Formulation and specifications: Injection: 100mg (4ml)/bottle
Indications:
1. Bevacizumab in combination with fluorouracil-based chemotherapy is indicated for the treatment of patients with metastatic colorectal cancer.
2. Bevacizumab in combination with atelelizumab for the treatment of patients with unresectable hepatocellular carcinoma who have not previously received systemic systemic therapy.
Key points for rational drug use:
1. First- and second-line treatment of patients with metastatic colorectal cancer with bevacizumab + chemotherapy.
2. First-line treatment with a bevacizumab-containing regimen for disease control followed by maintenance with bevacizumab + fluorouracil analogs until disease progression.
3. Patients with progressive disease treated with bevacizumab in first line may continue to be treated with bevacizumab in combination with chemotherapy until disease progression again after switching to second line chemotherapy regimens.
4. The recommended dose of intravenous infusion of bevacizumab for metastatic colorectal cancer is 5 mg/kg body weight given every two weeks or 7.5 mg/kg body weight given every three weeks in combination with chemotherapy regimens. A lower dose of bevacizumab is not recommended.
5. The combination of this product with atelelizumab for the treatment of hepatocellular carcinoma is based on the IMBrave150 study: the recommended dose is 15 mg/kg intravenously, administered on the same day after 1200 mg of intravenous atelelizumab, every 3 weeks until disease progression or intolerable toxicity occurs.
6. Bevacizumab is administered by intravenous infusion after dilution, and the first intravenous infusion is required to last 90 minutes. If the first infusion is well tolerated, the duration of the second infusion may be reduced to 60 minutes. If the patient also tolerates the 60-minute infusion well, all subsequent infusions can be completed in 30-minute increments. Bevacizumab should not be administered by intravenous push or rapid injection.
7. No dose adjustment is required for application in elderly patients.
8. Discontinue bevacizumab in the presence of: serious gastrointestinal adverse reactions (gastrointestinal perforation, gastrointestinal fistula formation, abdominal abscess) involving visceral fistula formation; severe bleeding (e.g., requiring interventional therapy); serious arterial thrombotic events; hypertensive crisis or hypertensive encephalopathy; reversible posterior leukoencephalopathy syndrome; nephrotic syndrome; life-threatening (grade 4) venous thromboembolic events.
9. Bevacizumab should be withheld if the following conditions occur: 4 weeks prior to elective surgery; severe hypertension that is poorly controlled by medication; moderate to severe proteinuria requiring further evaluation; severe infusion reactions; wound dehiscence requiring intervention and wound healing complications (withhold medication until complete wound healing).
10. Bevacizumab infusion should not be administered concurrently with or mixed with dextrose or glucose solution.
11. Bevacizumab is formulated and diluted with 0.9% sodium chloride solution to the desired volume of administration. The final concentration of bevacizumab solution should be maintained between 1.4 and 16.5 mg/ml.
12. Bevacizumab is prohibited to be stored frozen and shaking is prohibited. It should be stored and transported away from light, at 2~8℃ in the original package.
13. The chemical and physical stability of bevacizumab can be maintained for 48 hours during use in 0.9% sodium chloride solution at 2～30℃. The storage time of the product should not exceed 24 hours under 2~8℃ after preparation under sterile conditions.