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Precautions and Warnings With Saxagliptin/Metformin ER

People who have congestive heart failure, liver disease, or kidney failure may be at greater risk for problems with saxagliptin/metformin ER. Warnings and precautions also apply to people who are about to undergo procedures involving contrast dye, as well as those who drink heavily on a regular basis. Women who are pregnant or breastfeeding should discuss their situation with the doctor before taking this drug.

What Should I Tell My Healthcare Provider?

You should talk with your healthcare provider prior to taking saxagliptin/metformin ER (Kombiglyze™ XR) if you have:
 
  • Kidney disease, such as kidney failure (renal failure)
  • Liver disease, such as liver failure, hepatitis, or cirrhosis
  • An alcohol problem
  • An upcoming radiology procedure that will require the use of contrast dye
  • Pernicious anemia
  • Type 1 diabetes
  • Ever had pancreatitis (inflammation or infection of the pancreas
  • Diabetic ketoacidosis
  • Any allergies, including to food, dyes, or preservatives.
     
Also, let your healthcare provider know if you are:
 
  • Pregnant or thinking of becoming pregnant
  • Breastfeeding.
     
Make sure to tell your healthcare provider about all the medicines you take, including prescription and nonprescription medications, vitamins, and herbal supplements.
 

Specific Saxagliptin/Metformin ER Precautions and Warnings

Some warnings and precautions to be aware of prior to taking this drug include the following:
 
  • Very preliminary data suggests incretin mimetics, such as saxagliptin/metformin ER, may increase the risk of precancerous cellular changes (called pancreatic duct metaplasia) in people with type 2 diabetes. Researchers are continuing to study the possibility that incretin mimetics might increase the risk of pancreatic cancer, although at this time there is not enough information to know for sure if there is any increased risk.
 
  • In rare cases, the metformin component of saxagliptin/metformin ER may cause a life-threatening condition called lactic acidosis. Your risk of lactic acidosis increases with other medical conditions, including congestive heart failure (CHF), kidney failure, and liver problems, including liver failure and cirrhosis.

(Click Metformin and Lactic Acidosis for more information, including possible symptoms of lactic acidosis.)

  • Drinking alcohol can increase your risk of lactic acidosis. Drinking large amounts of alcohol on a regular basis or drinking a large amount of alcohol at once (binge drinking) should be avoided while taking saxagliptin/metformin ER (see Metformin and Alcohol).
     
  • Since liver disease (including liver failure and cirrhosis) can increase your risk of lactic acidosis, you should not take saxagliptin/metformin ER if your liver is not functioning normally.

 

  • There have been rare reports of pancreatitis in people taking saxagliptin (one of the components of this medication). Based on reports of this problem with saxagliptin or other similar drugs, this is probably most likely to occur shortly after the drug is first started or when the dosage is increased. Be sure to let your healthcare provider know right away if you have signs of pancreatitis, such as:
     
    • Nausea
    • Vomiting
    • Loss of appetite
    • Severe persistent abdominal (stomach) pain that sometimes radiates to the back. 

 

  • Your kidney function needs to be monitored while you are taking saxagliptin/metformin ER. This means that you should have blood tests to check your kidneys before you start treatment and then at least once every year. If your kidney function is poor, you should not take saxagliptin/metformin ER, due to the increased risk of lactic acidosis.
     
  • Taking saxagliptin/metformin ER and contrast dye at the same time can increase your risk of kidney damage. Contrast dye is used for certain radiology procedures, including some x-rays, CT scans, and heart catheterizations (see Metformin and Contrast Medium for more information).

In addition, saxagliptin/metformin ER should be stopped temporarily for most major surgeries and should be restarted when you are eating normally again.  

  • Fever, infections, injury, or surgery can temporarily increase your blood sugar, even in people with well-controlled diabetes. Saxagliptin/metformin ER may not be enough to treat your diabetes at these times, and the use of insulin may be required.

Contact your healthcare provider if you have a fever, infection, injury, or will be having surgery. Also, make sure you know the symptoms of high blood sugar and how to check your blood sugar levels.  

  • Let your healthcare provider know if you have an illness that causes severe vomiting, diarrhea or fever, or if you drink a much lower amount of liquid than normal. These conditions can lead to severe dehydration. You may need to stop taking saxagliptin/metformin ER for a short time.
     
  • This medication can decrease your levels of vitamin B12. Your healthcare provider should monitor your vitamin B12 levels, especially if you have a vitamin B12 deficiency (including pernicious anemia).
     
  • Saxagliptin/metformin ER can react with certain medications (see Drug Interactions With Saxagliptin/Metformin ER).
     
  • This product is considered a pregnancy Category B medication. This means that it is probably safe for use in pregnant women, although the full risks are not known. Talk to your healthcare provider before taking saxagliptin/metformin ER during pregnancy (see Kombiglyze XR and Pregnancy).
     
  • At least one of the active ingredients in this medication passes through breast milk. Therefore, if you are breastfeeding or plan to start, talk with your healthcare provider before using this drug (see Kombiglyze XR and Breastfeeding for more information).
     
  • In rare cases, saxagliptin/metformin ER can cause low blood sugar (hypoglycemia), usually when combined with other diabetes medications. This has been more common in elderly people and in people with adrenal, pituitary, liver, or kidney problems -- as well as during fasting before surgery and after prolonged exercise. Low blood sugar symptoms may include irritability, trembling, cold sweats, or blurry vision, among other things.
     
Diabetes Tips for Seniors

Saxagliptin/Metformin ER Drug Information

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