卡莫司汀植入膜剂 Polifeprosan 20with Carmustine 商品名GLIADEL WAFER 美德意日产品，一次性进口，平价供应
英文名：Polifeprosan 20with Carmustine
商标名：GLIADEL WAFER
中文名：卡莫司汀植入膜剂
剂 型：脑内用胶粉晶片
生产商：ARBOR PHARMACEUTICALS INC
上市国家：美国
包装[注：以下是美国产品。欧洲及日本等产品均可采购，采购以咨询为准]
7.7毫克/片 8片/盒
GLIADEL WAFER-KEEP FROZEN 1/PAC POLIFEPROSAN 20/CARMUSTINE ARBOR PHARMACEUTICALS INC 24338-0050-08 $49,421.64
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美国FDA于1996年批准Guilford公司研发，以BCNU为活性成分，聚苯丙生20为释放基质，制成植入药物芯片Gliadel，治疗复发性恶性脑瘤，可在手术后，将药物直接放置于复发性恶性胶质细胞瘤之脑组织中，让药物缓慢释放，进行持续性化学治疗。经过多年多中心临床试验，FDA于2003年加大其治疗适应症，批准Gliadel用于原发性恶性脑瘤的治疗，据文献报道，Gliadel可延长原发性及复发性恶性脑瘤患者的中间存活期。
该治疗方法的独特之处在于其给药方式及释放系统。在外科手术过程中，先将肿瘤组织切除，留下一个小空腔，然后植入这种定期释放的芯片。这些芯片会在2~3周之内慢慢地分解、融化，释放出的药物可直接进入肿瘤区，杀死那些在外科手术中没有切除干净的肿瘤细胞，并且能在不损害其它组织的情况下使病变局部能达到有效的血药浓度，延缓了疾病的进展。
美国癌症中心联盟(National Comprehensive Cancer Network, NCCN)针对恶性脑瘤的最新治疗原则中指出，原发及复发恶性脑瘤患者皆可予以手术切除肿瘤时同时置入Gliadel(BCNU)，术后辅以放射线治疗或Temozolomide等化疗药物治疗，据文献报道，采用此治疗模式可有效延长患者的存活中位数。
批准日期：1996年 公司：ARBOR PHARMACEUTICALS INC
GLIADEL WAFER (卡莫司汀[carmustine implant])植入物， 脑内用胶粉晶片
美国最初批准:1996年
作用机制
GLIADEL Wafer活性的升高是由于肿瘤切除腔内释放出carmustine(一种DNA和RNA烷基化剂)的细胞毒性浓度。在切除腔的水环境中，共聚物中的茶酐键被水解，释放出卡莫司汀、羧基苯氧丙烷和癸二酸进入周围的脑组织。
适应症和用法
GLIADEL Wafer是一种用于治疗:
•新诊断的高等级恶性胶质瘤作为外科手术和放疗的辅助手段。复发性多型胶质母细胞瘤作为外科手术的辅助治疗。
剂量和管理
•推荐剂量:8片7.7mg晶圆片(总剂量61.6mg)植入颅内。
•遵循准备和处理建议。
剂型及强度
•每个GLIADEL晶圆片含有7.7毫克carmustine。
禁忌症
没有
警告和预防措施
•癫痫发作:监测患者植入后的癫痫发作情况。
•颅内压升高:监测患者颅内压升高的迹象。神经外科伤口愈合受损:监测患者开颅手术并发症。
•脑膜炎:监测患者是否有细菌性或化学性脑膜炎症状。
•晶片迁移:监测患者是否有阻塞性脑积水的迹象。
胚胎-胎儿毒性:可导致胎儿伤害。
不良反应
•最近确诊高档恶性神经胶质瘤:最常见的不良反应(发生率≥4%)> 10%,betweenarm区别是脑水肿、无力、恶心、呕吐、便秘、伤口愈合abnormalitiesand萧条。
•多形性成胶质细胞瘤复发:最常见的不良反应(发生率> 10%和手臂之间差异≥4%)是尿路感染,伤口healingabnormalities和发热。
要报告疑似不良反应，请联系Arbor Pharmaceuticals, LLC(电话:1-866-516-4950)或FDA(电话:1-800-FDA-1088)或www.fda.gov/medwatch。
用于特定人群
•儿科使用:安全性和有效性尚未确定。
包装提供/存储和处理
GLIADEL晶圆片装在一个单剂量处理盒中，包含8个单独的袋状晶圆片。每个晶圆片含有7.7毫克卡莫司汀，包装在两个铝箔层压板袋中。内袋是无菌的，旨在保持产品的无菌性和保护产品的水分。外袋是一层可剥的外皮。外袋的外表面不是无菌的。
单剂量治疗盒NDC: 24338-050-08
商店GLIADEL晶片达到或者低于-20ºC(4ºF)。
在30天内，不可将未开封的箔袋在室温下保存超过6小时，每次最多可保存3周。
GLIADEL Wafer是一种细胞毒性药物，需要考虑特殊处理和处理流程。
完整资料附件：
1）：http://gliadel.com/hcp/
2）：http://gliadel.com/hcp/media/_pdfs/prescribing-information-gliadel.pdf
3）：
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=38962a55-a514-4c48-bea5-f99a8da4beec
GLIADEL WAFER(carmustine implant) for intracranial use
IMPORTANT SAFETY INFORMATION
GLIADEL Wafer can cause fetal harm when administered to a pregnant woman. It is recommended that patients receiving GLIADEL Wafer discontinue nursing. Female patients of reproductive potential should receive counseling on pregnancy planning and prevention. Advise male patients of the potential risk of infertility, and to seek counseling on fertility and family planning options prior to implantation of GLIADEL Wafer.
WARNINGS AND PRECAUTIONS
