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FAQs About KOMBIGLYZE XR

What is the most important information I should know about KOMBIGLYZE XR?

Serious side effects can happen in people who take KOMBIGLYZE XR, including:

1. Lactic acidosis. Metformin, one of the medicines in KOMBIGLYZE XR, can cause a rare, but serious, condition called lactic acidosis (a build-up of an acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the hospital.

Call your doctor right away if you have any of the following symptoms, which could be signs of lactic acidosis: feel cold in your hands or feet, feel dizzy or lightheaded, have a slow or irregular heartbeat, feel very weak or tired, have unusual (not normal) muscle pain, have trouble breathing, feel sleepy or drowsy, or have stomach pains, nausea, or vomiting.

Most people who have had lactic acidosis with metformin have other things that, combined with the metformin, led to the lactic acidosis. Tell your doctor if you have any of the following, because you have a higher chance of getting lactic acidosis if you have severe kidney problems, or your kidneys are affected by certain x-ray tests that use injectable dye, have liver problems, drink alcohol (very often or a lot of alcohol in short-term "binge" drinking), get dehydrated (lose a large amount of body fluids), have surgery, or have a heart attack, severe infection, or stroke.

2. Inflammation of the pancreas (pancreatitis) which may be severe and lead to death. Before taking KOMBIGLYZE XR, tell your doctor if you ever had inflammation of your pancreas (pancreatitis), stones in your gallbladder (gallstones), a history of alcoholism, or high blood triglyceride levels.

Stop taking KOMBIGLYZE XR and contact your doctor 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.

3. Heart failure. Before taking KOMBIGLYZE XR, tell your doctor if you have ever had heart failure or problems with your kidneys. Contact your doctor right away if you have any of the following symptoms of heart failure: increasing shortness of breath or trouble breathing, especially when you lie down; an unusually fast increase in weight; or swelling in the feet, ankles, or legs.

Learn more about the possible side effects of KOMBIGLYZE XR.

What is KOMBIGLYZE XR?

KOMBIGLYZE XR is an oral prescription medicine that contains saxagliptin and metformin extended-release, and is used with diet and exercise to help control high blood sugar in adults with type 2 diabetes.

KOMBIGLYZE XR should not be used to treat people with type 1 diabetes or diabetic ketoacidosis (increased ketones in the blood or urine).

Who should not take KOMBIGLYZE XR?

Do not take KOMBIGLYZE XR if you:

  • Have kidney problems
  • Are allergic to saxagliptin, metformin, or any of the ingredients in KOMBIGLYZE XR. See What are the ingredients of KOMBIGLYZE XR? Symptoms of a serious allergic reaction to KOMBIGLYZE XR 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); or skin rash, itching, flaking, or peeling

See What is the most important information I should know about KOMBIGLYZE XR?

Learn more about how to take KOMBIGLYZE XR.

What should I tell my healthcare provider before taking KOMBIGLYZE XR?

Before you take KOMBIGLYZE XR, tell your healthcare provider if you:

  • Have type 1 diabetes. KOMBIGLYZE XR should not be used to treat type 1 diabetes
  • Have a history or risk of diabetic ketoacidosis (high levels of certain acids, known as ketones, in the blood or urine). KOMBIGLYZE XR should not be used for the treatment of diabetic ketoacidosis
  • Have kidney problems
  • Have liver problems
  • Have heart problems, including congestive heart failure
  • Are older than 80 years. If you are over 80 years old you should not take KOMBIGLYZE XR unless your kidneys have been checked and they are normal
  • Drink alcohol (very often or a lot of alcohol in short-term "binge" drinking)
  • Are going to get an injection of dye or contrast agents for an x-ray procedure or if you are going to have surgery and will not be able to eat or drink much. In these situations, KOMBIGLYZE XR may need to be stopped for a short time. Talk to your healthcare provider about when you should stop KOMBIGLYZE XR, and when you should start KOMBIGLYZE XR again. See What is the most important information I should know about KOMBIGLYZE XR?
  • Have any other medical conditions
  • Are pregnant or plan to become pregnant. It is not known if KOMBIGLYZE XR 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. It is not known if KOMBIGLYZE XR passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby while you take KOMBIGLYZE XR

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your doctor and pharmacist any time you get a new medicine.

KOMBIGLYZE XR may affect the way other medicines work, and other medicines may affect how KOMBIGLYZE XR works.

How should I take KOMBIGLYZE XR?

