Farxiga

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

    • Farxiga Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Dapagliflozin 5mg, 10mg; tabs.

    Pharmacological Class

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

    How Supplied

    Tabs—30

    Manufacturer

    AstraZeneca Pharmaceuticals

    Generic Availability

    YES

    Mechanism of Action

    Dapagliflozin inhibits SGLT2 reducing reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. Dapagliflozin also reduces sodium reabsorption and increases the delivery of sodium to the distal tubule. This may influence several physiological functions including, but not restricted to, lowering both pre- and afterload of the heart and downregulation of sympathetic activity.

    Farxiga Indications

    Indications

    To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors. To reduce risk of cardiovascular death, hospitalization for heart failure (HF), and urgent HF visit in adults with HF.

    Farxiga Dosage and Administration

    Adult

    ≥18yrs (eGFR ≥45mL/min/1.73m2): initially 10mg once daily; (eGFR 25–<45mL/min/1.73m2): 10mg once daily; (eGFR <25mL/min/1.73m2): may continue on 10mg once daily.

    Children

    <18yrs: not established.

    Farxiga Contraindications

    Contraindications

    On dialysis.

    Farxiga Boxed Warnings

    Not Applicable

    Farxiga Warnings/Precautions

    Warnings/Precautions

    Assess volume status and renal function prior to initiation. Correct volume depletion before initiating, if needed. Monitor for hypotension and renal function (esp. elderly, patients with renal impairment, or on loop diuretics) 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. Monitor for genital mycotic infections, UTIs; treat if indicated. Severe hepatic impairment. Elderly. Pregnancy (2nd & 3rd trimesters), nursing mothers: not recommended.

    Farxiga Pharmacokinetics

    Absorption

    Maximum plasma concentration is usually attained within 2 hours under fasting state.

    Absolute oral bioavailability after dapagliflozin 10mg: 78%.

    Distribution

    Plasma protein bound: ~91%.

    Metabolism

    UGT1A9.

    Elimination

    Renal (75%), fecal (21%). Half-life: ~12.9 hours.

    Farxiga Interactions

    Interactions

    May need a lower dose of concomitant insulin or insulin secretagogue to reduce risk of hypoglycemia. May antagonize serum lithium concentrations; monitor levels more frequently. Hypotension with concomitant loop diuretics. May cause false (+) urine glucose tests or unreliable measurements of 1,5-AG assay; use alternative methods to monitor glycemic control.

    Farxiga Adverse Reactions

    Adverse Reactions

    Female genital mycotic infections, nasopharyngitis, UTIs (may be serious), back pain, increased urination; volume depletion, acute renal injury, hypersensitivity reactions, ketoacidosis, urosepsis, pyelonephritis.

    Farxiga Clinical Trials

    See Literature

    Farxiga Note

    Not Applicable

    Farxiga Patient Counseling

    See Literature

    Farxiga Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Dapagliflozin 5mg, 10mg; tabs.

    Pharmacological Class

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

    How Supplied

    Tabs—30

    Manufacturer

    AstraZeneca Pharmaceuticals

    Generic Availability

    YES

    Mechanism of Action

    Dapagliflozin inhibits SGLT2 reducing reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. Dapagliflozin also reduces sodium reabsorption and increases the delivery of sodium to the distal tubule. This may influence several physiological functions including, but not restricted to, lowering both pre- and afterload of the heart and downregulation of sympathetic activity.

    Farxiga Indications

    Indications

    Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

    Limitations of Use

    Not for improving glycemic control in patients with type 1 diabetes. Not for improving glycemic control in adults with type 2 diabetes mellitus with an eGFR <45mL/min/1.73 m2.

    Farxiga Dosage and Administration

    Adult

    ≥18yrs (eGFR ≥45mL/min/1.73m2): initially 5mg once daily in the AM to improve glycemic control; may increase to 10mg once daily for additional control.

    Children

    <18yrs: not established.

    Farxiga Contraindications

    Contraindications

    On dialysis.

    Farxiga Boxed Warnings

    Not Applicable

    Farxiga Warnings/Precautions

    Warnings/Precautions

    Assess volume status and renal function prior to initiation. Correct volume depletion before initiating, if needed. Monitor for hypotension and renal function (esp. elderly, patients with renal impairment, or on loop diuretics) 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. Monitor for genital mycotic infections, UTIs; treat if indicated. Severe hepatic impairment. Elderly. Pregnancy (2nd & 3rd trimesters), nursing mothers: not recommended.

