What Is Avastex 400 mg/16 ml Indications and Uses?

Avastex 400 mg/16 ml (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 Avastex containing regimen. ... Read more Avastex 400 mg/16 ml (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 Avastex 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 Avastex is based on improvement in objective response rate. No data available demonstrating improvement in disease-related symptoms or survival with Avastex. 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 Avastex as a single agent. Limitation of Use: Avastex is not indicated for adjuvant treatment of colon cancer.

Pharmacology (Source, Chemical and Physical Composition) Of Avastex 400 mg/16 ml

Avastex 400 mg/16 ml (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.

Drug Interactions of Avastex 400 mg/16 ml

A drug interaction study was performed in which irinotecan was administered as part of the FOLFIRI regimen with or without Avastex 400 mg/16 ml (Bevacizumab). The results demonstrated no significant effect of Avastex on the pharmacokinetics of irinotecan or its active metabolite SN38.

Side Effects of Avastex 400 mg/16 ml

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.

Precautions And Warnings for Avastex 400 mg/16 ml

Perforation or Fistula : Discontinue Avastex 400 mg/16 ml (Bevacizumab) if perforation or fistula occurs. Arterial Thromboembolic Events or ATE (e.g., myocardial infarction, cerebral infarction): Discontinue Avastex for severe ATE. Venous Thromboembolic Events or VTE : Discontinue Avastex for lifethreatening VTE. Hypertension : Monitor blood pressure and treat hypertension. Temporarily suspend Avastex if not medically controlled. Discontinue Avastex for hypertensive crisis or hypertensive encephalopathy. Posterior Reversible Encephalopathy Syndrome (PRES) : Discontinue Avastex. Proteinuria : Monitor urine protein. Discontinue Avastex for nephrotic syndrome. Temporarily suspend Avastex for moderate proteinuria. Infusion Reactions : Stop Avastex 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.

Use During Pregnancy and Lactation

Pregnancy : Avastex 400 mg/16 ml (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.

Therapeutic Class

Targeted Cancer Therapy

Storage Conditions of It

Store the Avastex 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. Pack Image: Avastex 400 mg/16 ml IV Infusion Thanks for using MedEx! How would you rate your experience so far?