No formal drug interaction studies with anti‑neoplastic agents have been conducted. In Study 1, patients with colorectal cancer were given irinotecan/5‑FU/leucovorin (bolus‑IFL) with or without AVASTIN. Irinotecan concentrations were similar in patients receiving bolus‑IFL alone and in combination with AVASTIN. The concentrations of SN38, the active metabolite of irinotecan, were on average 33% higher in patients receiving bolus‑IFL in combination with AVASTIN when compared with bolus‑IFL alone. In Study 1, patients receiving bolus‑IFL plus AVASTIN had a higher incidence of NCI‑CTC Grade 3–4 diarrhea and neutropenia. Due to high inter‑patient variability and limited sampling, the extent of the increase in SN38 levels in patients receiving concurrent irinotecan and AVASTIN is uncertain.
In Study 6, based on limited data, there did not appear to be a difference in the mean exposure of either carboplatin or paclitaxel when each was administered alone or in combination with AVASTIN. However, 3 of the 8 patients receiving AVASTIN plus paclitaxel/carboplatin had substantially lower paclitaxel exposure after four cycles of treatment (at Day 63) than those at Day 0, while patients receiving paclitaxel/carboplatin without AVASTIN had a greater paclitaxel exposure at Day 63 than at Day 0.
- Presta LG, Chen H, O'Connor SJ, Chisholm V, Meng YG, Krummen L, et al. Humanization of an anti‑vascular endothelial growth factor monoclonal antibody for the therapy of solid tumors and other disorders. Cancer Res 1997;57:4593–9.
For Intravenous Use
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Initial U.S. Approval: February 2004
Code Revision Date: September 2007
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