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FARXIGA (DAPAGLIFLOZIN): PRESCRIBING INFORMATION
Dapagliflozin is described chemically as D-glucitol, 1,5-anhydro-1-C-[4-chloro-3-[(4ethoxyphenyl)methyl]phenyl]-, (1S)-, compounded with (2S)-1,2-propanediol, hydrate (1:1:1).
The empirical formula is C21H25ClO6 x C3H8O2 x H2O
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, silicon dioxide, crospovidone, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc, and yellow iron oxide.
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.
DOSAGE AND ADMINISTRATION
Farxiga dosage and administration
DOSAGE FORMS AND STRENGTHS
Farxiga (Dapagliflozin Propanediol Monohydrate) 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.
History of a serious hypersensitivity reaction to Farxiga (Dapagliflozin).
Severe renal impairment, end-stage renal disease (ESRD), or patients on dialysis.
Farxiga clinical pharmacology
Farxiga nonclinical toxicology
Overview of Clinical Studies of Farxiga (Dapagliflozin) for Type 2 Diabetes
Farxiga has been studied as monotherapy and in combination with metformin, glimepiride, pioglitazone, sitagliptin (with or without metformin), or insulin (with or without other oral antidiabetic therapy). The efficacy of Farxiga (Dapagliflozin) tablets was compared to a sulfonylurea (glipizide) added on to metformin. This medication has also been studied in patients with type 2 diabetes and moderate renal impairment.
Treatment with Dapagliflozin (Farxiga) as monotherapy and in combination with glimepiride, metformin, pioglitazone, sitagliptin, or insulin produced statistically significant improvements in mean change from baseline at Week 24 in HbA1c compared to control. Reductions in HbA1c were seen across subgroups including gender, age, race, duration of disease, and baseline BMI.
WARNINGS AND PRECAUTIONS
Farxiga warnings and precautions
Farxiga adverse reactions
Positive Urine Glucose Test
Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors such as Farxiga (Dapagliflozin) as SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests. Use alternative methods to monitor glycemic control.
Interference with 1,5-anhydroglucitol (1,5-AG) Assay
Monitoring glycemic control with 1,5-AG assay is not recommended as measurements of 1,5AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control.
USE IN SPECIFIC POPULATIONS
Farxiga use in specific populations
There were no reports of overdose during the clinical development program for Dapagliflozin (Farxiga) tablets.
In the event of an overdose, contact the Poison Control Center. It is also reasonable to employ supportive measures, as dictated by the patient's clinical status. The removal of dapagliflozin by hemodialysis has not been studied.
HOW SUPPLIED / STORAGE AND HANDLING
Farxiga (Dapagliflozin) tablets have markings on both sides and are available in the strengths and packages:
Farxiga 5 mg: yellow, biconvex, round, "5" engraved on one side and "1427" engraved on the other side
Farxiga 10 mg: yellow, biconvex, diamond-shaped, "10" engraved on one side and "1428" engraved on the other side
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).
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