Select therapeutic use:

CHF and arrhythmias:

Indications for: FARXIGA

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 in adults with HF.

Adult Dosage:

≥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 Dosage:

<18yrs: not established.

FARXIGA Contraindications:

On dialysis.

FARXIGA 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; 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. Monitor for genital mycotic infections, UTIs; treat if indicated. Severe hepatic impairment. Elderly. Pregnancy (2nd & 3rd trimesters), nursing mothers: not recommended.

FARXIGA Classification:

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

FARXIGA 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.

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.

Metabolism:

  • UGT1A9.

Drug Elimination:

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

Generic Drug Availability:

YES

How Supplied:

Tabs—30

Diabetes:

Indications for: FARXIGA

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

Limitations of Use:

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

Adult Dosage:

≥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 Dosage:

<18yrs: not established.

FARXIGA Contraindications:

On dialysis.

FARXIGA 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; 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. Monitor for genital mycotic infections, UTIs; treat if indicated. Severe hepatic impairment. Elderly. Pregnancy (2nd & 3rd trimesters), nursing mothers: not recommended.

FARXIGA Classification:

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

FARXIGA 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.

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.

Metabolism:

  • UGT1A9.

Drug Elimination:

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

Generic Drug Availability:

YES

How Supplied:

Tabs—30

Miscellaneous urogenital disorders:

Indications for: FARXIGA

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.

Adult Dosage:

≥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 Dosage:

<18yrs: not established.

FARXIGA Contraindications:

On dialysis.

FARXIGA 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; 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. Monitor for genital mycotic infections, UTIs; treat if indicated. Severe hepatic impairment. Elderly. Pregnancy (2nd & 3rd trimesters), nursing mothers: not recommended.

FARXIGA Classification:

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

FARXIGA 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.

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.

Metabolism:

  • UGT1A9.

Drug Elimination:

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

Generic Drug Availability:

YES

How Supplied:

Tabs—30