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Amgen Highlights Data to be Presented at 2011 European Multidisciplinary Cancer Congress
Date:9/23/2011

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Important U.S. Product Safety InformationWARNING: DERMATOLOGIC TOXICITY and INFUSION REACTIONSDermatologic Toxicity: Dermatologic toxicities occurred in 89 percent of patients and were severe (NCI-CTC grade 3 or higher) in 12 percent of patients receiving Vectibix monotherapy. [See Dosage and Administration (2.1), Warnings and Precautions (5.1), and Adverse Reactions (6.1)].Infusion Reactions: Severe infusion reactions occurred in approximately one percent of patients. Fatal infusion reactions occurred in postmarketing experience [See Dosage and Administration (2.1), Warnings and Precautions (5.2), and Adverse Reactions (6.1, 6.3)].The most common adverse events of Vectibix are skin rash with variable presentations, hypomagnesemia, paronychia, fatigue, abdominal pain, nausea, and diarrhea, including diarrhea resulting in dehydration.Important European Product Safety InformationFor full prescribing information please see the Summary of Product Characteristics.

Vectibix is indicated as monotherapy for the treatment of patients with EGFR expressing, mCRC with non-mutated (wild-type) KRAS after failure of fluoropyrimidine-, oxaliplatin- and irinotecan-containing chemotherapy regimens.

Vectibix is contraindicated in patients with a history of severe or life-threatening hypersensitivity reactions to the product and in patients with interstitial pneumonitis or pulmonary fibrosis.

Other adverse events of special importance associated with Vectibix and/or EGFR monoclonal antibody therapies include dermatologic related reactions, pulmonary complications, electrolyte disturbances and infusion related reactions (including rare reports with fatal outcome). Acute renal failure has been observed in patients who develop severe diarrhea and dehydration. Serious cases of keratitis and ulcerative keratitis have been rarely reported in the post-marketing setting. These events should be monitored carefully, see Summary of Product Character
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