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Tarceva Label Updated After Reports of Liver Failure, Deaths

Sep 23, 2008 | Parker Waichman LLP

Tarceva, a drug used to treat non-small cell lung cancer, pancreatic cancer and several other types of cancer, has been linked to several instances of liver failure and hepatorenal syndrome in some patients taking the drug.
Tarceva, known generically as erlotinib, is in a class of drugs known as epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors. These treatments are designed to block the EGFR protein, believed to play a role in cancer cell growth. Tarceva monotherapy is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen; Tarceva in combination with gemcitabine is indicated for the first-line treatment of patients with locally advanced, unresectable, or metastatic pancreatic cancer.

Today's Tarceva warning was prompted by information obtained from a pharmacokinetic  study in patients with advanced solid tumors and moderate hepatic impairment.  In this study, 10 of the 15 patients died on treatment or within 30 days of the last Tarceva dose. Although 8 of these patients died from progressive disease, one patient died from hepatorenal syndrome and one patient died from rapidly progressing liver failure.

According to the Food & Drug Administration (FDA),  patients with hepatic impairment should be monitored closely during therapy with Tarceva, and dosing should be interrupted or discontinued if changes in liver function are severe.

Several changes have been made to  the Tarceva label to communicate this new safety information.  In the PRECAUTIONS section of the label, sections entitled "Patients with Hepatic Impairment", "Hepatotoxicity" and "Renal Failure" have been updated with relevant information and moved to the WARNINGS section.  The DOSAGE AND ADMINISTRATION section has also been updated.

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