dapagliflozin 5 MG Oral Tablet Farxiga
1 INDICATIONS AND USAGE FARXIGA (dapagliflozin) is indicated: • As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. • 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 the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction. • 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 • FARXIGA is not recommended for patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients [see Warnings and Precautions (5.1) ] . • FARXIGA is not recommended for use to improve glycemic control in adults with type 2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m 2 . FARXIGA is likely to be ineffective in this setting based upon its mechanism of action. • FARXIGA is not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of immunosuppressive therapy for kidney disease. FARXIGA is not expected to be effective in these populations . FARXIGA is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated: • As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1) • 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. (1) • To reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure with reduced ejection fraction (NYHA class II-IV). (1) • 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. (1) Limitations of use: • Not for treatment of type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients. (1) • Not recommended for use to improve glycemic control in adults with type 2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m 2 . FARXIGA is likely to be ineffective in this setting based upon its mechanism of action. (1) • Not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of immunosuppressive therapy for the treatment of kidney disease. FARXIGA is not expected to be effective in these populations. (1)
cardinal health
ROUND YELLOW 1427 5
1427 5 ROUND YELLOW
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dapagliflozin 5 MG Oral Tablet Farxiga
cardinal health
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16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied FARXIGA (
DAPAGLIFLOZIN) tablets have markings on both sides and are available in the strengths and packages listed in Table 18. Table 18: FARXIGA Tablet Presentations Tablet Strength film-coated Tablet Color/Shape Tablet Markings Package Size NDC Code 5 mg yellow, biconvex, round “5” engraved on one side and “1427” engraved on the other side Bottles of approximately 1440 Tablets 55154-6932-8 10 mg yellow, biconvex, diamond-shaped “10” engraved on one side and “1428” engraved on the other side Bottles of approximately 840 tablets 55154-6933-8 Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].
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