BETHESDA, MD 08 January 2014—FDA on January 8 approved the marketing of dapagliflozin to improve glycemic control in adults with type 2 diabetes mellitus.
The oral therapy, a selective, reversible sodium–glucose cotransporter 2 inhibitor, is indicated as part of a blood glucose-lowering regimen that includes diet and exercise.
AstraZeneca and Bristol-Myers Squibb Company stated in December that dapagliflozin has been approved for use in 38 countries outside the United States and will be sold as Farxiga in the U.S. market. The companies expect the drug to be available in U.S. pharmacies later this month.
According to FDA, dapagliflozin has been studied as both monotherapy and in combination with metformin, pioglitazone, glimepiride, sitagliptin, and insulin.
for dapagliflozin states that the drug is not intended for the treatment of type 1 diabetes. The use of the drug is contraindicated in patients with diabetic ketoacidosis, moderate or severe kidney impairment, or end-stage renal disease.
According to the labeling, patients with active bladder cancer should not use dapagliflozin because bladder cancer was diagnosed in more than the expected number of clinical trial participants who received the drug.
Dehydration and hypotension may occur while taking dapagliflozin, especially among patients who are elderly, have impaired kidney function, or take diuretics. The labeling states that patients who use the drug should be counseled to have adequate fluid intake.
Hypovolemia should be corrected in patients with the condition before initiating therapy with dapagliflozin.
The most frequently reported adverse events in clinical trial participants treated with dapagliflozin included genital fungal infections and urinary tract infections. Additional information about these and other potential adverse events is provided in an FDA-required Medication Guide that is part of the labeling for dapagliflozin.
The recommended starting dosage of dapagliflozin is 5 mg taken once daily in the morning with or without food. The dosage may be increased to 10 mg/day if the lower dosage does not provide adequate glycemic control.
Dapagliflozin will be supplied as 5- and 10-mg tablets in bottles of 30, 90, or 500 each and in unit dose hospital packs with 100 tablets each.