ONGLYZA - saxagliptin tablet, film coated 
Physicians Total Care, Inc.


ONGLYZA (on-GLY-zah)

Read this Medication Guide carefully before you start taking ONGLYZA and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment. If you have any questions about ONGLYZA, ask your healthcare provider.

What is the most important information I should know about ONGLYZA?

Serious side effects can happen to people taking ONGLYZA, including inflammation of the pancreas (pancreatitis) which may be severe and lead to death.

Certain medical problems make you more likely to get pancreatitis.

Before you start taking ONGLYZA:

Tell your healthcare provider if you have ever had

It is not known if having these medical problems will make you more likely to get pancreatitis with ONGLYZA.

Stop taking ONGLYZA and contact your healthcare provider right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.

What is ONGLYZA?

It is not known if ONGLYZA is safe and effective in children younger than 18 years old.

Who should not take ONGLYZA?

Do not take ONGLYZA if you:

Symptoms of a serious allergic reaction to ONGLYZA may include:
  • swelling of your face, lips, throat, and other areas on your skin
  • difficulty with swallowing or breathing
  • raised, red areas on your skin (hives)
  • skin rash, itching, flaking, or peeling
If you have these symptoms, stop taking ONGLYZA and contact your healthcare provider right away.

What should I tell my healthcare provider before taking ONGLYZA?

Before you take ONGLYZA, tell your healthcare provider if you:

Tell your healthcare provider 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 healthcare provider 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 healthcare provider 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.

How should I take ONGLYZA?

Contact your healthcare provider right away as your medication needs may change.

What are the possible side effects of ONGLYZA?

ONGLYZA can cause serious side effects, including:

If you have these symptoms, stop taking ONGLYZA and contact your healthcare provider right away.

Common side effects of ONGLYZA include:

Low blood sugar (hypoglycemia) may become worse in people who also take another medication to treat diabetes, such as sulfonylureas or insulin. Tell your healthcare provider 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 healthcare provider. Symptoms of low blood sugar include:

Swelling or fluid retention in your hands, feet, or ankles (peripheral edema) may become worse in people who also take a thiazolidinedione to treat diabetes. If you do not know whether you are already on this type of medication, ask your healthcare provider.

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

Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

How should I store ONGLYZA?

Store ONGLYZA between 68°F and 77°F (20°C and 25°C).

Keep ONGLYZA and all medicines out of the reach of children.

General information about the use of ONGLYZA

Medicines are sometimes prescribed for conditions that are not mentioned in Medication Guides. Do not use ONGLYZA for a condition for which it was not prescribed. Do not give ONGLYZA to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about ONGLYZA. If you would like to know more information about ONGLYZA, talk with your healthcare provider. You can ask your healthcare provider for additional information about ONGLYZA that is written for healthcare professionals. For more information, go to or call 1-800-ONGLYZA.

What are the ingredients of ONGLYZA?

Active ingredient: saxagliptin

Inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc, and iron oxides.

What is type 2 diabetes?

Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should. Your body can also make too much sugar. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems.

The main goal of treating diabetes is to lower your blood sugar so that it is as close to normal as possible.

High blood sugar can be lowered by diet and exercise, and by certain medicines when necessary.

Revised: 1/2012
Physicians Total Care, Inc.