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.
Dipeptidyl peptidase-4 (DPP-4) inhibitor.
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.
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