Kombiglyze XR Warnings and Precautions
If you are planning on undergoing a procedure that requires contrast dye, you may need to temporarily stop taking Kombiglyze XR. Warnings and precautions also apply to people with certain medical conditions, such as hepatitis and congestive heart failure, as well as to women who are pregnant or breastfeeding. In addition, let your healthcare provider know if you drink lower-than-normal amounts of liquid.
What Should I Tell My Healthcare Provider?You should talk with your healthcare provider prior to taking Kombiglyze™ XR (saxagliptin/metformin ER) 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.
- Pregnant or thinking of becoming pregnant
Specific Precautions and Warnings With Kombiglyze XR
- Very preliminary data suggests incretin mimetics, such as Kombiglyze XR, 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 Kombiglyze XR 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 Kombiglyze XR (see Metformin and Alcohol).
- Since liver disease (including liver failure and cirrhosis) can increase your risk of lactic acidosis, you should not take Kombiglyze XR 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:
- 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 Kombiglyze XR. 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 Kombiglyze XR, due to the increased risk of lactic acidosis.
- Taking Kombiglyze XR 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, Kombiglyze XR 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. Kombiglyze XR 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 Kombiglyze XR 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).
- Kombiglyze XR can react with certain medications (see Kombiglyze XR Drug Interactions).
- 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 Kombiglyze XR during pregnancy (see Kombiglyze XR and Pregnancy).
- At least one of the active ingredients in Kombiglyze XR 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, Kombiglyze XR 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.