Generic Name and Formulations:
Saxagliptin 2.5mg, 5mg; tabs.
Indications for ONGLYZA:
Adjunct to diet and exercise in type 2 diabetes, as monotherapy or combination therapy.
Limitations Of use:
Not for treatment of type 1 diabetes or diabetic ketoacidosis.
Swallow whole. 2.5mg or 5mg once daily. Moderate or severe renal impairment or ESRD requiring hemodialysis (CrCl ≤50mL/min), or concomitant strong CYP3A4/5 inhibitors: 2.5mg once daily. Give dose after hemodialysis.
<18yrs: not established.
Assess renal function before starting therapy and periodically thereafter. Monitor for signs/symptoms of pancreatitis, serious hypersensitivity reactions, severe joint pain, or bullous pemphigoid; discontinue if suspected or occurs. Consider risks/benefits in patients with known risk factors for heart failure; monitor for signs/symptoms; evaluate and consider discontinuing if develops. History of angioedema to other DPP4 inhibitors. Pregnancy. Nursing mothers.
Potentiated by strong CYP3A4/5 inhibitors (eg, ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin). May need lower dose of concomitant sulfonylurea or insulin to reduce risk of hypoglycemia.
Dipeptidyl peptidase-4 (DPP-4) inhibitor.
Upper respiratory tract infection, UTI, headache, peripheral edema (with thiazolidinediones); hypoglycemia (with sulfonylureas or insulin), hypersensitivity reactions (eg, anaphylaxis, angioedema, exfoliative skin conditions), pancreatitis, heart failure, severe and disabling arthralgia, bullous pemphigoid.
Tabs 2.5mg—30, 90; 5mg—30, 90, 500