Jardiance

— THERAPEUTIC CATEGORIES —
  • CHF and arrhythmias
  • Diabetes
  • Miscellaneous urogenital disorders

Jardiance Generic Name & Formulations

General Description

Empagliflozin 10mg, 25mg; tabs.

Pharmacological Class

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

How Supplied

Tabs—30, 90

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

Not Applicable

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 if confirmed. Monitor for resolution of ketoacidosis before restarting. Withhold (at least 3 days), if possible, prior to major surgery or procedures associated with prolonged fasting. Necrotizing fasciitis of the perineum (Fournier's gangrene); discontinue and treat immediately if suspected; use alternative antidiabetic. Increased risk for genital mycotic infections or UTIs; monitor and treat appropriately. Increased risk for lower limb amputations (esp. history of diabetic foot, peripheral vascular disease, prior amputation, diabetes). Monitor for foot infection (including osteomyelitis), new pain or tenderness, sores or ulcers in lower limbs; 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

General Description

Empagliflozin 10mg, 25mg; tabs.

Pharmacological Class

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

How Supplied

Tabs—30, 90

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

Not Applicable

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 if confirmed. Monitor for resolution of ketoacidosis before restarting. Withhold (at least 3 days), if possible, prior to major surgery or procedures associated with prolonged fasting. Necrotizing fasciitis of the perineum (Fournier's gangrene); discontinue and treat immediately if suspected; use alternative antidiabetic. Increased risk for genital mycotic infections or UTIs; monitor and treat appropriately. Increased risk for lower limb amputations (esp. history of diabetic foot, peripheral vascular disease, prior amputation, diabetes). Monitor for foot infection (including osteomyelitis), new pain or tenderness, sores or ulcers in lower limbs; 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

General Description

Empagliflozin 10mg, 25mg; tabs.

Pharmacological Class

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

How Supplied

Tabs—30, 90

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 sustained eGFR decline, end stage kidney disease, cardiovascular death and hospitalization in adults with chronic kidney disease at risk of progression.

Limitations of Use

Not for treating chronic kidney disease in patients with polycystic kidney disease or those requiring or with a recent history of IV immunosuppressive therapy or >45mg of prednisone or equivalent for kidney disease; effectiveness is not expected in these populations.

Jardiance Dosage and Administration

Adult

Take in the AM. 10mg once daily.

Children

Not established.

Jardiance Contraindications

Not Applicable

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 if confirmed. Monitor for resolution of ketoacidosis before restarting. Withhold (at least 3 days), if possible, prior to major surgery or procedures associated with prolonged fasting. Necrotizing fasciitis of the perineum (Fournier's gangrene); discontinue and treat immediately if suspected; use alternative antidiabetic. Increased risk for genital mycotic infections or UTIs; monitor and treat appropriately. Increased risk for lower limb amputations (esp. history of diabetic foot, peripheral vascular disease, prior amputation, diabetes). Monitor for foot infection (including osteomyelitis), new pain or tenderness, sores or ulcers in lower limbs; 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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