What are the side effects of Xultophy?


Possible thyroid tumors, including cancer

Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rats and mice, liraglutide, one of the components of Xultophy 100/3.6, and medicines that work like liraglutide caused thyroid tumors, including thyroid cancer.

It is not known if Xultophy 100/3.6 will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people. • Do not use Xultophy 100/3.6 if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC), or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Common Side Effects

The most common side effects of Xultophy 100/3.6 include stuffy or runny nose, sore throat, headache, nausea, diarrhea, increased blood levels of lipase, and upper respiratory tract infection. Talk to your healthcare provider about any side effect that bothers you or does not go away.

Stop using Xultophy 100/3.6 and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.

Low blood sugar (hypoglycemia)

Your risk for getting low blood sugar may be higher if you use Xultophy 100/3.6 with another medicine that can cause low blood sugar.

Signs and symptoms of low blood sugar may include:

dizziness or light-headedness
confusion or drowsiness
blurred vision
• slurred speech
• shakiness
• fast heartbeat
anxiety, irritability, or mood changes
• hunger
• feeling jittery

Kidney problems (kidney failure)

Worsening of kidney failure and sudden kidney failure have happened in people with kidney problems and in people without kidney problems, who have taken liraglutide, one of the ingredients in Xultophy 100/3.6.

Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse. Tell your healthcare provider if you have diarrhea, nausea, or vomiting. Drink plenty of fluids to help reduce your risk of dehydration during treatment with Xultophy 100/3.6.

Serious allergic reactions

Stop using Xultophy 100/3.6 and get medical help right away, if you have any symptoms of a serious allergic reaction including:
• fast heartbeat
fainting or feeling dizzy
• swelling of your face, lips, tongue, or throat
• problems breathing or swallowing
• sudden coughing
chest pain or tightness

Gallbladder problems

Gallbladder problems have happened in some people who take liraglutide, an ingredient in Xultophy 100/3.6. Tell your healthcare provider right away if you get symptoms of gallbladder problems which may include:

  • pain in the right or middle upper stomach area
  • fever
  • nausea and vomiting
  • your skin or the white part of your eyes turns yellow

Low potassium in your blood (hypokalemia)

Heart failure

Taking certain diabetes pills called thiazolidinediones or TZDs with Xultophy 100/3.6 may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure, it may get worse while you take TZDs with Xultophy 100/3.6. Your healthcare provider should monitor you closely while you are taking TZDs with Xultophy 100/3.6.

Tell your healthcare provider if you have any new or worse symptoms of heart failure including shortness of breath, tiredness, swelling of your ankles or feet and sudden weight gain. Treatment with TZDs and Xultophy 100/3.6 may need to be adjusted or stopped by your healthcare provider if you have new or worsening heart failure.