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. ... Read moreBevacizumab 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: (1) Platinum-resistant in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan. (2) Platinum-sensitive in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine, followed by Bevacizumab as a single agent. Limitation of Use: Bevacizumab is not indicated for adjuvant treatment of colon cancer.

Targeted Cancer Therapy

Bevacizumab binds VEGF and prevents the interaction of VEGF to its receptors (Flt-1 and KDR) on the surface of endothelial cells. The interaction of VEGF with its receptors leads to endothelial cell proliferation and new blood vessel formation in in vitro models of angiogenesis. Administration of bevacizumab to xenotransplant models of colon cancer in nude (athymic) mice caused reduction of microvascular growth and inhibition of metastatic disease progression.

A drug interaction study was performed in which irinotecan was administered as part of the FOLFIRIregimen with or without Bevacizumab. The results demonstrated no significant effect of bevacizumab on the pharmacokinetics of irinotecan or its active metabolite SN38.

There are no contraindications listed in the manufacturer’s labeling.

Most common adverse reactions (incidence >10% and at least twice the control arm rate) are epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, rectal hemorrhage, lacrimation disorder, back pain and exfoliative dermatitis.

Pregnancy Category C. There are no adequate or well controlled studies of bevacizumab in pregnant women.  It is not known whether Avastin is secreted in human milk.

Perforation or Fistula: Discontinue Bevacizumab if perforation or fistula occurs.Arterial Thromboembolic Events or ATE (e.g., myocardial infarction, cerebral infarction): Discontinue Bevacizumab for severe ATE.Venous Thromboembolic Events or VTE: Discontinue Bevacizumab for lifethreatening VTE.Hypertension: Monitor blood pressure and treat hypertension. Temporarily suspend Bevacizumab if not medically controlled. Discontinue Bevacizumab for hypertensive crisis or hypertensive encephalopathy.Posterior Reversible Encephalopathy Syndrome (PRES): Discontinue Bevacizumab.Proteinuria: Monitor urine protein. Discontinue Bevacizumab for nephrotic syndrome. Temporarily suspend Bevacizumab for moderate proteinuria.Infusion Reactions: Stop Bevacizumab for severe infusion reactions.Embryo-fetal Toxicity: Advise females of potential risk to a fetus and the need for use of effective contraception.Ovarian Failure: Advise females of the potential risk.

The highest dose tested in humans (20 mg/kg IV) was associated with headache in nine out of 16 patients and with severe headache in three out of 16 patients.

Store the Bevacizumab vial in a refrigerator at 2-8°C. Keep the vial in the outer carton due to light sensitivity. Do not freeze. Keep out of reach of children.

Targeted Cancer Therapy

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.

Pregnancy: Bevacizumab may cause fetal harm based on findings from animal studies and the drug’s mechanism of action.Lactation: No data are available regarding the presence of bevacizumab in human milk, the effects on the breast fed infant, or the effects on milk production. Human IgG is present in human milk, but published data suggest that breast milk antibodies do not enter the neonatal and infant circulation in substantial amounts. Because of the potential for serious adverse reactions in breastfed infants from bevacizumab, advise a nursing woman that breastfeeding is not recommended during treatment with Bevacizumab.