Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
BEVACIZUMAB (UNII: 2S9ZZM9Q9V) (BEVACIZUMAB - UNII:2S9ZZM9Q9V)
CELLTRION USA, Inc.
INTRAVENOUS
PRESCRIPTION DRUG
VEGZELMA, in combination with intravenous fluorouracil-based chemotherapy, is indicated for the first- or second-line treatment of patients with metastatic colorectal cancer (mCRC). VEGZELMA, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, is indicated for the second-line treatment of patients with mCRC who have progressed on a first-line bevacizumab product-containing regimen. Limitations of Use : VEGZELMA is not indicated for adjuvant treatment of colon cancer [see Clinical Studies (14.2)]. VEGZELMA, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non–squamous non–small cell lung cancer (NSCLC). VEGZELMA is indicated for the treatment of recurrent glioblastoma (GBM) in adults. VEGZELMA, in combination with interferon alfa, is indicated for the treatment of metastatic renal cell carcinoma (mRCC). VEGZELMA, in combination with paclitaxel and ci
VEGZELMA (bevacizumab-adcd) injection is a clear to opalescent, colorless to pale brown, sterile solution for intravenous infusion supplied in a single-dose vial pakcaged within cartons in the following strengths and packaging configurations: Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton until time of use to protect from light. Do not freeze or shake the vial or carton.
Biologic Licensing Application
VEGZELMA- BEVACIZUMAB-ADCD INJECTION, SOLUTION CELLTRION USA, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE VEGZELMA SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VEGZELMA. VEGZELMA (BEVACIZUMAB-ADCD) INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 2022 VEGZELMA (BEVACIZUMAB-ADCD) IS BIOSIMILAR TO AVASTIN (BEVACIZUMAB). INDICATIONS AND USAGE VEGZELMA is a vascular endothelial growth factor inhibitor indicated for the treatment of: Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment. (1.1) Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine- oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first- line bevacizumab product-containing regimen. (1.1) Limitations of Use: VEGZELMA is not indicated for adjuvant treatment of colon cancer. (1.1) Unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment. (1.2) Recurrent glioblastoma in adults. (1.3) Metastatic renal cell carcinoma in combination with interferon alfa. (1.4) Persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel and cisplatin, or paclitaxel and topotecan. (1.5) Epithelial ovarian, fallopian tube, or primary peritoneal cancer: in combination with carboplatin and paclitaxel, followed by VEGZELMA as a single agent, for stage III or IV disease following initial surgical resection (1.6) in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease who received no more than 2 prior chemotherapy regimens (1.6) in combination with carboplatin and paclitaxel or carboplatin and gemcitabine, followed by VEGZELMA as a single agent, for platinum-sensitive recurrent disease (1.6) DOSAGE AND ADMINISTRATION Withhold for Đọc toàn bộ tài liệu