Generic Name and Formulations:
Saxagliptin 2.5mg, 5mg; tabs.

Company:
AstraZeneca Pharmaceuticals
Indications for ONGLYZA:
Adjunct to diet and exercise in type 2 diabetes, as monotherapy or combination therapy. Limitations of use: not for treating type 1 diabetes or diabetic ketoacidosis. Not studied in patients with history of pancreatitis.

Adult:
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:
<18yrs: not established.

Contraindications:
History of serious hypersensitivity reactions (eg, anaphylaxis, angioedema, exfolitative skin conditions).

Warnings/Precautions:
Monitor for signs/symptoms of pancreatitis; discontinue if suspected. Monitor renal function before starting therapy and periodically thereafter. History of angioedema to other DPP4 inhibitors. 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.

Pharmacological Class:
Dipeptidyl peptidase-4 inhibitor.

Adverse Reactions:
Upper respiratory tract infection, UTI, headache, abdominal pain, gastroenteritis, vomiting; peripheral edema (with thiazolidinediones); hypoglycemia (with sulfonylureas), hypersensitivity reactions (discontinue if suspected).

How Supplied:
Tabs 2.5mg—30, 90; 5mg—30, 90, 500