Saxagliptin

WHY is this medicine prescribed?

Saxagliptin is used along with diet and exercise to lower blood sugar levels in patients with type 2 diabetes (condition in which blood sugar is too high because the body does not produce or use insulin normally). Saxagliptin is in a class of medications called dipeptidyl peptidase-4 (DPP-4) inhibitors. It works by increasing the amount of insulin produced by the body after meals.

People who have diabetes and high blood sugar can develop health problems over time.Taking medication(s), making changes (e.g., diet, exercise, quitting smoking) may help to manage your diabetes and improve your health.Talk to your doctor and other healthcare providers about the best way to manage your diabetes.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Saxagliptin comes as a tablet to take by mouth. It is usually taken once a day with or without food. Take saxagliptin at around the same time every day. Follow the directions on your prescription label carefully. Ask your doctor or pharmacist to explain any part you do not understand. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow tablets whole; do not cut, crush, or chew them.

Saxagliptin controls type 2 diabetes but does not cure it. Continue to take saxagliptin even if you feel well. Do not stop taking saxagliptin without talking to your doctor.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with saxagliptin and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

What SPECIAL PRECAUTIONS should I follow?

Before taking saxagliptin,

• tell your doctor and pharmacist if you are allergic to saxagliptin, any other medications, or any of the ingredients in saxagliptin tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking saxagliptin. You doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you drink or have ever drunk large amounts of alcohol, if you have or have ever had pancreatitis (swelling of the pancreas), gallstones, high levels of triglycerides (fatty substances) in your blood, heart failure, diabetic ketoacidosis (a serious condition that may develop if high blood sugar is not treated), or kidney disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking saxagliptin, call your doctor.

• talk to your doctor about what you should do if you get hurt or if you develop a fever or infection. These conditions may affect your blood sugar and the amount of saxagliptin you may need.

What SPECIAL DIETARY instructions should I follow?

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.

What should I do IF I FORGET to take a dose?

Skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

This medication may cause changes in your blood sugar. You should know the symptoms of low and high blood sugar and what to do if you have these symptoms.

Saxagliptin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• sore throat
• headache
• joint pain

Some side effects can be serious. If you experience any of these symptoms, stop taking saxagliptin and call your doctor immediately:

• itching, rash, hives, or peeling skin
• swelling of the face, lips, tongue or throat; difficulty breathing or swallowing; hoarseness
• ongoing pain, that begins in the upper left or middle of the stomach but may spread to the back; vomiting, or loss of appetite
• excessive tiredness; shortness of breath, especially when lying down; swelling of the feet, ankles, or legs; sudden weight gain
• shaking, hunger, sweating, headache, rapid heartbeat, mood changes, and changes in vision

Saxagliptin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

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).

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

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 doctor may also tell you to measure 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.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.