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Safety

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Tykerb (lapatinib) Tablets July 2008


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- July 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

BOXED WARNING

  • WARNING: HEPATOTOXICITY

WARNINGS AND PRECAUTIONS

  • Hepatotoxicity
  • Patients with Severe Hepatic Impairment

ADVERSE REACTIONS

  • Clinical Trials Experience
    • Hepatotoxicity

USE IN SPECIFIC POPULATIONS

  • Hepatic Impairment

PATIENT PACKAGE INSERT

  • Before you start taking Tykerb, tell your doctor about all of your medical conditions, including if you...
    • have liver problems. You may need a lower dose of Tykerb.
  • What are the possible side effects of Tykerb?
    • Serious side effects include...
      • liver problems, which may cause itching, yellow eyes or skin, dark urine, or pain or discomfort in the right upper area of the belly.
      • Your doctor should do blood tests to check your liver before you start taking Tykerb and during treatment.

BOXED WARNING

WARNING: HEPATOTOXICITY

Hepatotoxicity has been observed in clinical trials and postmarketing experience. The hepatotoxicity may be severe and deaths have been reported. Causality of the deaths is uncertain. [See Warnings and Precautions (5.2).]

WARNINGS AND PRECAUTIONS

Hepatotoxicity

Hepatotoxicity (ALT or AST >3 times the upper limit of normal and total bilirubin >1.5 times the upper limit of normal) has been observed in clinical trials (<1% of patients) and postmarketing experience. The hepatotoxicity may be severe and deaths have been reported. Causality of the deaths is uncertain. The hepatotoxicity may occur days to several months after initiation of treatment. Liver function tests (transaminases, bilirubin, and alkaline phosphatase) should be monitored before initiation of treatment, every 4 to 6 weeks during treatment, and as clinically indicated. If changes in liver function are severe, therapy with Tykerb should be discontinued and patients should not be retreated with Tykerb [see Adverse Reactions (6.1)].

Patients with Severe Hepatic Impairment

...In patients who develop severe hepatotoxicity while on therapy, Tykerb should be discontinued and patients should not be retreated with Tykerb [see Warnings and Precautions (5.2)]
    
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