Avastin Bevacizumab Injection

Brand Name: 安维汀 ®(Avastin®)
Generic Name: Bevacizumab
Strength: 100 mg per 4 mL vial, 1 vial per box
Manufacturer: Roche Diagnostics GmbH
Marketing Authorization Holder: F. Hoffmann-La Roche Ltd.
Approval Date in China: February 26, 2010
Registration Number: 国药准字SJ20170035
Storage: Store protected from light at 2°C–8°C in original packaging; do not freeze or shake. Keep out of reach of children. Refer to the full package insert for detailed storage specifications.

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1. Indications and Usage
Metastatic Colorectal Cancer: Indicated in combination with fluoropyrimidine-based chemotherapy for the treatment of metastatic colorectal cancer.
Non-Small Cell Lung Cancer: Indicated for the treatment of unresectable locally advanced, recurrent, or metastatic non-squamous non-small cell lung cancer in combination with platinum-based chemotherapy.
Glioblastoma: Indicated for the treatment of glioblastoma, the most aggressive type of brain tumor in adults.
Ovarian Cancer: Indicated in combination with chemotherapy for the adjuvant treatment of patients with ovarian cancer.
Cervical Cancer: Indicated in combination with chemotherapy for the treatment of persistent, recurrent, or metastatic cervical cancer.
2. Dosage and Administration
Dosing Regimen: The dose varies by cancer type, typically ranging from 5 mg/kg to 15 mg/kg, administered intravenously every 2 or 3 weeks.
Infusion Time: The initial infusion should be administered over 90 minutes. If the first infusion is well tolerated, the second may be administered over 60 minutes. Subsequent infusions may be administered over 30 minutes.
Preparation: Bevacizumab must be diluted with 0.9% Sodium Chloride Injection. It should not be administered as an intravenous bolus or push.
Surgical Timing: Discontinue bevacizumab at least 6 weeks prior to elective surgery and do not resume for at least 4 weeks after surgery.
3. Mechanism of Action
Bevacizumab is a recombinant humanized monoclonal antibody that binds with high affinity to human vascular endothelial growth factor (VEGF-A), preventing its interaction with VEGF receptors (Flt-1 and KDR) on the surface of endothelial cells. This inhibition blocks the signaling pathways responsible for tumor angiogenesis, microvascular permeability, and tumor cell survival, ultimately inhibiting tumor growth and metastasis.
4. Safety and Warnings
Gastrointestinal Perforation and Fistulas: Gastrointestinal perforation and fistula formation (e.g., gastrocolic, tracheoesophageal) can occur and may be fatal. Permanent discontinuation is required if these events occur.
Hemorrhage: Serious and fatal hemorrhage, including pulmonary hemorrhage (hemoptysis) and gastrointestinal bleeding, can occur. The drug is contraindicated in patients with significant bleeding risk.
Wound Complications: Bevacizumab may impair wound healing. It should be withheld prior to surgery and not resumed until the wound has fully healed.
Hypertension: Severe hypertension and hypertensive crisis may occur. Blood pressure should be monitored regularly, and severe hypertension must be controlled before continuing therapy.
Thromboembolic Events: Arterial and venous thromboembolic events have been reported.
5. Adverse Reactions and Clinical Research
The most common adverse reactions include hypertension, proteinuria, fatigue, abdominal pain, and diarrhea. Clinical research has demonstrated that the addition of bevacizumab to standard chemotherapy regimens significantly improves progression-free survival and overall response rates across multiple solid tumor types.
6. Drug Interactions
Chemotherapy Agents: Bevacizumab is typically used in combination with various chemotherapeutic agents. Careful management of overlapping toxicities is required.
Vaccines: Live vaccines should be avoided during treatment.
Surgical Agents: As noted, appropriate timing is necessary regarding perioperative care to prevent wound healing complications.
7. Pharmaceutical Information
Composition: The active ingredient is bevacizumab, a recombinant humanized monoclonal IgG1 antibody produced in Chinese Hamster Ovary (CHO) cells.
Appearance: It is a clear to slightly opalescent, colorless to slightly yellow liquid.
Storage: Store at 2°C to 8°C. Do not freeze or shake. Protect from light.

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