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 详细处方信息以本药内容附件PDF文件（20123617254126.pdf）的“原文Priscribing Information”为准
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部分中文Adcetris处方资料（仅供参考）

Adcetris是自1977年第一个被FDA-批准治疗霍杰金淋巴瘤和第一个专门适用于治疗ALCL的新药 。
ADCETRISTM (brentuximab vedotin)为静脉输注注射剂
美国初始批准： 2011

适应证和用途
ADCETRIS是一种CD30-导向抗体药物结合物适用于：
（1）霍杰金淋巴瘤患者用自身干细胞移植(ASCT)失败后或不是ASCT备选者患者至少2次既往多药化疗方案失败后的治疗。
（2）有系统性间变性大细胞淋巴瘤患者至少1次既往多药化疗方案失败后的治疗。
这些适应证是根据缓解率。可得到的资料没有证实用ADCETRIS报道患者结局或生存改善。

剂量和给药方法
（1）推荐剂量是1.8 mg/kg只作为历时30分钟静脉输注给药每3周1次。
（2）继续治疗直至最大16个疗程，疾病进展或不可接受的毒性。

剂型和规格
50 mg单次使用小瓶。

禁忌证
无。

警告和注意事项
（1）周边神经病变：治疗医生应监视患者 神经病变和据此开始剂量调整。
（2）输注反应：如发生输注反应，应中断输注和开始适当医药处理。如发生过敏反应，应立即终止输注和开始适当医药处理。(5.2).
（3）中性粒细胞减少：每次给ADCETRIS前监视完全血计数。如发生3或4级中性粒细胞减少，用延迟给药，减低或终止药物处理。(5.3).
（4）肿瘤溶解综合征：有迅速增殖肿瘤和高肿瘤负荷患者是处在肿瘤溶解综合征风险和应严密监视这些患者和采取适当措施。(5.4).
（5）Stevens-Johnson综合征：如发生Stevens-Johnson综合征，终止ADCETRIS和给予适当医药治疗。
（6）进行性多灶性白质脑病(PML)：曾报道一例致命性PML。
（7）妊娠中使用：可能发生胎儿危害。应忠告妊娠妇女对胎儿的潜在危害。

不良反应
最常见不良反应(≥20%)是中性粒细胞减少，周边感觉神经病变，疲乏，恶心，贫血，上呼吸道感染，腹泻，发热，皮疹，血小板减少， 咳嗽，和呕吐。

药物相互作用
正在接受强CYP3A4抑制剂患者同时用ADCETRIS应严密监视不良反应。

特殊人群中使用
无

Adcetris (brentuximab vedotin): Drug Safety Communication - Progressive Multifocal Leukoencephalopathy and Pulmonary Toxicity
AUDIENCE: Oncology, Hematology, Neurology

ISSUE: FDA notified healthcare professionals that two additional cases of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection that can result in death, have been reported with the lymphoma drug Adcetris (brentuximab vedotin). Due to the serious nature of PML, a new Boxed Warning highlighting this risk has been added to the drug label.

In addition, a new Contraindication warning was added against use of Adcetris with the cancer drug bleomycin due to increased risk of pulmonary (lung) toxicity.

The signs and symptoms of PML may develop over the course of several weeks or months. They may include changes in mood or usual behavior, confusion, thinking problems, loss of memory, changes in vision, speech, or walking, and decreased strength or weakness on one side of the body.

BACKGROUND: Adcetris (brentuximab vedotin) is used to treat Hodgkin lymphoma and a rare lymphoma known as systemic anaplastic large cell lymphoma. At the time of Adcetris' approval in August 2011, one case of PML was described in the Warnings and Precautions section of the label.

RECOMMENDATION: Patients who develop any signs and symptoms of PML should notify their healthcare professional immediately. Healthcare professionals should hold Adcetris dosing if PML is suspected and discontinue Adcetris if a diagnosis of PML is confirmed. See the Data Summary in the Drug Safety Communication for additional information.

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 详细处方信息以本药内容附件PDF文件（20123617254126.pdf）的“原文Priscribing Information”为准
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