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贝伐单抗生物仿制药Alymsys(bevacizumab)获FDA批准,治疗多种癌症的新药(二)
2022-05-06 14:55:58 来源: 作者: 【 】 浏览:1107次 评论:0
冷冻或摇晃小瓶或纸箱。
*生物仿制药是指生物仿制药的批准基于数据证明它与FDA批准的生物产品(称为参考产品)高度相似,并且生物仿制药产品与参考产品之间没有临床意义的差异。
ALYMSYS 的生物相似性已在其完整版中描述的使用条件(例如适应症、给药方案)、强度、剂型和给药途径方面得到证明处方信息.
请参阅随附的Alymsys完整处方信息:
https://amneal.com/wp-content/uploads/2022/04/Bevacizumab-Injection-PI-Rev-04-2022-00.pdf
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Amneal Achieves Second U.S.Biosimilars Approval with ALYMSYS(bevacizumab-maly)
ALYMSYS(bevacizumab-maly)in the U.S. 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.
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.
First-Line non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel.
Recurrent glioblastoma in adults.
Metastatic renal cell carcinoma in combination with interferon alfa.
Persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan.
Epithelial ovarian, fallopian tube, or primary peritoneal cancer, in combination with paclitaxel
Limitations of Use: ALYMSYS® is not indicated for adjuvant treatment of colon cancer.
ALYMSYS® IMPORTANT SAFETY INFORMATION includes warnings and precautions on severe and fatal hemorrhage; arterial and venous thromboembolic events; hypertension, hypertensive crisis, and hypertensive encephalopathy; renal injury, proteinuria, and nephrotic syndrome; posterior reversible encephalopathy syndrome; embryo-fetal toxicity; ovarian failure; congestive heart failure; gastrointestinal perforations and fistula; surgery and wound healing complications, and infusion-related reactions.
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