Bevacizumab is a Vascular Endothelial Growth Factor (VEGF) directed recombinant humanized monoclonal antibody that blocks the VEGF to bind with its receptor VEGFR on the surface of endothelial cells. The prevention of binding VEGF with VEGFR leads to the inhibition of new blood vessel formation known as angiogenesis that feeds the cancer cells. Thus, Bevacizumab stops the growth & metastasis of cancer.
Bevacizumab is a Vascular Endothelial Growth Factor (VEGF) directed at a recombinant humanized monoclonal antibody (mAb) that blocks the VEGF to bind with its receptor VEGFR on the surface of endothelial cells. The prevention of binding VEGF with VEGFR leads to the inhibition of new blood vessel formation known as angiogenesis that feeds the cancer cells. Thus, Bevacizumab stops the growth & metastasis of different types of cancer. Bevacizumab significantly increases OS & PFS in cancer patients when given with chemotherapy.
Bevaris 100 Concentrated Solution for IV Infusion: Each vial contains Bevacizumab INN 100 mg as 4 ml concentrated solution for IV infusion.
Bevaris 400 Concentrated Solution for IV Infusion: Each vial contains Bevacizumab INN 400 mg as 16 ml concentrated solution for IV infusion.
• Metastatic colorectal cancer, in combination with intravenous 5-fluorouracil-based chemotherapy for first- or second-line treatment.
• Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin based chemotherapy for second-line treatment in patients who have progressed on a first-line Bevacizumab-containing regimen.
• Unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment.
• Recurrent glioblastoma in adults.
• Metastatic renal cell carcinoma in combination with interferon alfa.
• Persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel and cisplatin, or paclitaxel and topotecan.
• Epithelial ovarian, fallopian tube, or primary peritoneal cancer:
• in combination with carboplatin and paclitaxel, followed by Bevacizumab as a single agent, for stage III or IV disease following initial surgical resection.
• in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease who received no more than 2 prior chemotherapy regimens.
• in combination with carboplatin and paclitaxel or carboplatin and gemcitabine, followed by Bevacizumab as a single agent, for platinum sensitive recurrent disease.
• Hepatocellular Carcinoma:
• in combination with atezolizumab for the treatment of patients with unresectable or metastatic HCC who have not received prior systemic therapy.
• Age-related Macular Degeneration (AMD)
Bevacizumanb is not recommended to be used within 28 days of a major surgery and until surgical wound is fully healed.
Metastatic colorectal cancer
• 5 mg/kg every 2 weeks with bolus-IFL
• 10 mg/kg every 2 weeks with FOLFOX4
• 5 mg/ kg every 2 weeks or 7.5 mg/kg every 3 weeks with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin-based
chemotherapy after progression on a first-line Bevacizumab containing regimen
First-Line Non−squamous non−small cell lung cancer
• 15 mg/kg every 3 weeks with carboplatin and paclitaxel
Recurrent glioblastoma
• 10 mg/kg every 2 weeks
Metastatic renal cell cancer
• 10 mg/kg every 2 weeks with interferon alfa
Persistent, recurrent, or metastatic cervical cancer
• 15 mg/kg every 3 weeks with paclitaxel and cisplatin, or paclitaxel and topotecan
Stage III or IV epithelial ovarian, fallopian tube or primary peritoneal cancer following initial surgical resection
• 15 mg/kg every 3 weeks with carboplatin and paclitaxel for up to 6 cycles, followed by 15 mg/kg every 3 weeks as a single
agent, for a total of up to 22 cycles
Platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer
• 10 mg/kg every 2 weeks with paclitaxel, pegylated liposomal doxorubicin, or topotecan given every week
• 15 mg/kg every 3 weeks with topotecan given every 3 weeks
Platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer
• 15 mg/kg every 3 weeks with carboplatin and paclitaxel for 6-8 cycles, followed by 15 mg/kg every 3 weeks as a single agent
• 15 mg/kg every 3 weeks with carboplatin and gemcitabine for 6-10 cycles, followed by 15 mg/kg every 3 weeks as a single
agent
Hepatocellular Carcinoma
• 15 mg/kg after administration of 1,200 mg of atezolizumab every 3 weeks.
Age-related Macular Degeneration (AMD)
• 1.25 mg/0.05 ml intravitreal injection every 4 or 8 weeks.
Bevacizumab is administered as an intravenous infusion. The first infusion is administered over 90 minutes; the second infusion is
administered over 60 minutes if first infusion is tolerated. All subsequent infusions are administered over 30 minutes if second
infusion over 60 minutes is tolerated.
None.
Pregnancy: Bevacizumab may cause fetal harm when administered to a pregnant woman. Female of reproductive potential should
be advised to use effective contraception during treatment with Bevacizumab and for 6 months after the last dose of Bevacizumab.
Nursing mothers: Because of the potential for serious adverse reactions in breastfed infants from bevacizumab, women should be
advised not to breastfeed during treatment with Bevacizumab and for 6 months following the final dose.
Pediatric use: The safety and effectiveness of Bevacizumab in pediatric patients have not been established. Bevacizumab is not
approved for use in patients under the age of 18 years.
Geriatric use: The overall incidence of arterial thromboembolic events increases in patients receiving Bevacizumab with
chemotherapy, this incidence is greater in patients ≥ 65 years.
Precaution in other cases:
• Discontinue for tracheoesophageal fistula, grade 4 fistula, or necrotizing fasciitis. Discontinue for severe Arterial Thromboembolic Events.
• Discontinue for Grade 4 Venous Thromboembolic Events.
• Monitor blood pressure and treat hypertension. Withhold if not medically controlled; resume once controlled. Discontinue for hypertensive crisis or hypertensive encephalopathy.
• Discontinue in case of Posterior Reversible Encephalopathy Syndrome.
• Monitor urine protein. Discontinue for nephrotic syndrome. Withhold until less than 2 grams of protein in urine.
• Decrease the infusion rate in case of infusion reactions. Discontinue for severe infusion reactions and administer medical therapy.
• Discontinue Bevacizumab in patients who develop Congestive Heart Failure.
Most common adverse reactions incidence (incidence > 10%) are epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, hemorrhage, lacrimation disorder, back pain and exfoliative dermatitis.
Based on the results of population pharmacokinetic analyses, no clinically relevant interaction of co-administered chemotherapy on Bevacizumab pharmacokinetics was observed, no clinically relevant interaction of bevacizumab was observed on the pharmacokinetics of co-administered chemotherapy either.
Pregnancy: Bevacizumab may cause fetal harm when administered to a pregnant woman. Female of reproductive potential should
be advised to use effective contraception during treatment with Bevacizumab and for 6 months after the last dose of Bevacizumab.
Nursing mothers: Because of the potential for serious adverse reactions in breastfed infants from bevacizumab, women should be
advised not to breastfeed during treatment with Bevacizumab and for 6 months following the final dose.
Pediatric use: The safety and effectiveness of Bevacizumab in pediatric patients have not been established. Bevacizumab is not
approved for use in patients under the age of 18 years.
Geriatric use: The overall incidence of arterial thromboembolic events increases in patients receiving Bevacizumab with
chemotherapy, this incidence is greater in patients ≥ 65 years.
Bevaris 100 Concentrated Solution for IV Infusion: Each box contains a single-dose glass vial of Bevacizumab 100 mg.
Bevaris 400 Concentrated Solution for IV Infusion: Each box contains a single-dose glass vial of Bevacizumab 400 mg.
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