    Farxiga Pharmacokinetics

    Absorption

    Maximum plasma concentration is usually attained within 2 hours under fasting state.

    Absolute oral bioavailability after dapagliflozin 10mg: 78%.

    Distribution

    Plasma protein bound: ~91%.

    Metabolism

    UGT1A9.

    Elimination

    Renal (75%), fecal (21%). Half-life: ~12.9 hours.

    Farxiga Interactions

    Interactions

    May need a lower dose of concomitant insulin or insulin secretagogue to reduce risk of hypoglycemia. May antagonize serum lithium concentrations; monitor levels more frequently. Hypotension with concomitant loop diuretics. May cause false (+) urine glucose tests or unreliable measurements of 1,5-AG assay; use alternative methods to monitor glycemic control.

    Farxiga Adverse Reactions

    Adverse Reactions

    Female genital mycotic infections, nasopharyngitis, UTIs (may be serious), back pain, increased urination; volume depletion, acute renal injury, hypersensitivity reactions, ketoacidosis, urosepsis, pyelonephritis.

    Farxiga Clinical Trials

    See Literature

    Farxiga Note

    Not Applicable

    Farxiga Patient Counseling

    See Literature

    Farxiga Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Dapagliflozin 5mg, 10mg; tabs.

    Pharmacological Class

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

    How Supplied

    Tabs—30

    Manufacturer

    AstraZeneca Pharmaceuticals

    Generic Availability

    YES

    Mechanism of Action

    Dapagliflozin inhibits SGLT2 reducing reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. Dapagliflozin also reduces sodium reabsorption and increases the delivery of sodium to the distal tubule. This may influence several physiological functions including, but not restricted to, lowering both pre- and afterload of the heart and downregulation of sympathetic activity.

    Farxiga Indications

    Indications

    To reduce the risk of sustained eGFR decline, end stage kidney disease, cardiovascular death and hospitalization for heart failure 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 immunosuppressive therapy for kidney disease.

    Farxiga Dosage and Administration

    Adult

    ≥18yrs (eGFR ≥45mL/min/1.73m2): initially 10mg once daily; (eGFR 25–<45mL/min/1.73m2): 10mg once daily; (eGFR <25mL/min/1.73m2): may continue on 10mg once daily.

    Children

    <18yrs: not established.

    Farxiga Contraindications

    Contraindications

    On dialysis.

    Farxiga Boxed Warnings

    Not Applicable

    Farxiga Warnings/Precautions

    Warnings/Precautions

    Assess volume status and renal function prior to initiation. Correct volume depletion before initiating, if needed. Monitor for hypotension and renal function (esp. elderly, patients with renal impairment, or on loop diuretics) 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. Monitor for genital mycotic infections, UTIs; treat if indicated. Severe hepatic impairment. Elderly. Pregnancy (2nd & 3rd trimesters), nursing mothers: not recommended.

    Farxiga Pharmacokinetics

    Absorption

    Maximum plasma concentration is usually attained within 2 hours under fasting state.

    Absolute oral bioavailability after dapagliflozin 10mg: 78%.

    Distribution

    Plasma protein bound: ~91%.

    Metabolism

    UGT1A9.

    Elimination

    Renal (75%), fecal (21%). Half-life: ~12.9 hours.

    Farxiga Interactions

    Interactions

    May need a lower dose of concomitant insulin or insulin secretagogue to reduce risk of hypoglycemia. May antagonize serum lithium concentrations; monitor levels more frequently. Hypotension with concomitant loop diuretics. May cause false (+) urine glucose tests or unreliable measurements of 1,5-AG assay; use alternative methods to monitor glycemic control.

    Farxiga Adverse Reactions

    Adverse Reactions

    Female genital mycotic infections, nasopharyngitis, UTIs (may be serious), back pain, increased urination; volume depletion, acute renal injury, hypersensitivity reactions, ketoacidosis, urosepsis, pyelonephritis.

    Farxiga Clinical Trials

    See Literature

    Farxiga Note

    Not Applicable

    Farxiga Patient Counseling

    See Literature

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