拉帕替尼说明书.pdfVIP

DOSAGE FORMS AND STRENGTHS HIGHLIGHTS OF PRESCRIBING INFORMATION 250 mg tablets (3) These highlights do not include all the information needed to use CONTRAINDICATIONS TYKERB safely and effectively. See full prescribing information for Known severe hypersensitivity (e.g., anaphylaxis) to this product or any of its TYKERB. components. (4) TYKERB (lapatinib) tablets WARNINGS AND PRECAUTIONS Initial U.S. Approval: 2007 •Decreases in left ventricular ejection fraction have been reported. Confirm WARNING: HEPATOTOXICITY normal LVEF before starting TYKERB and continue evaluations during See full prescribing information for complete boxed warning. treatment. (5.1) Hepatotoxicity has been observed in clinical trials and postmarketing •Lapatinib has been associated with hepatotoxicity. Monitor liver function tests experience. The hepatotoxicity may be severe and deaths have been before initiation of treatment, every 4 to 6 weeks during treatment, and as reported. Causality of the deaths is uncertain. [See Warnings and clinically indicated. Discontinue and do not restart TYKERB if patients Precautions (5.2).] experience severe changes in liver function tests. (5.2)