Seizures: Fifty-four percent (54%) of patients treated with GLIADEL Wafers in the recurrent disease trial experienced new or worsened seizures within the first five post-operative days. The median time to onset of the first new or worsened post-operative seizure was 4 days. Optimize anti-seizure therapy prior to surgery. Monitor patients for seizures postoperatively.
Intracranial Hypertension: Brain edema occurred in 23% of patients treated with GLIADEL Wafers in the initial surgery trial. Additionally, one GLIADEL-treated patient experienced intracerebral mass effect unresponsive to corticosteroids which led to brain herniation. Monitor patients closely for intracranial hypertension related to brain edema, inflammation, or necrosis of the brain tissue surrounding the resection. In refractory cases, consider re-operation and removal of GLIADEL Wafers or Wafer remnants.
Impaired Neurosurgical Wound Healing: Impaired neurosurgical wound healing including wound dehiscence, delayed wound healing, and subdural, subgleal, or wound effusions occur with GLIADEL Wafer treatment. In the initial disease trial, 16% of GLIADEL Wafer-treated patients experienced impaired intracranial wound healing and 5% had cerebrospinal fluid leaks. In the recurrent disease trial, 14% of GLIADEL Wafer-treated patients experienced wound healing abnormalities. Monitor patients post-operatively for impaired neurosurgical wound healing.
Meningitis: Meningitis occurred in 4% of patients receiving GLIADEL Wafers in the recurrent disease trial. Two cases of meningitis were bacterial; one patient required removal of the Wafers four days after implantation; the other developed meningitis following reoperation for recurrent tumor. One case was diagnosed as chemical meningitis and resolved following steroid treatment. In one case the cause was unspecified, but meningitis resolved following antibiotic treatment. Monitor postoperatively for signs of meningitis and central nervous system infection.
Wafer Migration: GLIADEL Wafer migration can occur. To reduce the risk of obstructive hydrocephalus due to wafer migration into the ventricular system, close any communication larger than the diameter of a Wafer between the surgical resection cavity and the ventricular system prior to Wafer implantation. Monitor patients for signs of obstructive hydrocephalus.
ADVERSE REACTIONS
The most common adverse reactions in Newly-Diagnosed High Grade Malignant Glioma patients (incidence >10% and between arm difference ≥4%) are cerebral edema, asthenia, nausea, vomiting, constipation, wound healing abnormalities and depression.
The most common adverse reactions in Recurrent Glioblastoma Multiforme patients (incidence >10% and between arm difference ≥4%) are urinary tract infection, wound healing abnormalities and fever. |
