《贝伐珠单抗注射液说明书fda-genentech资料》由会员分享，可在线阅读，更多相关《贝伐珠单抗注射液说明书fda-genentech资料（35页珍藏版）》请在金锄头文库上搜索。
1、 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use AVASTIN safely and effectively. See full prescribing information for AVASTIN. AVASTIN (bevacizumab) Solution for intravenous infusion Initial U.S. Approval: 2004 WARNING: GASTROINTESTINAL PERFORA
2、TIONS, SURGERY AND WOUND HEALING COMPLICATIONS, and HEMORRHAGE See full prescribing information for complete boxed warning. Gastrointestinal Perforation: Occurs in up to 3.2% of Avastin-treated patients. Discontinue Avastin for gastrointestinal perforation. (5.1) Surgery and Wound Healing Complicati
3、ons: Discontinue in patients with wound dehiscence. Discontinue at least 28 days prior to elective surgery. Do not initiate Avastin for at least 28 days after surgery and until the surgical wound is fully healed. (5.3) Hemorrhage: Severe or fatal hemorrhage, hemoptysis, gastrointestinal bleeding, CN
4、S hemorrhage, and vaginal bleeding are increased in Avastin- treated patients. Do not administer Avastin to patients with serious hemorrhage or recent hemoptysis. (5.4) -RECENT MAJOR CHANGES- Indications and Usage (1.5) 08/2014 Indications and Usage (1.6) 11/2014 Dosage and Administration (2.2) 11/2
5、014 Warnings and Precautions, Gastrointestinal Perforations and Fistulae (5.1) 11/2014 Warnings and Precautions, Non-Gastrointestinal Fistulae 11/2014 (5.2) Warnings and Precautions, Hemorrhage (5.4) 08/2014 Warnings and Precautions, Venous Thromboembolic Events 08/2014 (5.6) Warnings and Precaution
6、s, Posterior Reversible 08/2014 Encephalopathy Syndrome (PRES) (5.8) Warnings and Precautions, Embryo-fetal Toxicity (5.11) 05/2015 -INDICATIONS AND USAGE- Avastin is a vascular endothelial growth factor-specific angiogenesis inhibitor indicated for the treatment of: Metastatic colorectal cancer, wi
7、th intravenous 5-fluorouracilbased chemotherapy for first- or second-line treatment. (1.1) Metastatic colorectal cancer, with fluoropyrimidine- irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line Avastin containing
8、regimen. (1.1) Non-squamous non-small cell lung cancer, with carboplatin and paclitaxel for first line treatment of unresectable, locally advanced, recurrent or metastatic disease. (1.2) Glioblastoma, as a single agent for adult patients with progressive disease following prior therapy. (1.3) -Effec
9、tiveness based on improvement in objective response rate. No data available demonstrating improvement in disease-related symptoms or survival with Avastin. Metastatic renal cell carcinoma with interferon alfa (1.4) Cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topot
10、ecan in persistent, recurrent, or metastatic disease. (1.5) Platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan (1.6) Limitation of Use: Avastin is not indicated for adjuvant treatm
11、ent of colon cancer. (1.1) -DOSAGE AND ADMINISTRATION- Do not administer as an IV push or bolus. (2.1) Do not initiate Avastin for 28 days following major surgery and until surgical wound is fully healed. (2.1) Metastatic colorectal cancer (2.2) 5 mg/kg IV every 2 weeks with bolus-IFL 10 mg/kg IV ev
12、ery 2 weeks with FOLFOX4 5 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 Avastin containing regimen Nonsquamous nonsmall cell lung cancer (2.2) 15 mg/kg IV every 3 weeks with
13、carboplatin/paclitaxel Glioblastoma (2.2) 10 mg/kg IV every 2 weeks Metastatic renal cell carcinoma (mRCC) (2.2) 10 mg/kg IV every 2 weeks with interferon alfa Persistent, recurrent, or metastatic carcinoma of the cervix (2.2) 15 mg/kg IV every 3 weeks with paclitaxel/cisplatin or paclitaxel/topotec
14、an Platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer (2.2) 10 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 -DOSAGE FORMS AND STRENGTHS- 100 mg/4 mL,
15、single use vial (3) 400 mg/16 mL, single use vial (3) -CONTRAINDICATIONS- None (4) -WARNINGS AND PRECAUTIONS- Perforation or Fistula: Discontinue Avastin if perforation or fistula occurs. (5.1, 5.2) Arterial Thromboembolic Events (e.g., myocardial infarction, cerebral infarction): Discontinue Avastin for severe ATE. (5.5) Venous Thromboembolic Events: Discontinue Avastin for life- threatening VTE (5.6) Hypertension: Monitor blood pressure an
