Janumet Warnings and Precautions
Before starting treatment with Janumet, warnings and precautions for the drug should be reviewed with a healthcare provider. Janumet may cause lactic acidosis, low blood sugar, and decreased vitamin B12 levels. Janumet warnings and precautions also extend to those who are allergic to any components of the drug, have metabolic or diabetic ketoacidosis, have kidney disease, or are about to have an x-ray procedure with contrast dye.
You should talk with your healthcare provider prior to taking Janumet® (sitagliptin and metformin) if you have:
- Kidney problems, including kidney failure (renal failure)
- Liver problems, including liver failure or cirrhosis
- Low vitamin B12 levels (pernicious anemia)
- Congestive heart failure (CHF)
- A history of heart attack or stroke
- A history of pancreatitis (inflammation or infection of the pancreas)
- An upcoming surgery or procedure (including x-rays and other radiology procedures)
- Any allergies, including allergies to foods, dyes, or preservatives.
Also, let your healthcare provider know if you are:
- Pregnant or thinking of becoming pregnant
Tell your healthcare provider about all other medicines you are currently taking, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Precautions and warnings to be aware of prior to taking Janumet include the following:
- Very preliminary data suggests incretin mimetics, such as Janumet, 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.
- There have been some reports of pancreatitis in people taking sitagliptin (one of the components of Janumet). 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 pain that sometimes radiates to the back.
- In rare cases, the metformin component of Janumet 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 (see Metformin and Lactic Acidosis).
- Drinking alcohol can increase your risk of lactic acidosis during treatment with Janumet. 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 the drug (see Metformin and Alcohol).
- Since liver disease (including liver failure and cirrhosis) can increase your risk of lactic acidosis, you should not take Janumet if your liver is not functioning normally.
- Your kidney function needs to be monitored while you are taking Janumet. This means that you should have blood tests to check your kidneys before you start treatment and then again at least once every year. If your kidney function is poor, you should not take Janumet, due to the increased risk of lactic acidosis.
- Taking Janumet 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). Also, Janumet should be temporarily stopped for most major surgeries and 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. Janumet 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 (see Janumet and Blood Sugar).
- 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 (loss of water in your body). You may need to stop taking Janumet temporarily during these times.
- Janumet 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).
- Janumet can interact with certain medications (see Janumet Drug Interactions).
- Janumet 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 the medication while pregnant (see Janumet and Pregnancy).
- It is not known if Janumet passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider before using Janumet (see Janumet and Breastfeeding).
- In rare cases, Janumet can cause low blood sugar (hypoglycemia), usually when the drug is 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. Symptoms of low blood sugar include irritability, trembling, cold sweats, or blurry vision, among other things (see Janumet and Blood Sugar).