Jardiance

— THERAPEUTIC CATEGORIES —
  • CHF and arrhythmias
  • Diabetes
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Jardiance Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Empagliflozin 10mg, 25mg; tabs.

    Pharmacological Class

    Sodium-glucose co-transporter 2 (SGLT2) inhibitor.

    How Supplied

    Tabs—30, 90

    Manufacturer

    Boehringer Ingelheim and Lilly

    Generic Availability

    NO

    Mechanism of Action

    Empagliflozin inhibits SGLT2 reducing renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.

    Jardiance Indications

    Indications

    To reduce the risk of cardiovascular death and hospitalization for heart failure (HF) in adults with HF. To reduce the risk of cardiovascular (CV) death in adults with T2DM and established CV disease.

    Jardiance Dosage and Administration

    Adult

    Take in the AM. 10mg once daily. Insufficient data for dosing: in those who have T2DM and established CV disease (with eGFR <30mL/min/1.73m2), or those who have HF (with eGFR <20mL/min/1.73m2).

    Children

    Not established.

    Jardiance Contraindications

    Contraindications

    Patients on dialysis.

    Jardiance Boxed Warnings

    Not Applicable

    Jardiance Warnings/Precautions

    Warnings/Precautions

    Correct volume depletion before initiating. Increased risk for volume depletion or hypotension in those with renal impairment (eGFR <60mL/min/1.73m2), elderly, or on loop diuretics. Assess volume status and renal function prior to initiation; monitor during therapy. Assess for ketoacidosis in presence of signs/symptoms of metabolic acidosis, regardless of blood glucose levels; discontinue if suspected, evaluate and treat; consider risk factors before initiation (eg, pancreatic insulin deficiency, caloric restriction, alcohol abuse). Consider temporarily discontinuing prior to scheduled surgery (for ≥3 days) or other clinical situations (eg, prolonged fasting due to illness or post-surgery). Necrotizing fasciitis of the perineum (Fournier's gangrene); discontinue and treat immediately if suspected; use alternative antidiabetic. Increased risk of genital mycotic infections or UTIs; monitor and treat appropriately. Discontinue if hypersensitivity reaction occurs; treat promptly and monitor until resolve. Elderly. Pregnancy (during 2nd & 3rd trimesters), nursing mothers: not recommended.

    Jardiance Pharmacokinetics

    Absorption

    • Peak plasma concentration is reached at 1.5 hours post-dose.

    Distribution

    • Apparent steady-state volume of distribution: ~73.8 L.

    • Plasma protein bound: 86.2%.

    Metabolism

    • Glucuronidation by UGT2B7, UGT1A3, UGT1A8, UGT1A9.

    Elimination

    • Renal (54.4%), fecal (41.2%). Half-life: 12.4 hours.

    Jardiance Interactions

    Interactions

    Greater potential for volume depletion with concomitant diuretics. Consider a lower dose of concomitant insulin or insulin secretagogue (eg, sulfonylurea) to reduce risk of hypoglycemia. May antagonize serum lithium concentrations; monitor levels more frequently. May result in false (+) urine glucose tests or unreliable measurements of 1,5-AG assay; use alternative methods to monitor glycemic control.

    Jardiance Adverse Reactions

    Adverse Reactions

    UTIs, female genital mycotic infections, increased urination; hypotension, ketoacidosis, renal impairment, urosepsis, pyelonephritis, angioedema; rare: Fournier's gangrene.

    Jardiance Clinical Trials

    See Literature

    Jardiance Note

    Not Applicable

    Jardiance Patient Counseling

    See Literature

    Jardiance Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Empagliflozin 10mg, 25mg; tabs.

    Pharmacological Class

    Sodium-glucose co-transporter 2 (SGLT2) inhibitor.

    How Supplied

    Tabs—30, 90

    Manufacturer

    Boehringer Ingelheim and Lilly

    Generic Availability

    NO

    Mechanism of Action

    Empagliflozin inhibits SGLT2 reducing renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.

    Jardiance Indications

    Indications

    Adjunct to diet and exercise to improve glycemic control in adults and pediatric patients ≥10yrs with type 2 diabetes mellitus (T2DM). 

    Limitations of Use

    Not recommended in those with type 1 diabetes; may increase risk of diabetic ketoacidosis. Not recommended in adults with T2DM with an eGFR <30mL/min/1.73m2.

    Jardiance Dosage and Administration

    Adults and Children

    <10yrs: not established. Take in the AM. ≥10yrs: Initially 10mg once daily; may increase to 25mg, if tolerated.

    Jardiance Contraindications

    Contraindications

    Patients on dialysis.

    Jardiance Boxed Warnings

    Not Applicable

    Jardiance Warnings/Precautions

    Warnings/Precautions

    Correct volume depletion before initiating. Increased risk for volume depletion or hypotension in those with renal impairment (eGFR <60mL/min/1.73m2), elderly, or on loop diuretics. Assess volume status and renal function prior to initiation; monitor during therapy. Assess for ketoacidosis in presence of signs/symptoms of metabolic acidosis, regardless of blood glucose levels; discontinue if suspected, evaluate and treat; consider risk factors before initiation (eg, pancreatic insulin deficiency, caloric restriction, alcohol abuse). Consider temporarily discontinuing prior to scheduled surgery (for ≥3 days) or other clinical situations (eg, prolonged fasting due to illness or post-surgery). Necrotizing fasciitis of the perineum (Fournier's gangrene); discontinue and treat immediately if suspected; use alternative antidiabetic. Increased risk of genital mycotic infections or UTIs; monitor and treat appropriately. Discontinue if hypersensitivity reaction occurs; treat promptly and monitor until resolve. Elderly. Pregnancy (during 2nd & 3rd trimesters), nursing mothers: not recommended.

    Jardiance Pharmacokinetics

    Absorption

    • Peak plasma concentration is reached at 1.5 hours post-dose.

    Distribution

    • Apparent steady-state volume of distribution: ~73.8 L.

    • Plasma protein bound: 86.2%.

    Metabolism

    • Glucuronidation by UGT2B7, UGT1A3, UGT1A8, UGT1A9.

    Elimination

    • Renal (54.4%), fecal (41.2%). Half-life: 12.4 hours.

    Jardiance Interactions

    Interactions

    Greater potential for volume depletion with concomitant diuretics. Consider a lower dose of concomitant insulin or insulin secretagogue (eg, sulfonylurea) to reduce risk of hypoglycemia. May antagonize serum lithium concentrations; monitor levels more frequently. May result in false (+) urine glucose tests or unreliable measurements of 1,5-AG assay; use alternative methods to monitor glycemic control.

    Jardiance Adverse Reactions

    Adverse Reactions

    UTIs, female genital mycotic infections, increased urination; hypotension, ketoacidosis, renal impairment, urosepsis, pyelonephritis, angioedema; rare: Fournier's gangrene.

    Jardiance Clinical Trials

    See Literature

    Jardiance Note

    Not Applicable

    Jardiance Patient Counseling

    See Literature

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