-edged, film- coated tablets debossed with “S 10” on one side and the Boehringer Ingelheim company symbol on the other side. JARDIANCE (empagliflozin) 25 mg tablets are pale yellow, oval, biconvex, film-coated tablets debossed with “S 25” on one side and the Boehringer Ingelheim company symbol on the other side.
CONTRAINDICATIONS
-History of serious hypersensitivity reaction to JARDIANCE
-Severe renal impairment, end-stage renal disease, or dialysis
ADVERSE EFFECTS AND PRECAUTIONS
Hypotension
JARDIANCE causes intravascular volume contraction. Symptomatic hypotension may occur after initiating JARDIANCE particularly in patients with renal impairment, the elderly, in patients with low systolic blood pressure, and in patients on diuretics. Before initiating, assess for volume contraction and correct volume status if indicated. Monitor for signs and symptoms of hypotension after initiating therapy and increase monitoring in clinical situations where volume contraction is expected .
Impairment in Renal Function
JARDIANCE increases serum creatinine and decreases eGFR . The risk of impaired renal function with JARDIANCE is increased in elderly patients and patients with moderate renal impairment. More frequent monitoring of renal function is recommended in these patients . Renal function should be evaluated prior to initiating JARDIANCE and periodically thereafter.
Assess renal function before initiating JARDIANCE.
-Do not initiate JARDIANCE if eGFR is below 45 mL/min/1.73 m2. No dose adjustment is needed in patients with an eGFR greater than or equal to 45 mL/min/1.73 m2.
-Discontinue JARDIANCE if eGFR falls persistently below45 mL/min/1.73 m2
Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues
Insulin and insulin secretagogues are known to cause hypoglycemia. The risk of hypoglycemia is increased when JARDIANCE is used in combination with insulin secretagogues (e.g., sulfonylurea) or insulin. Therefore, a lower dose of the insulin secretagogue or insulin may be required to reduce the risk of hypoglycemia when used in combination with JARDIANCE.
Genital Mycotic Infections
JARDIANCE increases the risk for genital mycotic infections . Patients with a history of chronic or recurrent genital mycotic infections were more likely to develop mycotic genital infections.
Urinary Tract Infections
JARDIANCE increases the risk for urinary tract infections.
Diuretics
Coadministration of empagliflozin with diuretics resulted in increased urine volume and frequency of voids, which might enhance the potential for volume depletion
Insulin or Insulin Secretagogues
Coadministration of empagliflozin with insulin or insulin secretagogues increases the risk for hypoglycemia
Positive Urine Glucose Test
Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors as SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests. Use alternative methods to monitor glycemic control.
