【警告和注意事项】 strong>
•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)
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【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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