New Drug Update 2009-2010 - LAFP
New Drug Update 2009-2010 - LAFP
New Drug Update 2009-2010 - LAFP
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exposure, but no change in exposure to the active metabolite or in DPP-4 activity inhibition. Saxagliptin<br />
dosage adjustments are not necessary.<br />
Clinically important pharmacokinetic interactions have not been observed between saxagliptin and<br />
digoxin, metformin, glyburide, pioglitazone, or simvastatin. Coadministration of saxagliptin with<br />
magnesium and aluminum hydroxides plus simethicone, famotidine, or omeprazole did not alter the<br />
pharmacokinetics of saxagliptin or its active metabolite.<br />
DOSING: The recommended dosage is 2.5 or 5 mg once daily taken regardless of meals. The 2.5 mg<br />
daily dosage is recommended for patients with moderate or severe renal impairment, or end-stage renal<br />
disease (creatinine clearance [CrCl] 50 mL/min or less), and for patients also taking strong CYP3A4/5<br />
inhibitors (eg, ketoconazole). For patients with end-stage renal disease undergoing hemodialysis,<br />
saxagliptin should be administered following hemodialysis. Saxagliptin has not been studied in patients<br />
undergoing peritoneal dialysis.<br />
Usual dose<br />
Dose in special populations<br />
Renal<br />
impairment<br />
Hepatic<br />
impairment<br />
Table 8. Dosing Recommendations for Saxagliptin and Sitagliptin<br />
Saxagliptin<br />
2.5 to 5 mg once daily<br />
with or without food<br />
2.5 mg once daily<br />
if CrCl ≤ 50 mL/min<br />
No dosage adjustment<br />
Sitagliptin<br />
100 mg once daily with or without food<br />
50 mg once daily if CrCl 30 to 50 mL/min,<br />
25 mg once daily if CrCl < 30 mL/min<br />
No dosage adjustment<br />
Elderly No dosage adjustment No dosage adjustment<br />
<strong>Drug</strong><br />
interactions<br />
2.5 mg once daily if on potent<br />
CYP3A4/5 inhibitor<br />
No dosage adjustment<br />
PRODUCT AVAILABILITY/COST and STORAGE: Saxagliptin received FDA approval on July 31, <strong>2009</strong>.<br />
It is available as 2.5 and 5 mg tablets. The 5 mg tablets are supplied in bottles of 30, 90, and 500, as well<br />
as a unit-dose blister package of 100 tablets; the 2.5 mg tablets are supplied in bottles of 30 and 90.<br />
Onglyza costs $189.98/30 tabs in either strength and Januvia costs $193.58/30 100mg tabs on<br />
drugstore.com. Saxagliptin tablets should be stored at room temperature (20° to 25°C; 68° to 77°F), with<br />
excursions permitted between 15° and 30°C (59° and 86°F).<br />
Table 9. Available Dosage Forms and Packaging for Saxagliptin and Sitagliptin<br />
Saxagliptin<br />
Onglyza<br />
2.5 mg tablets (30s and 90s)<br />
5 mg tablets (30s, 90s, 500s, and<br />
UD a 100s)<br />
a UD = unit-dose.<br />
Sitagliptin<br />
Januvia<br />
25 mg tablets (30s, 90s, and UD 100s)<br />
50 mg tablets (30s, 90s, and UD 100s)<br />
100 mg tablets (30s, 90s, 500s, 1,000s, and UD 100s)<br />
Janumet<br />
Sitagliptin 50 mg/metformin hydrochloride 500 mg (60s, 180s,<br />
1,000s, and UD 50s)<br />
Sitagliptin 50 mg/metformin hydrochloride 1,000 mg (60s, 180s,<br />
1,000s, and UD 50s)<br />
CONCLUSION: Saxagliptin is an alternative to sitagliptin for the treatment of patients with type 2<br />
diabetes. It is intended to be used as an adjunct to diet and exercise to improve glycemic control in adults<br />
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