Saxagliptin -A Story of a New Drug

INDICATIONS AND USAGE :
Saxagliptin is a dipeptidyl peptidase-4 inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Important limitations of use:
Should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
Has not been studied in combination with insulin.
DOSAGE AND ADMINISTRATION:
The recommended dose is 2.5 mg or 5 mg once daily taken regardless of meals.
• 2.5 mg daily is recommended for patients with moderate or severe renal impairment, or end-stage renal disease (CrCl  ≤50 mL/min). Assess renalfunction prior to initiation of Saxagliptin and periodically thereafter.
• 2.5 mg daily is recommended for patients also taking strong cytochrome P450 3A4/5 (CYP3A4/5) inhibitors (e.g., ketoconazole).
DOSAGE FORMS AND STRENGTHS :
Tablets: 5 mg and 2.5 mg
ADVERSE REACTIONS:
Adverse reactions reported in ≥5% of patients treated with Saxagliptin and more commonly than in patients treated with placebo are: upper respiratory tract infection, urinary tract infection, and headache.
• Peripheral edema was reported more commonly in patients treated with the combination of Saxagliptin and a thiazolidinedione (TZD) than in patients treated with the combination of placebo and TZD.
• Hypoglycemia was reported more commonly in patients treated with the combination of Saxagliptin and sulfonylurea than in patients treated with the combination of placebo and sulfonylurea.
• Hypersensitivity-related events (e.g., urticaria, facial edema) were reported more commonly in patients treated with Saxagliptin than in patients treated with  placebo.
DRUG INTERACTIONS :
• Coadministration with strong CYP3A4/5 inhibitors (e.g., ketoconazole)significantly increases saxagliptin concentrations. Recommend limiting Saxagliptin dose to 2.5 mg once daily.

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