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ONGLYZA (SAXAGLIPTIN): MEDICATION GUIDE

Read this Medication Guide carefully before you start taking Onglyza (Saxagliptin) 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 this medication, ask your healthcare professional.

What is the most important information I should know about Onglyza (Saxagliptin)?

Serious side effects can happen to people taking Onglyza (Saxagliptin HCl), including:

1) 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 (Saxagliptin Hydrochloride) tell your doctor, pharmacist, or other healthcare provider if you have ever had

  • inflammation of your pancreas (pan creatitis)
  • a history of alcoholism
  • stones in your gallbladder (gallstones)
  • high blood triglyceride levels

    It is not known if having these medical problems will make you more likely to get pancreatitis with Onglyza (Saxagliptin Hydrochloride).

    Stop taking Saxagliptin (Onglyza) and contact your doctor or 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 mayhappen with or without vomiting. These may be symptoms of pancreatitis.

    2) Heart failure Before you start taking Saxagliptin HCl (Onglyza) tell your doctor, pharmacist, or other healthcare provider if you
  • have ever had heart failure or have problems with your kidneys.

    Contact your healthcare provider right away if you have any of the following symptoms:

  • increasing shortness of breath or trouble breathing, especially when you lie down
  • an unusually fast increase in weight
  • swelling in the feet, ankles or legs

    These may be symptoms of heart failure

    What is Onglyza?

  • Onglyza (Saxagliptin HCl) lowers blood sugar by helping the body increase the level of insulin after meals.
  • Onglyza (Saxagliptin) is a prescription medicine used with diet and exercise to control high blood sugar (hyperglycemia) in adults with type 2 diabetes.
  • This medicine is unlikely by itself 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. However, hypoglycemia may still occur with Onglyza (Saxagliptin Hydrochloride). Your risk for getting hypoglycemia is higher if you take this medication with some other diabetes medicines, such as a sulfonylurea or insulin.
  • This drug is not for people with diabetic ketoacidosis (increased ketones in your blood or urine).
  • Saxagliptin (Onglyza) is not for people with type 1 diabetes.

    It is not known if Saxagliptin HCl (Onglyza) is safe and effective in children younger than 18 years old.

    Who should not take Saxagliptin Hydrochloride (Onglyza)?

    Do not take Onglyza (Saxagliptin) if you:
  • are allergic to any ingredients in Onglyza (Saxagliptin HCl). See the end of this Medication Guide for a complete list of ingredients in this medication.

    Symptoms of a serious allergic reaction to Onglyza (Saxagliptin HCl) may include:

  • difficulty with swallowing or breathing
  • swelling of your face, lips, throat, and other areas on your skin
  • skin rash, itching, flaking, or peeling
  • raised, red areas on your skin (hives)

    If you have these symptoms, stop taking Onglyza (Saxagliptin Hydrochloride) and contact your physician or healthcare provider right away.

    What should I tell my healthcare provider before taking Onglyza?

    Before you take this drug, tell your physician, pharmacist, or healthcare provider if you:

  • have kidney problems.
  • are pregnant or plan to become pregnant. It is not known if Onglyza (Saxagliptin) 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 (Saxagliptin HCl) 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 this medicine.

    Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter 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. Saxagliptin (Onglyza) may affect the way other medicines work, and other medicines may affect how Onglyza works. Contact your doctor, pharmacist, or other healthcare professional 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 Saxagliptin HCl (Onglyza) might need to be changed.

    How should I take Saxagliptin Hydrochloride (Onglyza)?

  • Onglyza (Saxagliptin) can be taken with or without food.
  • Take this medication by mouth one time each day exactly as directed by your healthcare provider. Do not change your dose without talking to your doctor or pharmacist.
  • Do not split or cut Onglyza tablets.
  • Your pharmacist or other healthcare provider should test your blood to measure how well your kidneys are working before and during your treatment with Onglyza (Saxagliptin HCl). You may need a lower dose of Onglyza (Saxagliptin Hydrochloride) if your kidneys are not working well.
  • During periods of stress on the body, such as fever, trauma, infection, or surgery. Contact your physician or healthcare provider right away as your medication needs may change.
  • Follow your healthcare providerís 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 take too much Saxagliptin HCl (Onglyza), call your doctor, pharmacist, healthcare provider, local poison control center, or go to the nearest hospital emergency room right away.
  • If you miss a dose of Saxagliptin (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.

    What are the possible side effects of Onglyza (Saxagliptin HCl)?

    This drug can cause serious side effects, including:

    Allergic (hypersensitivity) reactions, such as:

  • difficulty with swallowing or breathing
  • swelling of your face, throat, lips, and other areas on your skin
  • raised, red areas on your skin (hives)
  • itching, skin rash, flaking, or peeling

    If you have these symptoms, stop taking Onglyza (Saxagliptin Hydrochloride) and contact your healthcare provider right away.

    Joint pain. Some people who take medicines called DPP-4 inhibitors like Saxagliptin (Onglyza), may develop joint pain that can be severe. Call your physician, pharmacist, or other healthcare professional if you have severe joint pain.

    Common side effects of Saxagliptin HCl (Onglyza) include:

  • upper respiratory tract infection
  • urinary tract infection
  • headache

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

  • sweating
  • shaking
  • rapid heartbeat
  • hunger
  • change in vision
  • 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 doctor, pharmacist, or other healthcare provider.

    These are not all of the possible side effects of Saxagliptin Hydrochloride (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 physician or pharmacist for medical advice about side effects. You may report side effects to the FDA.

    How should I store Onglyza?

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

    Keep This medicine and all medications out of the reach of children.

    General information about the use of Onglyza (Saxagliptin HCl)

    Medicines are sometimes prescribed for conditions that are not mentioned in Medication Guides. Do not use Onglyza (Saxagliptin Hydrochloride) 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 har m them. This Medication Guide summarizes the most important information about ONGLYZA. If you would like to know more information about this drug, talk with your healthcare provider. You can ask your doctor, pharmacist, or other healthcare professional for additional information about Saxagliptin (Onglyza) that is written for healthcare professionals.

    What are the ingredients of Saxagliptin HCl (Onglyza)?

    Active ingredient: saxagliptin
    Inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: polyethylene glycol, polyvinyl alcohol, 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.

    Manufactured and distributed by Bristol-Myers Squibb, AstraZeneca pharmaceutical companies and its divisions.

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