Generic Name: saxagliptin (SAX a GLIP tin)
Brand Names: Onglyza

What is Onglyza?

Onglyza (saxagliptin) 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 for people with type 2 diabetes. It is sometimes used in combination with other diabetes medications, but is not for treating type 1 diabetes.

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

Important information

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.

Slideshow: Flashback: FDA Drug Approvals 2013

Before you take Onglyza, 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 with insulin).

To make sure you can safely take Onglyza, tell your doctor if you have:

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

  • pancreatitis;

  • gallstones;

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

  • a history of alcoholism.

FDA pregnancy category B. Onglyza is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

See also: Pregnancy and breastfeeding warnings (in more detail)

It is not known whether saxagliptin passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Onglyza should not be given to a child younger than 18 years old without a doctor's advice.

How should I take Onglyza?

Take Onglyza exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

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

Do not crush, chew, or break a Onglyza tablet. Swallow it whole.

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

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, pale skin, irritability, dizziness, feeling shaky, or trouble concentrating. Always keep a source of sugar with you in case you have low blood sugar. Sugar sources include fruit juice, hard candy, crackers, raisins, and non-diet soda. Be sure your family and close friends know how to help you in an emergency.

If you have severe hypoglycemia and cannot eat or drink, use a glucagon injection. Your doctor can prescribe a glucagon emergency injection kit and tell you how to use it.

Check your blood sugar carefully during times of stress, travel, illness, surgery or medical emergency, vigorous exercise, or if you drink alcohol or skip meals. These things can affect your glucose levels and your dose needs may also change. Do not change your medication dose or schedule without your doctor's advice.

Your doctor may want you to stop taking Onglyza for a short time if you become ill, have a fever or infection, or if you have surgery or a medical emergency.

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.

Store at room temperature away from moisture and heat

What happens if I miss a dose?

Take the missed dose as soon as you remember (be sure to take the medicine with food if your doctor has instructed you to). Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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).

What should I avoid?

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

Onglyza side effects

Get emergency medical help if you have any of these 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.

Call your doctor at once if you have:

  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;

  • pain or burning when you urinate;

  • swelling in your hands, ankles, or feet; or

  • easy bruising or bleeding.

Common Onglyza side effects may include:

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

  • headache.

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.

See also: Side effects (in more detail)

What other drugs will affect Onglyza?

Other drugs may increase or decrease the effects of Onglyza 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.

Where can I get more information?

  • Your pharmacist can provide more information about Onglyza.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Onglyza only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2014 Cerner Multum, Inc. Version: 6.01. Revision Date: 2013-07-16, 2:38:37 PM.

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