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Precautions and Warnings With Crizotinib

Anyone undergoing treatment with crizotinib should be aware of the potentially serious complications this chemotherapy drug may cause, such as liver problems, lung inflammation, or heart rhythm problems. Also, people who have certain medical issues, such as kidney disease, electrolyte imbalances, or heart problems, should be aware that the safety precautions and warnings with crizotinib may prevent them from using this medicine.

What Should I Tell My Healthcare Provider?

You should talk with your healthcare provider prior to taking crizotinib (Xalkori®) 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 Crizotinib Precautions and Warnings

Some warnings and precautions to be aware of prior to taking crizotinib 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 crizotinib treatment.
 
  • Crizotinib 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.
 
  • Crizotinib 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 QT prolongation during crizotinib treatment (see Drug Interactions With Crizotinib).
 
  • Most people who took crizotinib 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 crizotinib. Therefore, do not drive or operate heavy machinery until you know how this medication affects you.
 
  • Crizotinib may react with a number of other medications (see Drug Interactions With Crizotinib).
  • Crizotinib commonly causes the heart rate to slow down. Sometimes, it becomes dangerously slow. In general, crizotinib should not be combined with other medications that slow the heart rate, if at all possible (see Drug Interactions With Crizotinib). If your heart rate becomes dangerously slow while taking this drug, you may have to stop taking it, either temporarily or permanently.
 
  • 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 this medication when pregnant (see Xalkori and Pregnancy).
 
  • It is unknown whether crizotinib 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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