Product
Onglyza (saxagliptin)
Approval Date
July 31, 2009
Release Date
End of August 2009
Company
Bristol-Myers Squibb
Class
Dipeptidyl peptidase-4 (DPP4) inhibitor.
Indication
Onglyza is indicated as an adjunct to diet and exercise to improve blood sugar (glycemic) control in adults for the treatment of type 2 diabetes mellitus.
Active Ingredient
Saxagliptin
Agency Roster
Blue Diesel
Corbett Worldwide Healthcare
Ferguson
ICC
Quicksilver Science
Physician Outlook
Onglyza (saxagliptin) is the second once-daily oral DPP-IV inhibitor to enter the diabetes market, posing a direct challenge to Januvia. Physicians are likely to be receptive to Onglyza, which is expected to be priced comparably to Januvia, and offers a smaller pill size. Further, expectations are that Onglyza can be administered once daily in combination with metformin, while Janumet (sitagliptin plus metformin) requires twice-daily administration.
—Mary McBride, Associate Vice President, Research, GfK Healthcare
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Source: Wolters Kluwer Pharma Solutions
Recent MM&M Coverage
The Top 75: Blue Diesel
The Top 75: ICC
Adverse Reactions
Upper respiratory tract infection, UTI, headache, GI upset; peripheral edema (with thiazolidinediones); hypoglycemia (with sulfonylureas), hypersensitivity reactions.
Adults
2.5mg or 5mg once daily. Moderate-severe renal impairment or ESRD requiring hemodialysis (CrCl ≤50mL/min), or concomitant strong CYP3A4/5 inhibitors: 2.5mg once daily. Give dose after hemodialysis.
Children
Not recommended.
Precautions
Not for treating type 1 diabetes or diabetic ketoacidosis. Monitor renal function. Pregnancy (Cat.B). Nursing mothers.
Interactions
Potentiated by strong CYP3A4/5 inhibitors (eg, ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin). Concomitant sulfonylurea: may need lower dose of sulfonylurea to reduce risk of hypoglycemia.
