Onglyza may lower blood sugar by helping the body increase the level of insulin after meals.

Onglyza is FDA-approved to be used—along with diet and exercise—alone or in combination with other oral anti-diabetes drugs, including metformin, a sulfonylurea glyburide, or a TZD (thiazolidinedione).

• Onglyza works differently than these drugs, adding Onglyza may help improve control of blood sugar.
• Onglyza has not been studied with insulin.

When Onglyza is used with certain other diabetes medicines to treat high blood sugar, such as a sulfonylurea, low blood sugar (hypoglycemia) may occur. 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.

Before you take Onglyza, tell your doctor about all of your medical conditions, including if you:

• have type 1 diabetes. Onglyza should not be used to treat people with type 1 diabetes.
• have a history of or risk for diabetic ketoacidosis (high levels of certain acids, known as ketones, in the blood or urine). Onglyza should not be used for the treatment of diabetic ketoacidosis.
• have kidney problems, as your doctor may need to adjust your dose of Onglyza.
• are taking insulin. Onglyza has not been studied with insulin.
• are pregnant or plan to become pregnant. It is not known if Onglyza will harm your unborn baby. If you are pregnant, talk with your doctor about the best way to control your blood sugar while you are pregnant.
• are breast-feeding or plan to breast-feed. Onglyza may be passed in your milk to your baby. Talk with your doctor about the best way to feed your baby while you take Onglyza.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.

Onglyza may affect the way other medicines work, and other medicines may affect how Onglyza works. Contact your doctor if you will be starting or stopping certain other types of medications, such as antibiotics, or medicines that treat fungus or HIV/AIDS, because your dose of Onglyza might need to be changed.

Take Onglyza by mouth one time each day exactly as directed by your doctor.

• Onglyza can be taken with or without food.
• During periods of stress on the body, such as fever, trauma, infection, or surgery, contact your doctor right away as your medication needs may change.
• Your doctor should test your blood before starting Onglyza and from time to time to measure how well your kidneys work. You may need a lower dose of Onglyza if your kidneys are not working well.
• Your doctor may prescribe Onglyza along with other medicines that lower blood sugar.
• If you take too much Onglyza, call your doctor or Poison Control Center at 1-800-222-1222, or go to the nearest hospital emergency room right away.

If you miss a dose of Onglyza, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Just take the next dose at your regular time. Do not take two doses at the same time unless your doctor tells you to do so. Talk to your doctor if you have questions about a missed dose.

Most people taking Onglyza did not experience hypoglycemia (very low blood sugar); however, it may occur, particularly when taken with another diabetes medicine, such as a sulfonylurea. Follow your doctor's instructions for treating low blood sugar. Symptoms of low blood sugar include:

• Shaking
• Sweating
• Rapid heartbeat
• Change in vision
• Hunger
• Headache
• Change in mood

If you have symptoms of low blood sugar, you should check your blood sugar and treat if low, then call your healthcare provider.

Low blood sugar (hypoglycemia)) may become worse in people who already take another medication to treat diabetes, such as sulfonylureas. Tell your doctor if you take other diabetes medicines. If you have symptoms of low blood sugar, you should check your blood sugar and treat if low, then call your doctor. Symptoms of low blood sugar include:

• Shaking
• Sweating
• Rapid heartbeat
• Change in vision
• Hunger
• Headache
• Change in mood

If you have allergic (hypersensitivity) reactions, such as rash, hives, and swelling of the face, lips, and throat, stop taking Onglyza and call your healthcare provider right away.

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 healthcare provider. If you do not know whether you are already on this type of medication, ask your healthcare provider.

Common side effects of Onglyza include:

• Upper respiratory tract infection
• Urinary tract infection
• Headache

These are not all of the possible side effects of Onglyza. Tell your doctor if you have any side effects that bother you or that do not go away. For more information, ask your doctor.

In clinical trials, Onglyza did not affect most people's weight.

Store Onglyza between 68° to 77°F (20° to 25°C).
Keep Onglyza and all medicines out of the reach of children.