IMPORTANT SAFETY INFORMATION
for ONGLYZA (saxagliptin)
Do not take ONGLYZA (saxagliptin) if you are allergic to any of its ingredients. Serious allergic
reactions can occur with ONGLYZA and may include swelling of the face, lips or throat,
difficulty swallowing or breathing, swelling of the skin, hives, rash, itching,
flaking, or peeling. If you have these symptoms, stop taking ONGLYZA and contact
your doctor right away.
Serious side effects can happen to people taking ONGLYZA, including inflammation
of the pancreas (pancreatitis) which may be severe and lead to death. Before taking
ONGLYZA, tell your doctor if you ever had pancreatitis, gallstones, history of alcoholism,
or high triglyceride levels. Stop taking ONGLYZA and contact your doctor right away
if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going
from your abdomen through to your back. The pain may happen with or without vomiting.
These may be symptoms of pancreatitis.
WHAT IS ONGLYZA?
ONGLYZA (saxagliptin) is a prescription medicine used along with diet and exercise to lower blood
sugar in adults with type 2 diabetes.
ONGLYZA should not be used to treat people with type 1 diabetes or diabetic ketoacidosis
(increased ketones in the blood or urine).
If you have had inflammation of the pancreas (pancreatitis), it is not known if
you have a higher chance of getting pancreatitis while taking ONGLYZA.
When ONGLYZA is used with certain other diabetes medicines to treat high blood sugar,
such as a sulfonylurea or insulin, the risk of low blood sugar (hypoglycemia) is
higher. Symptoms of low blood sugar include shaking, hunger, sweating, headache,
rapid heartbeat, change in mood, and change in vision. Follow your doctor’s instructions
for treating low blood sugar.
When ONGLYZA is used with a thiazolidinedione (TZD), such as pioglitazone or rosiglitazone,
to treat high blood sugar, peripheral edema (fluid retention) may become worse.
If you have symptoms of peripheral edema, such as swelling of hands, feet, or ankles,
call your doctor.
The most common side effects with ONGLYZA include upper respiratory tract infection,
urinary tract infection, and headache.
Your doctor should test your blood to measure how well your kidneys are working
before and during treatment with ONGLYZA. You may need a lower dose if your kidneys
are not working well.
Tell your doctor if you start or stop taking other medications, including antibiotics,
antifungals or HIV/AIDS medications, as your doctor may need to change your dose
Tell your doctor if you are pregnant, breast-feeding, or plan to become pregnant
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please click here for Medication Guide, and
click here for US Full Prescribing Information for ONGLYZA (saxagliptin).