dapagliflozin 10 MG Oral Tablet Farxiga
1 INDICATIONS AND USAGE FARXIGA (dapagliflozin) is indicated: • 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. • To reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure. • 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. • As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use • FARXIGA is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [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: • 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) • To reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure. (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) • As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1) Limitations of use: • Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. (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)
AstraZeneca Pharmaceuticals LP
DIAMOND YELLOW 10 1428
10 1428 DIAMOND YELLOW
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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 30 0310-6205-30 Bottles of 90 0310-6205-90 10 mg yellow, biconvex, diamond-shaped “10” engraved on one side and “1428” engraved on the other side Bottles of 30 0310-6210-30 Bottles of 90 0310-6210-90 Hospital Unit Dose Blister Pack: Carton containing 30 tablets (3 blister cards x 10 tablets per card) 0310-6210-39 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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