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Farxiga

"The U.S. Food and Drug Administration today approved Farxiga (dapaglifozin) tablets to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.

Type 2 diabetes affects about 24 million people and accounts for "...

Farxiga

INDICATIONS

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, and PATIENT 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 m²or 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].

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.

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

Manufactured by: Bristol-Myers Squibb Company Princeton, NJ 08543 USA. Marketed by: Bristol-Myers Squibb Company Princeton, NJ 08543 and AstraZeneca Pharmaceuticals LP Wilmington, DE 19850. Issued: January 2014

Last reviewed on RxList: 1/22/2014
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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