Farxiga (Dapagliflozin Propanediol) - Indications and Dosage

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 [see Clinical Studies ].

Limitation of Use

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

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 [see Warnings and Precautions , Use in Specific Populations (8.5, 8.6) , and Patient Counseling Information ].

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 [see Warnings and Precautions and Use in Specific Populations ].

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.

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 14.

Table 14: 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 Bottles of 90 Bottles of 500 Hospital Unit Dose Cartons of 100	0003-1427-11 0003-1427-12 0003-1427-13 0003-1427-14
10 mg	yellow, biconvex, diamond-shaped	“10” engraved on one side and “1428” engraved on the other side	Bottles of 30 Bottles of 90 Bottles of 500 Hospital Unit Dose Cartons of 100	0003-1428-11 0003-1428-12 0003-1428-13 0003-1428-14

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].