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Patient Information for Onglyza™ (saxagliptin)
Read the Patient Information that comes with Onglyza (saxagliptin) before you start taking it and each time you
get a refill. There may be new information. Reading this information does not take the place of talking with
your healthcare provider about your medical condition or treatment.
What is Onglyza?
Onglyza is a prescription medicine used with diet and exercise to control high
blood sugar (hyperglycemia) in adults with type 2 diabetes.
Onglyza lowers blood sugar by helping the body increase the level of insulin after meals.
Onglyza is unlikely to cause your blood sugar to be lowered to a dangerous level (hypoglycemia) because it does not work well when your blood sugar is low.
Onglyza has not been studied in children younger than 18 years old.
What should I tell my healthcare provider before taking Onglyza?
Before you take Onglyza, tell your healthcare provider about all of your
medical conditions, including if you:
- have type 1 diabetes. Onglyza should not be used to treat people with type 1 diabetes.
- have a history or risk for diabetic ketoacidosis (high levels of certain acids, known as ketones, in the blood or urine).
Onglyza should not be used for the treatment of diabetic ketoacidosis.
- are taking insulin. Onglyza has not been studied with insulin.
- are pregnant or plan to become pregnant. It is not known if Onglyza will harm your unborn baby.
If you are pregnant, talk with your healthcare provider about the best way to control your blood sugar while
you are pregnant.
- are breast-feeding or plan to breast-feed. Onglyza may be passed in your milk to your baby.
Talk with your healthcare provider about the best way to feed your baby while you take Onglyza.
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?
- Take Onglyza by mouth one time each day exactly as directed by your healthcare provider. Do not change your dose without talking to your healthcare provider.
- Onglyza can be taken with or without food.
- During periods of stress on the body, such as:
- fever
- trauma
- infection
- surgery
Contact your healthcare provider right away as your medication needs may change.
- Your healthcare provider should test your blood to measure how well your kidneys work.
You may need a lower dose of Onglyza if your kidneys are not working well.
- Your healthcare provider may prescribe Onglyza along with other medicines that lower blood sugar.
- Follow your healthcare provider's instructions for treating blood sugar that is too low (hypoglycemia). Talk to your healthcare provider if
low blood sugar is a problem for you.
- If you miss a dose of Onglyza, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose.
Just take the next dose at your regular time. Do not take two doses at the same time unless your healthcare provider tells you to do so.
Talk to your healthcare provider if you have questions about a missed dose.
- If you take too much Onglyza, call your healthcare provider or Poison Control Center at
1-800-222-1222, or go to the
nearest hospital emergency room right away.
What are the possible side effects of Onglyza?
Common side effects of Onglyza include:
- upper respiratory tract infection
Low blood sugar (hypoglycemia) may become worse in people who already take another
medication to treat diabetes, such as sulfonylureas. 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:
- shaking
- sweating
- rapid heartbeat
- change in vision
- hunger
- headache
- change in mood
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.
Allergic (hypersensitivity) reactions, such as rash, hives, and swelling of the face, lips, and throat. If you have these symptoms, stop taking Onglyza and call your healthcare provider right away.
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° to 77°F (20° to 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 the patient information. 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
patient leaflet 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, 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 to a normal level.
High blood sugar can be lowered by diet and exercise, and by certain medicines when necessary.
Please see
US Full Prescribing Information, including
Patient Information for Onglyza (saxagliptin) and discuss with your doctor.
Onglyza is one of several treatment options your doctor may consider.
You are encouraged to report negative side effects of prescription drugs to the FDA.