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U.S. Department of Health and Human Services

Safety

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Xalkori (crizotinib) Capsules

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – February 2012

 

Summary View

 

WARNINGS AND PRECAUTIONS

Hepatotoxicity
  • Drug-induced hepatotoxicity with fatal outcome has occurred. These cases have occurred during Xalkori treatment in less than 1% of patients in clinical trials. Concurrent elevations in ALT greater than 3 times the upper limit of normal and total bilirubin greater than 2 times the upper limit of normal, with normal alkaline phosphatase, occurred in less than 1% of patients in clinical trials…

 

PATIENT COUNSELING INFORMATION

Hepatotoxicity
  • Inform patients that symptoms of weakness, fatigue, anorexia, nausea, vomiting, abdominal pain (especially RUQ abdominal pain), jaundice, dark urine, generalized pruritus, and bleeding diathesis, especially in combination with fever and rash, should be reported immediately
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