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Tarceva Warning in Canada

Dec 19, 2008 | Parker Waichman LLP Canadian health authorities announced important new information today about the use of Tarceva in patients with moderate liver impairment and advanced cancer.  According to Health Canada, a recent study indicated that such patients are more likely to die following treatment with Tarceva.

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.

According to Health Canada, in a study of patients with advanced solid tumors that compared patients with moderate liver impairment and patients with normal liver function, ten of the fifteen patients with hepatic impairment died during treatment or within 30 days of the last Tarceva dose. Two patients died from rapidly progressing liver failure including 1 patient with hepatorenal syndrome. Laboratory findings of hepatic failure and/or renal failure were also observed in at least 4 patients out of the remaining 8 patients. Six out of the 10 patients who died had evidence of severe, rather than moderate liver impairment.   All patients had hepatic impairment due to advanced cancer with liver involvement such as hepatocellular carcinoma, cholangiocarcinoma, or liver metastases.

Health Canada said the Tarceva label will be updated to reflect the risk seen in the study.  Patients being treated with Tarceva have been advised to consult a doctor immediately if they experience any of the following signs or symptoms suggesting possible serious liver side effects:

•    dark urine
•    yellowing of the skin
•    abdominal pain, especially on the right side
•    general itchiness
•    decreased appetite
•    nausea or vomiting
•    fatigue or tiredness

Patients who have had any liver problems before beginning treatment with Tarceva, or who experience liver problems during treatment, including "abnormal tests for liver function", should tell their doctor or pharmacist, Health Canada said.

In September, the U.S. Food & Drug Administration (FDA) also announced changes to the Tarceva label to reflect risks to patients with liver impairment.  In the PRECAUTIONS section of the label, sections entitled “Patients with Hepatic Impairment”, “Hepatotoxicity” and “Renal Failure” were updated with relevant information and moved to the WARNINGS section.  The DOSAGE AND ADMINISTRATION section has also been updated.

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