Información de la droga para ONGLYZA (saxagliptin) tablets Initial U.S. Approval: 2009 (E.R. Squibb & Sons, L.L.C.): 17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling.

Patients should be informed of the potential risks and benefits of ONGLYZA and of alternative modes of therapy. Patients should also be informed about the importance of adherence to dietary instructions, regular physical activity, periodic blood glucose monitoring and A1C testing, recognition and management of hypoglycemia and hyperglycemia, and assessment of diabetes complications. During periods of stress such as fever, trauma, infection, or surgery, medication requirements may change and patients should be advised to seek medical advice promptly.

Physicians should instruct their patients to read the Patient Package Insert before starting ONGLYZA therapy and to reread it each time the prescription is renewed. Patients should be instructed to inform their doctor or pharmacist if they develop any unusual symptom or if any existing symptom persists or worsens.

Patients should be informed that response to all diabetic therapies should be monitored by periodic measurements of blood glucose and A1C, with a goal of decreasing these levels toward the normal range. A1C is especially useful for evaluating long-term glycemic control. Patients should be informed of the potential need to adjust their dose based on changes in renal function tests over time.

Manufactured by:Bristol-Myers Squibb Company Princeton, NJ 08543 USA

Marketed by:Bristol-Myers Squibb Company Princeton, NJ 08543andAstraZeneca Pharmaceuticals LPWilmington, DE 19850

12563161256317Iss July 2009