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Avastin IV Infusion contains Bevacizumab

Avastin IV Infusion uses for

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 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

• Platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan

Limitation of Use: Bevacizumab is not indicated for adjuvant treatment of colon cancer.

Bevacizumab should not be administered as an IV push or bolusBevacizumab should not be initiated for 28 days following major surgery and until surgical wound is fully healed

• Metastatic colorectal cancer5 mg/kg IV every 2 weeks with bolus-IFL10 mg/kg IV every 2 weeks with FOLFOX45 mg/kg IV every 2 weeks or 7.5 mg/kg IV every 3 weeks with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin based chemotherapy after progression on a first-line Bevacizumab containing regimen

• Non-squamous non-small cell lung cancer15 mg/kg IV every 3 weeks with carboplatin/paclitaxel• Glioblastoma10 mg/kg IV every 2 weeks

• Metastatic renal cell carcinoma (mRCC)10 mg/kg IV every 2 weeks with interferon alfa

• Persistent, recurrent, or metastatic carcinoma of the cervix15 mg/kg IV every 3 weeks with paclitaxel/cisplatin or paclitaxel/topotecan

• Platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer10 mg/kg IV every 2 weeks with paclitaxel, pegylated liposomal doxorubicin or weekly topotecan 15 mg/kg IV every 3 weeks with topotecan given every 3 weeks

Do not administer as an intravenous push or bolus. Administer only as an intravenous (IV) infusion. Do not initiate Bevacizumab until at least 28 days following major surgery. Administer Bevacizumab after the surgical incision has fully healed.

First infusion: Administer infusion over 90 minutes. Subsequent infusions: Administer second infusion over 60 minutes if first infusion is tolerated; administer all subsequent infusions over 30 minutes if infusion over 60 minutes is tolerated.

Use appropriate aseptic technique. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Withdraw necessary amount of Bevacizumab and dilute in a total volume of 100 ml of 0.9% Sodium Chloride Injection, USP. Discard any unused portion left in a vial, as the product contains no preservatives.

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

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