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  药店国别: 美国药房
产地国家: 美国
所属类别: 抗癌药物->治疗肺癌药物
处方药:处方药
包装规格: 400毫克 10小瓶/盒
计价单位:
  点击放大  
生产厂家中文参考译名:
美国千禧制药公司
生产厂家英文名:
Millennium Pharmaceuticals, Inc.
该药品相关信息网址1:
https://www.alunbrig.com/hcp?utm_source=google&utm_medium=cpc&utm_term=alunbrig&utm_campaign=GS%2B-%2B2018%2B-%2BBR%2B-%2BBranded%2B-%2BHCP_GS%2B-%2BBrand%2BAlone_PH
原产地英文商品名:
Alunbrig 30mg 30 FILM COATED tabs/bottle
原产地英文药品名:
brigatinib
中文参考商品译名:
布吉他滨 30毫克 30片薄膜衣片剂/盒
中文参考药品译名:
布吉替尼
原产地国家批准上市年份:
2017/04/28
英文适应病症1:
patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib
临床试验期:
完成
中文适应病症参考翻译1:
变性淋巴瘤激酶(ALK)阳性转移性非小细胞肺癌(NSCLC)患者
药品信息:

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 详细处方信息以本药内容附件PDF文件(201911414112940.pdf)的“原文Priscribing Information”为准
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 部分中文布吉他滨处方资料(仅供参考)


【英文名称】
Alunbrig


【中文名称】
吉他滨

【适用证】

ALUNBRIG是一种激酶抑制剂,适用于治疗间变性淋巴瘤激酶(ALK)阳性转移性非小细胞肺癌(NSCLC)患者,这些患者已进展或对克唑替尼不耐受。 根据肿瘤反应率和反应持续时间,在加速批准下批准该适应症。 对该指征的持续批准可能取决于验证试验中的临床益处的验证和描述。
 

【用法用量】

前7天每天口服90毫克; 如果耐受,每天口服一次,增加至180毫克。 可以带或不带食物。
 

【警告和注意事项】

•间质性肺病(ILD)/肺炎:

在推荐剂量的9.1%患者中发生。监测新的或恶化的呼吸道症状,特别是在治疗的第一周。扣留ALUNBRIG新的或恶化的呼吸道症状并及时评估ILD /肺炎。恢复后,剂量减少或永久停止ALUNBRIG。 (2.2,5.1)

•高血压:

2周后监测血压,然后在治疗期间至少每月监测一次血压。对于严重的高血压,扣留 ALUNBRIG,然后剂量减少或永久停止。 (2.2,5.2)

•心动过缓:

在治疗期间定期监测心率和血压。如果有症状,扣留ALUNBRIG,则剂量减少或永久停药。 (2.2,5.3)

•视觉障碍:

建议患者报告视觉症状。扣留ALUNBRIG并获得眼科评估,然后剂量减少或永久停止ALUNBRIG。 (2.2,5.4)

【INDICATIONS AND USAGE】

ALUNBRIG is a kinase inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. (1, 14).
 

【DOSAGE AND ADMINISTRATION】

90 mg orally once daily for the first 7 days; if tolerated, increase to 180 mg orally once daily. May be taken with or without food. (2.1)
 

【WARNINGS AND PRECAUTIONS】

• Interstitial Lung Disease (ILD)/Pneumonitis:

Occurred in 9.1% of patients at the recommended dose. Monitor for new or worsening respiratory symptoms, particularly during the first week of treatment. Withhold ALUNBRIG for new or worsening respiratory symptoms and promptly evaluate for ILD/pneumonitis. Upon recovery, either dose reduce or permanently discontinue ALUNBRIG. (2.2, 5.1)

• Hypertension:

Monitor blood pressure after 2 weeks and then at least monthly during treatment. For severe hypertension, withhold ALUNBRIG, then dose reduce or permanently discontinue. (2.2, 5.2)

• Bradycardia:

Monitor heart rate and blood pressure regularly during treatment. If symptomatic, withhold ALUNBRIG, then dose reduce or permanently discontinue. (2.2, 5.3)

• Visual Disturbance:

Advise patients to report visual symptoms. Withhold ALUNBRIG and obtain ophthalmologic evaluation, then dose reduce or permanently discontinue ALUNBRIG. (2.2, 5.4)
 

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 详细处方信息以本药内容附件PDF文件(201911414112940.pdf)的“原文Priscribing Information”为准
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更新日期: 2019-1-14
附件:
201911414112940.pdf    

 
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