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Bevacizumab Label Changes

TOP - October 2011 Vol 4, No 7 published on October 20, 2011 in FDA Updates

The FDA issued a statement warning physicians of changes in the package insert for bevacizumab (Avastin, Genentech) regarding newly identified risks.

  • Increased risk for ovarian failure. New cases of ovarian failure were identified in 34% of women receiving bevacizumab in combination with chemotherapy compared with 2% of women receiving chemotherapy alone. After discontinuation of bevacizumab, recovery of ovarian function was demonstrated in 22% of these women.
  • Osteonecrosis of the jaw. Postmarketing, osteonecrosis of the jaw was reported in patients receiving bevacizu - mab but not bisphosphonates. The pathogenesis is unclear, but it is possible that the antiangiogenic properties of bevacizumab may result in bone tissue avascularization leading to ischemic changes in the microvasculature of the jaw, resulting in osteonecrosis.
  • Venous thromboembolic event (VTE) and bleeding in patients receiving anticoagulation therapy after first VTE event. In patients with metastatic colorectal cancer, prospective evaluation found the overall incidence of first VTE was higher with bevacizumab (13.5%) than with chemotherapy alone (9.6%). Among patients treated with anticoagulants following an initial VTE event, the overall incidence of subsequent VTEs was also higher among those treated with bevacizumab (31.5% vs 25.6%, respectively) and the overall incidence of bleeding was higher in the bevacizumab group (27.4% vs 20.9%, respectively)
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Last modified: September 9, 2019