Kombiglyze XR

Kombiglyze XR is a prescription medication used to treat type 2 diabetes in adults. Kombiglyze XR is a single tablet containing two prescription drugs, saxagliptin and metformin. Saxagliptin belongs to a group of drugs called dipeptidyl peptidase-4 (DPP-4) inhibitors, which help lower blood sugar levels. Metformin belongs to a group of drugs called biguanides, which decrease the amount of sugar made by the liver and help the body respond to insulin.

This medication comes as extended release tablets and is usually taken once a day, with meals. Swallow the Kombiglyze XR tablets whole. Do not crush, cut, or chew Kombiglyze XR tablets.

Common side effects of Kombiglyze XR include upper respiratory infections, stuffy nose, sore throat, diarrhea, nausea and vomiting.

Kombiglyze XR is a prescription medicine containing saxagliptin and metformin that is used with diet and exercise to help control high blood sugar in adults with type 2 diabetes.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Astrazeneca

• Bristol-Myers Squibb Co.

Kombiglyze XR can cause serious side effects. See "Drug Precautions."

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 Kombiglyze XR. If you have unexplained stomach problems, tell your healthcare provider. Stomach problems that start later during treatment may be a sign of something more serious.

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:

• shaking
• sweating
• rapid heartbeat
• change in vision
• hunger
• headache
• change in mood

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

These are not all of the possible side effects of Kombiglyze XR. For more information, ask your healthcare provider or pharmacist.

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

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Especially tell your doctor if you take medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan (Vaprisol), delavirdine (Rescriptor), and nefazodone.

Tell your healthcare provider if you will be starting or stopping certain other types of medicines, such as antibiotics, or medicines that treat fungus or HIV/AIDS, because your dose of Kombiglyze XR might need to be changed.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Serious side effects can happen in people taking Kombiglyze XR, including:

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

Stop taking Kombiglyze XR and call your healthcare provider right away if you get any of the following symptoms of lactic acidosis:

• feel very weak and tired
• have unusual (not normal) muscle pain
• have trouble breathing
• have unusual sleepiness or sleep longer than usual
• have unexplained stomach or intestinal problems with nausea and vomiting, or diarrhea
• feel cold, especially in your arms and legs
• feel dizzy or lightheaded
• have a slow or irregular heartbeat

You have a higher chance of getting lactic acidosis if you:

• have kidney problems. People whose kidneys are not working properly should not take Kombiglyze XR.
• have liver problems.
• have congestive heart failure that requires treatment with medicines.
• drink a lot of alcohol (very often or short-term “binge” drinking).
• get dehydrated (lose a large amount of body fluids). This can happen if you are sick with a fever, vomiting, or diarrhea. Dehydration can also happen when you sweat a lot with activity or exercise and do not drink enough fluids.
• have certain x-ray tests with injectable dyes or contrast agents.
• have surgery.
• have a heart attack, severe infection, or stroke.
• are 80 years of age or older and have not had your kidney function tested.

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 Kombiglyze XR:

• inflammation of your pancreas (pancreatitis)
• stones in your gallbladder (gallstones)
• a history of alcoholism
• high blood triglyceride levels
• a history of a serious hypersensitivity reaction to Kombiglyze XR, such as anaphylaxis, angioedema, or exfoliative skin conditions

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

Stop taking Kombiglyze XR 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.

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:

• shaking
• sweating
• rapid heartbeat
• change in vision
• hunger
• headache
• change in mood

Kombiglyze XR may cause severe and persistent joint pain. If you experience severe and persistent joint pain, contact your doctor right away. Do not stop taking your medication. Your doctor will decide if your medication is the possible cause of severe  joint pain and will discontinue the drug if appropriate.

Allergic hypersensitivity) reactions. If you have these symptoms, stop taking Kombiglyze XR and contact your healthcare provider right away.

• 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

Do not take Kombiglyze XR if you:

• have a condition called metabolic acidosis or diabetic ketoacidosis (increased ketones in your blood or urine)
• have kidney problems
• have a history of a serious hypersensitivity reaction to Kombiglyze XR, such as anaphylaxis, angioedema, or exfoliative skin conditions

Follow dietary (food) recommendations made by your doctor and dietitian which should include a healthy diet. Skipping meals should be avoided as this can cause problems maintaining blood sugar control. There are no specific foods to avoid while using Kombiglyze XR.

Before you take Kombiglyze XR, tell your healthcare provider about all of your medical conditions and especially if you:

• have type 1 diabetes. Kombiglyze XR should not be used to treat type 1 diabetes.
• have a history or risk for 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 drink 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 will 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.
• 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 breastfeeding or plan to breastfeed. 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 takeKombiglyze XR.

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category B. 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.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. 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.

Take Kombiglyze XR exactly as prescribed.

Kombiglyze XR comes in tablet form and is taken once daily with a meal 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.

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 healthcare provider right away if you have any of these problems.

Your healthcare provider should do blood tests to check how well your kidneys are working before and during your treatment with Kombiglyze XR.

Your healthcare provider will check your diabetes with regular blood tests, including your blood sugar levels and your hemoglobin A1C.

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.

Check your blood sugar as your healthcare provider 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 healthcare provider tells you differently. Do not take an extra dose the next day.

If you take too much Kombiglyze XR, call your healthcare provider, local Poison Control Center, or go to the nearest hospital emergency room right away.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose of Kombiglyze XR will be individualized based on the nature of your diabetes.

The dose your doctor recommends may be based on the following:

• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The maximum daily dose of Kombiglyze XR is 5 mg for saxagliptin and 2000 mg for metformin extended-release.

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

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

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

WARNING: LACTIC ACIDOSIS

Lactic acidosis is a rare, but serious, complication that can occur due to metformin accumulation. The risk increases with conditions such as sepsis, dehydration, excess alcohol intake, hepatic impairment, renal impairment, and acute congestive heart failure.

The onset of lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress.

Laboratory abnormalities include low pH, increased anion gap, and elevated blood lactate.

If acidosis is suspected, saxagliptin/metformin should be discontinued and the patient hospitalized immediately.