  • Take KOMBIGLYZE XR exactly as your doctor tells you
  • KOMBIGLYZE XR should be taken with meals to help lessen an upset stomach side effect
  • Swallow KOMBIGLYZE XR whole. Do not crush, cut, or chew KOMBIGLYZE XR
  • You may sometimes pass a soft mass in your stools (bowel movement) that looks like KOMBIGLYZE XR tablets; this is not unusual
  • When your body is under some types of stress, such as fever, trauma (such as a car accident), infection, or surgery, the amount of diabetes medicine that you need may change. Tell your doctor right away if you have any of these problems
  • Your doctor should do blood tests to check how well your kidneys are working before and during your treatment with KOMBIGLYZE XR
  • Your doctor will check your diabetes with regular blood tests, including your blood sugar levels and your hemoglobin A1C
  • Follow your doctor's instructions for treating blood sugar that is too low (hypoglycemia). Talk to your doctor if low blood sugar is a problem for you. See What are the possible side effects of KOMBIGLYZE XR?
  • Check your blood sugar as your doctor tells you to
  • Stay on your prescribed diet and exercise program while taking KOMBIGLYZE XR
  • If you miss a dose of KOMBIGLYZE XR, take your next dose as prescribed unless your doctor tells you differently. Do not take an extra dose the next day
  • If you take too much KOMBIGLYZE XR, call your doctor, local Poison Control Center, or go to the nearest hospital emergency room right away

See more information on Taking KOMBIGLYZE XR.

What are the possible side effects of KOMBIGLYZE XR?

KOMBIGLYZE XR can cause serious side effects, including:

If you have any of these symptoms, stop taking KOMBIGLYZE XR and contact your healthcare provider or go to the nearest hospital emergency room right away.

  • Low blood sugar (hypoglycemia), which 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:
    • Shaking
    • Sweating
    • Rapid heartbeat
    • Change in vision
    • Hunger
    • Headache
    • Change in mood
  • Joint pain. Some people who take medicines called DPP-4 inhibitors, one of the medicines in KOMBIGLYZE XR, may develop joint pain that can be severe. Call your healthcare provider if you have severe joint pain
  • Skin reaction. Some people who take medicines called DPP-4 inhibitors, one of the medicines in KOMBIGLYZE XR, may develop a skin reaction called bullous pemphigoid that can require treatment in a hospital. Tell your healthcare provider right away if you develop blisters or the breakdown of the outer layer of your skin (erosion). Your healthcare provider may tell you to stop taking KOMBIGLYZE XR

Common side effects of KOMBIGLYZE XR include:

  • Upper respiratory tract infection
  • Stuffy or runny nose and sore throat
  • Urinary tract infection
  • Headache
  • Diarrhea
  • Nausea and vomiting

Taking KOMBIGLYZE XR with meals can help lessen the common stomach side effects of metformin. If you have stomach pains, nausea, or vomiting, tell your doctor. Stomach problems that start later during treatment may be a sign of something more serious.

Tell your doctor if you have any side effects that bother you or do not go away.

These are not all of the possible side effects of KOMBIGLYZE XR. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch.

How should I store KOMBIGLYZE XR?

Store KOMBIGLYZE XR between 68⁰F and 77⁰F (20⁰C and 25⁰C).

Keep KOMBIGLYZE XR and all medicines out of the reach of children.

What are the ingredients of KOMBIGLYZE XR?

Active ingredients: saxagliptin and metformin hydrochloride.

Inactive ingredients in each tablet: carboxymethylcellulose sodium, hypromellose 2208, and magnesium stearate.

The 5 mg/500 mg tablet also contains: microcrystalline cellulose and hypromellose 2910.

Tablet film coat contains: polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc, and iron oxides.

How does KOMBIGLYZE XR work to help control blood sugar?

KOMBIGLYZE XR is believed to work in 4 different ways to help control blood sugar.

How KOMBIGLYZE XR works

Learn more about How KOMBIGLYZE XR Works.

Why KOMBIGLYZE XR?

  • With once-a-day dosing, KOMBIGLYZE XR, in addition to diet and exercise, may help improve blood sugar and A1C levels in appropriate adult patients with type 2 diabetes
  • KOMBIGLYZE XR may help you achieve better blood sugar control than diet and exercise alone
  • Decrease in body weight with KOMBIGLYZE XR was similar to that in patients given metformin alone

Lactic acidosis. Metformin, one of the medicines in KOMBIGLYZE XR, can cause a rare, but serious, condition called lactic acidosis (a build-up of an acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the hospital.

Learn more about lactic acidosis, pancreatitis, and possible side effects of KOMBIGLYZE XR.

Remember, it’s always important for you to ask your doctor which medicine is right for you.

A1C is a laboratory test that shows your average blood sugar level over the past 2 to 3 months.

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You may be able to get KOMBIGLYZE XR for as low as $0 a month for as long as your doctor prescribes it.*

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*Subject to eligibility. Restrictions apply. Not available for government-insured patients. Savings subject to monthly limit.

 

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