Onglyza is an oral diabetes medicine that helps control blood sugar levels. It works by regulating the levels of insulin your body produces after eating.

Onglyza is used together with diet and exercise to improve blood sugar control in adults with type 2 type 2 diabetes mellitus.

Onglyza is not for treating type 1 diabetes.

Onglyza is sometimes used in combination with other diabetes medications.

You should not use Onglyza if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

Onglyza is not for treating type 1 diabetes.

Before you take this medicine, tell your doctor if you have kidney disease or if you are on dialysis.

Onglyza is only part of a complete program of treatment that also includes diet, exercise, weight control, and possibly other medications. It is important to use this medicine regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Before taking this medicine

You should not use Onglyza if you have ever had a severe allergic reaction to saxagliptin, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment).

To make sure Onglyza is safe for you, tell your doctor if you have ever had:

• kidney disease (or if you are on dialysis);

• heart disease;

• pancreatitis;

• gallstones;

• high triglycerides (a type of fat in the blood); or

• alcoholism.

Follow your doctor's instructions about using this medicine if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Onglyza is not approved for use by anyone younger than 18 years old.

Take Onglyza exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

You may take Onglyza with or without food. Follow your doctor's instructions.

Swallow the tablet whole and do not crush, chew, or break it.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Onglyza is only part of a complete treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor's instructions very closely.

Store at room temperature away from moisture and heat

Usual Adult Dose for Diabetes Type 2:

2.5 or 5 mg orally once a day, regardless of meals

Coadministration with strong CYP450 3A4/5 inhibitors: 2.5 mg orally once a day

Use: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes in multiple clinical settings

You should not use Onglyza if you have ever had a severe allergic reaction to saxagliptin, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment).

To make sure Onglyza is safe for you, tell your doctor if you have ever had:

• kidney disease (or if you are on dialysis);

• heart disease;

• pancreatitis;

• gallstones;

• high triglycerides (a type of fat in the blood); or

• alcoholism.

Follow your doctor's instructions about using this medicine if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Onglyza is not approved for use by anyone younger than 18 years old.

Skip the missed dose and take your next dose at the regular time, unless your doctor tells you otherwise. Do not take two doses at one time, and do not take an extra dose the next day.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. You may have signs of low blood sugar, such as extreme weakness, confusion, tremors, sweating, fast heart rate, trouble speaking, nausea, vomiting, rapid breathing, fainting, and seizure (convulsions).

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction to Onglyza: hives, a purple or red skin rash that spreads and causes blistering and peeling; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking Onglyza and call your doctor right away if you have symptoms of pancreatitis: severe pain in your upper stomach spreading to your back, nausea and vomiting, loss of appetite, or fast heartbeats.

Call your doctor at once if you have:

• severe or ongoing pain in your joints;

• pain or burning when you urinate; or

• heart problems - shortness of breath (even while lying down), feeling weak or tired, rapid weight gain, swelling (especially in your feet, legs, or midsection.

Common Onglyza side effects may include:

• painful urination;

• headache;

• runny or stuffy nose, sore throat, cough; or

• swelling in your hands or feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may increase or decrease the effects of saxagliptin on lowering your blood sugar. Tell your doctor about all medications you use. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.