"The European Medicines Agency (EMA) is alerting doctors and other healthcare professionals to the possibility of atypical cases of diabetic ketoacidosis (DKA) associated with use of sodium-glucose cotransporter-2 (SGLT2) inhibitors, a relatively "...
DOSAGE AND ADMINISTRATION
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.
Patients With Renal Impairment
Assessment of renal function is recommended prior to initiation of FARXIGA therapy and periodically thereafter.
Initiation of FARXIGA is not recommended 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 is contraindicated in patients with an eGFR less than 30 mL/min/1.73 m2 [see CONTRAINDICATIONS].
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.
Storage And Handling
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||0310-620530|
|10 mg||yellow, biconvex, diamond-shaped||“10” engraved on one side and “1428” engraved on the other side||Bottles of 30||0310-621030|
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].
Distributed by: AstraZeneca Pharmaceuticals LP W ilmington, DE 19850. Revised: Aug 2016.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/27/2017
Additional Farxiga Information
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.
Find out what women really need.