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Bevacizumab is a recombinant humanized monoclonal IgG1 antibody that binds to and inhibits the biologic activity of human vascular endothelial growth factor (VEGF) in-vitro and in-vivo assay systems. Bevacizumab contains human framework regions and the complementarity-determining regions of a murine antibody that binds to VEGF. Bevacizumab has an approximate molecular weight of 149 kD. Bevacizumab is produced in a mammalian cell (Chinese Hamster Ovary) expression system in a nutrient medium containing the antibiotic gentamicin. Gentamicin is not detectable in the final product. Bevacizumab is a clear to slightly opalescent, colorless to pale brown, sterile, pH 6.2 solution for intravenous infusion.
Bevacizumab is a vascular endothelial growth factor-specific angiogenesis inhibitor indicated for the treatment of:
• Metastatic colorectal cancer, with intravenous 5-fluorouracil–based chemotherapy for first-or second-line treatment.
• Metastatic colorectal cancer, with fluoropyrimidine- irinotecan or fluoropyrimidine-oxaliplatin based chemotherapy for second-line treatment in patients who have progressed on a first-line Bevacizumab containing regimen.
• Non-squamous non-small cell lung cancer, with carboplatin and paclitaxel for first line treatment of unresectable, locally advanced, recurrent or metastatic disease.
• Glioblastoma, as a single agent for adult patients with progressive disease following prior therapy. Effectiveness of Bevacizumab is based on improvement in objective response rate. No data available demonstrating improvement in disease-related symptoms or survival with Bevacizumab.
• Metastatic renal cell carcinoma with interferon alfa.
• Cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan in persistent, recurrent, or metastatic disease.
• Recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer that is-
• Platinum-resistant in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan,
• Platinum-sensitive in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine, followed by Bevacizumab as a single agent.
Bevacimab100: Bevacimab 100 mg is supplied as a sterile, preservative free solution in 6 ml glass vial containing 100 mg of Bevacizumab INN.
Bevacimab 400: Bevacimab 400 mg is supplied as a sterile, preservative free solution in 20 ml glass vial containing 100 mg of Bevacizumab INN.