Xalkori Warnings and Precautions

Some people who have a history of heart problems, electrolyte imbalances, or certain allergies may not be able to take Xalkori. Precautions with this chemotherapy drug also include warnings of potential complications that may occur, such as a life-threatening inflammation of the lungs, liver problems, or dangerous heart rhythm problems. Also, women who are pregnant or breastfeeding should talk to their doctor before using this drug.

What Should I Tell My Healthcare Provider?

You should talk with your healthcare provider prior to taking Xalkori® (crizotinib) if you have:
 
  • Liver disease, such as hepatitis, cirrhosis, or liver failure
  • Kidney disease, such as kidney failure
  • Heart problems, such as congestive heart failure
  • A heart condition known as QT prolongation or long QT syndrome
  • An abnormal heartbeat
  • Ever been told you have electrolyte abnormalities (high or low blood salts, such as sodium, potassium, and magnesium)
  • Any allergies, including to foods, dyes, or preservatives.
 
Also, let your healthcare provider know if you are:
 
  • Pregnant or thinking of becoming pregnant
  • Breastfeeding.
 
You should also tell your healthcare provider about all other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.
 

Specific Precautions and Warnings With Xalkori

Some warnings and precautions to be aware of prior to taking Xalkori include the following:
 
  • This medication is only approved for use in people with non-small cell lung cancer caused by a defect in the anaplastic lymphoma kinase (ALK) gene. Your healthcare provider will take a small sample (biopsy) of your lung cancer to determine if you have this abnormal gene before beginning Xalkori treatment.
 
  • Xalkori can cause life-threatening lung inflammation (pneumonitis), especially within the first two months of treatment. Contact your healthcare provider immediately if you are taking this drug and experience new or worsening breathing problems, such as shortness of breath and coughing.
 
  • Xalkori may cause liver problems. Your healthcare provider will monitor your liver function with a blood test at least monthly during treatment. Contact your healthcare provider if you experience signs of liver problems, such as:
 
    • Yellowing of the skin or whites of the eyes (jaundice)
    • Fatigue
    • Pain in the upper-right area of the abdomen (stomach)
    • Nausea
    • Vomiting
    • Dark urine.
 
  • This medication may cause a potentially life-threatening heart rhythm problem known as QT prolongation. Your healthcare provider may monitor the electrical activity of your heart with an electrocardiogram (ECG) if you are at risk for this problem. People with certain heart problems, people who have electrolyte imbalances, and people who take certain other medicines may have an increased risk for this side effect during treatment (see Xalkori Drug Interactions).
  • Xalkori commonly causes the heart rate to slow down. Sometimes, it becomes dangerously slow. In general, Xalkori should not be combined with other medications that slow the heart rate, if at all possible (see Xalkori Drug Interactions). If your heart rate becomes dangerously slow while taking this drug, you may have to stop taking it, either temporarily or permanently.
 
  • Most people who took Xalkori in clinical trials experienced vision problems, especially in the first two weeks of treatment. Vision problems can include blurred vision, sensitivity to light, flashes of light, and "floaters." Contact your healthcare provider if you develop any problems with your vision while taking this medicine.
 
  • You may experience dizziness, fatigue, or vision problems from Xalkori. Therefore, do not drive or operate heavy machinery until you know how this medication affects you.
 
 
  • This product is a pregnancy Category D medication, which means it may harm an unborn child. Talk to your healthcare provider about the risks and benefits of using it when pregnant (see Xalkori and Pregnancy).
 
  • It is unknown whether Xalkori passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the drug (see Xalkori and Breastfeeding).
 
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Xalkori Medication Information

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