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Wyeth's TORISEL Receives European Commission Approval for the Treatment of Advanced Kidney Cancer
Date:11/26/2007

RCC with poor-risk features. In August 2007, the National Comprehensive Cancer Network (NCCN) in the United States added TORISEL to the NCCN Kidney Cancer Guidelines as an option in first-line therapy for both predominant clear cell histology and non-clear cell histology and as a subsequent therapy option for patients with predominant clear cell histology.

TORISEL U.S. Important Safety Information

Hypersensitivity reactions manifested by symptoms, including, but not limited to anaphylaxis, dyspnea, flushing, and chest pain have been observed with TORISEL.

Serum glucose, serum cholesterol, and triglycerides should be tested before and during treatment with TORISEL.

The use of TORISEL is likely to result in hyperglycemia and hyperlipemia. This may result in the need for an increase in the dose of, or initiation of, insulin and/or oral hypoglycemic agent therapy and/or lipid-lowering agents, respectively.

The use of TORISEL may result in immunosuppression. Patients should be carefully observed for the occurrence of infections, including opportunistic infections.

Cases of interstitial lung disease, some resulting in death, have occurred. Some patients were asymptomatic and others presented with symptoms. Some patients required discontinuation of TORISEL and/or treatment with corticosteroids and/or antibiotics.

Cases of fatal bowel perforation occurred with TORISEL. These patients presented with fever, abdominal pain, metabolic acidosis, bloody stools, diarrhea, and/or acute abdomen.

Cases of rapidly progressive and sometimes fatal acute renal failure not clearly related to disease progression occurred in patients who received TORISEL.

Due to abnormal wound healing, use TORISEL with caution in the perioperative period.

Patients with central nervous system tumors (primary CNS tumor or metastases) and/or receiving anticoagulation therapy may be at an increased risk of developing intracerebral bleeding (i
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SOURCE Wyeth Pharmaceuticals
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