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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
Generic Availability
YES
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 and hospitalization for heart failure (HF) in adults with HF (NYHA Class II-IV) with reduced ejection fraction.
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; 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 Pharmacokinetics
See Literature
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
Generic Availability
YES
Farxiga Indications
Indications
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.
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; 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 Pharmacokinetics
See Literature
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
Generic Availability
YES
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; 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 Pharmacokinetics
See Literature
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
