Bevacizumab 25mg/ml; 4ml (100mg) vial: Injection.

Ind: Bevacizumab in combination with fluoropyrimidine-based chemotherapy is indicated for the first-line treatment of patients with metastatic carcinoma of the colon or rectum. C/I: Bevacizumab is contraindicated in patients with known hypersensitivity to any components of the product (Chinese hamster ovary cell products or other recombinant human or humanised antibodies).

S/E: Common adverse events of any grade that were identified as possibly bevacizumab related toxicities were anorexia, constipation, epistaxis, hypertension, proteinuria and pain. Patients treated with bevacizumab with or without chemotherapy in any trials included decreased neutrophil count, decreased white blood count, protein urine present, decreased blood potassium, decreased blood phosphorus, increased blood glucose & increased blood alkaline phosphatase. Precautions: Hypertension: Caution should be exercised before initiated bevacizumab therapy in these patients. Monitoring of blood pressure is recommended during bevacizumab therapy. Wound healing: It is recommended that bevacizumab therapy not be initiated within 28 days following major surgery as such patients were excluded from clinical trials.

Pregnancy & lactation: Bevacizumab should not be used during pregnancy. In women with childbearing potential, appropriate contraceptive measures are recommended during bevacizumab

therapy. Women should be advised to discontinue nursing during bevacizumab therapy and not to breast feed for at least 6 months following the last dose of the therapy.

Dosage & admin: The recommended dose of bevacizumab is 5mg/kg of body weight given once every 14 days as an intravenous infusion. Bevacizumab should be prepared by a healthcare professional using aseptic technique. Withdraw the volume of bevacizumab equivalent to a dose of 5mg/kg body weight and dilute in a total volume of 100ml of sterile, pyrogen-free 0.9% sodium chloride. No incompatibilities between bevacizumab and polyvinyl chloride or polyolefin bags have been observed (error! reference source not found). Bevacizumab infusions should not be administered or mixed with dextrose or glucose solutions (error! reference source not found). Do not administer as an intravenous push or bolus. The initial bevacizumab dose should be delivered over 90 minutes as an intravenous infusion. If the first infusion is well tolerated, the second infusion may be administered over 60 minutes. If the 60-minute infusion is well tolerated, all subsequent infusions may be administered over 30 minutes.

After resolution of the vial content chemical and physical in-use stability has been demonstrated for 48 hours at 2°C-30°C in 0.9% sodium chloride solution. However, from a microbiological point of view, the product should be used immediately.

Drugs inter: No formal drug interaction studies with other antineoplastic agents have been conducted. However, the existing data suggest that bevacizumab does not affect the pharmacokinetics of 5-fluorouracil (5-FU), carboplatin, paclitaxel and doxorubicin.

Storage: Store vials in a refrigerator at 2°C-8°C. Keep vial in the outer carton of the refrigerator due to light sensitivity. Do not freeze. Do not shake.

Price: 100mg (4ml) vial x l's pack: 45,000.00 TP