FARXIGA™

Warnings

Description

Clinical pharmacology

Indications and usage

Contraindications

Precautions

Adverse reactions

Dosage and administration

How supplied

Warnings

See warnings and precautions below.

Description

Description:
Dapagliflozin is described chemically as D-glucitol, 1,5-anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1S)-, compounded with (2S)-1,2-propanediol, hydrate (1:1:1). The empirical formula is C21H25ClO6•C3H8O2•H2O and the molecular weight is 502.98.
FARXIGA is available as a film-coated tablet for oral administration containing the equivalent of 5 mg dapagliflozin as dapagliflozin propanediol or the equivalent of 10 mg dapagliflozin as dapagliflozin propanediol, and the following inactive ingredients: microcrystalline cellulose, anhydrous lactose, crospovidone, silicon dioxide, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and yellow iron oxide.

Clinical pharmacology

Mechanism of Action:
Sodium-glucose cotransporter 2 (SGLT2), expressed in the proximal renal tubules, is responsible for the majority of the reabsorption of filtered glucose from the tubular lumen. Dapagliflozin is an inhibitor of SGLT2. By inhibiting SGLT2, dapagliflozin reduces reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.

Indications and usage

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.

Limitation of Use
FARXIGA is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

USE IN SPECIFIC POPULATIONS
•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.
•Nursing Mothers: Discontinue FARXIGA or discontinue nursing.
•Geriatrics: Higher incidence of adverse reactions related to reduced intravascular volume.
•Renal Impairment: Higher incidence of adverse reactions related to reduced intravascular volume and renal function.

See PACKAGE INSERT for PATIENT COUNSELING INFORMATION and Medication Guide.

Contraindications

Contraindications:
History of serious hypersensitivity reaction to FARXIGA.
Severe renal impairment, end-stage renal disease, or dialysis.

Precautions

WARNINGS AND PRECAUTIONS:

•Hypotension: Before initiating FARXIGA, assess volume status and correct hypovolemia in elderly, in patients with renal impairment or low systolic blood pressure, and in patients on diuretics. Monitor for signs and symtoms during therapy.
•Impairment in renal function: Monitor renal function during therapy.
•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.
•Genital mycotic infections: Monitor and treat if indicated.
•Increased LDL-C: Monitor and treat per standard of care.
•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.
•Macrovascular outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with FARXIGA or any other antidiabetic drug.

Adverse reactions

ADVERSE REACTIONS:
The most common adverse reactions associated with FARXIGA (5% or greater incidence) were female genital mycotic infections, nasopharyngitis, and urinary tract infections.

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.

Dosage and administration

DOSAGE AND ADMINISTRATION:
Recommended Dosing
The recommended starting dose of FARXIGA is 5 mg once daily, taken in the morning, with or without food. In patients tolerating FARXIGA 5 mg once daily who require additional glycemic control, the dose can be increased to 10 mg once daily.

In patients with volume depletion, correcting this condition prior to initiation of FARXIGA is recommended.

Patients with Renal Impairment------------------
Assessment of renal function is recommended prior to initiation of FARXIGA therapy and periodically thereafter.

FARXIGA should not be initiated in patients with an eGFR less than 60 mL/min/1.73 m2.
No dose adjustment is needed in patients with mild renal impairment (eGFR of 60 mL/min/1.73 m2 or greater).
FARXIGA should be discontinued when eGFR is persistently less than 60 mL/min/1.73 m2

How supplied

DOSAGE FORMS AND STRENGTHS:

•FARXIGA 5 mg tablets are yellow, biconvex, round, film-coated tablets with “5” engraved on one side and “1427” engraved on the other side.
•FARXIGA 10 mg tablets are yellow, biconvex, diamond-shaped, film-coated tablets with “10” engraved on one side and “1428” engraved on the other side.

Reference(s)

National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Please review the latest applicable package insert for additional information and possible updates. A local search option of this data can be found here.