Saxagliptin is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. Saxagliptin is not for treating type 1 diabetes.

Saxagliptin is sometimes used in combination with other diabetes medications.

Saxagliptin may also be used for purposes not listed in this medication guide.

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

Saxagliptin is not for treating type 1 diabetes.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take saxagliptin 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.

Saxagliptin 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 this medicine 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).

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.

Saxagliptin 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).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. It is important to eat a healthy diet, exercise regularly, and lose weight if necessary. This will help to control your diabetes and help saxagliptin work more effectively.

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: 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 saxagliptin 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.

Saxagliptin may cause serious side effects. 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 side effects of saxagliptin 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.

Keep all appointments with your doctor and the laboratory. Your doctor will probably order certain laboratory tests before and during your treatment with saxagliptin to check your body's response to it. Your blood sugar and glycosylated hemoglobin (HbA1c) should be checked regularly to determine your response to saxagliptin. Your doctor may also tell you how to check your response to saxagliptin by measuring your blood or urine sugar levels at home. Follow these directions carefully.

You should always wear a diabetic identification bracelet to be sure you get proper treatment in an emergency.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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