These highlights do not include all the information needed to use FARXIGA safely and effectively. See full prescribing information for FARXIGA.
FARXIGA (dapagliflozin) tablets, for oral use
Initial U.S. Approval: 2014
INDICATIONS AND USAGE
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)
Limitation of use:
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Not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis. (1.1)
DOSAGE AND ADMINISTRATION
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The recommended starting dose is 5 mg once daily, taken in the morning, with or without food. (2.1)
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Dose can be increased to 10 mg once daily in patients tolerating FARXIGA who require additional glycemic control. (2.1)
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Assess renal function before initiating FARXIGA. Do not initiate FARXIGA if eGFR is below 60 mL/min/1.73 m 2. (2.2)
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Discontinue FARXIGA if eGFR falls persistently below 60 mL/min/1.73 m 2. (2.2)
DOSAGE FORMS AND STRENGTHS
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Tablets: 5 mg and 10 mg (3)
CONTRAINDICATIONS
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History of serious hypersensitivity reaction to FARXIGA. (4)
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Severe renal impairment, end-stage renal disease, or dialysis. (4)
WARNINGS AND PRECAUTIONS
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Hypotension: Before initiating FARXIGA, assess volume status and correct hypovolemia in the elderly, in patients with renal impairment or low systolic blood pressure, and in patients on diuretics. Monitor for signs and symptoms during therapy. (5.1, 6.1)
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Impairment in renal function: Monitor renal function during therapy. (5.2)
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Hypoglycemia: In patients taking insulin or an insulin secretagogue with FARXIGA, consider a lower dose of insulin or the insulin secretagogue to reduce the risk of hypoglycemia. (5.3)
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Genital mycotic infections: Monitor and treat if indicated. (5.4)
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Increased LDL-C: Monitor and treat per standard of care. (5.5)
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Bladder Cancer: An imbalance in bladder cancers was observed in clinical trials. FARXIGA should not be used in patients with active bladder cancer and should be used with caution in patients with a prior history of bladder cancer. (5.6)
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Macrovascular outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with FARXIGA or any other antidiabetic drug. (5.7)
ADVERSE REACTIONS
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The most common adverse reactions associated with FARXIGA (5% or greater incidence) were female genital mycotic infections, nasopharyngitis, and urinary tract infections. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
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Pregnancy: There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. (8.1)
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Nursing Mothers: Discontinue FARXIGA or discontinue nursing. (8.3)
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Geriatrics: Higher incidence of adverse reactions related to reduced intravascular volume. (5.1, 8.5)
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Renal Impairment: Higher incidence of adverse reactions related to reduced intravascular volume and renal function. (5.2, 6.1, 8.6)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 8/2014
