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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: 100毫克 30片/瓶
计价单位:
  点击放大  
生产厂家英文名:
Pfizer Laboratories Div Pfizer Inc
该药品相关信息网址1:
https://www.lorbrena.com/
原产地英文商品名:
Lorbrena 100mg 30tab/box
原产地英文药品名:
lorlatinib
中文参考商品译名:
劳拉替尼 100毫克 30片/瓶
中文参考药品译名:
lorlatinib
原产地国家批准上市年份:
2018/11/19
英文适应病症1:
for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on
临床试验期:
完成
中文适应病症参考翻译1:
间变性淋巴瘤激酶(ALK)阳性转移性非小细胞肺癌(NSCLC)
药品信息:

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详细处方信息以本药内容附件PDF文件(201951420402319.pdf)的“原文Priscribing Information”为准
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部分中文Lorbrena处方资料(仅供参考)

【英文名称】Lorbrena

【适用证】

LORBRENA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,该疾病已在疾病进展

--- crizotinib和至少一种其他ALK抑制剂用于转移性疾病; 要么

--- alectinib作为第一种ALK抑制剂治疗转移性疾病; 要么

--- ceritinib作为第一种ALK抑制剂治疗转移性疾病。

根据肿瘤反应率和反应持续时间,该指征在加速批准下获得批准。 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。(1)

【用法用量】

推荐剂量为每日口服100毫克。(2.1)

【禁忌】

与强CYP3A诱导剂同时使用。(4)

【使用注意】

伴随使用强CYP3A诱导剂的严重肝毒性风险:在启动LORBRENA之前,停用强CYP3A诱导剂治疗强CYP3A诱导剂的3个血浆半衰期。 (2.3,5.1) 中枢神经系统(CNS)的影响:中枢神经系统的影响包括癫痫发作,幻觉和认知功能的改变,情绪(包括自杀意念),言语,心理状态和睡眠。以相同或减少的剂量扣留并恢复LORBRENA或根据严重程度永久停止LORBRENA。 (2.2,5.2)

高脂血症:开始或增加降脂药的剂量。根据严重程度,以相同或减少的剂量扣留并恢复LORBRENA。 (2.2,5.3)

房室传导阻滞:根据严重程度,以相同或减少剂量停用并恢复LORBRENA。 (2.2,5.4)

间质性肺病/肺炎:在怀疑患有ILD /肺炎的患者中立即停用LORBRENA。永久停止LORBRENA治疗任何严重程度的ILD /肺炎。 (2.2,5.5)

胚胎 - 胎儿毒性:可能导致胎儿伤害。告知女性对胎儿有潜在风险的生殖潜力。建议具有生殖潜力的男性和女性使用有效的非激素避孕方法。 (5.6,7.2,8.1,8.3)

【INDICATIONS AND USAGE】

LORBRENA is a kinase inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on

---crizotinib and at least one other ALK inhibitor for metastatic disease; or

---alectinib as the first ALK inhibitor therapy for metastatic disease; or

---ceritinib as the first ALK inhibitor therapy for metastatic disease.

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)

【CONTRAINDICATIONS】

Concomitant use with strong CYP3A inducers. (4)

【WARNINGS AND PRECAUTIONS】

Risk of Serious Hepatotoxicity with Concomitant Use of Strong CYP3A Inducers: Discontinue strong CYP3A inducers for 3 plasma half-lives of the strong CYP3A inducer prior to initiating LORBRENA. (2.3, 5.1)

Central Nervous System (CNS) Effects: CNS effects include seizures, hallucinations and changes in cognitive function, mood (including suicidal ideation), speech, mentalstatus, and sleep. Withhold and resume LORBRENA at same or reduced dose or permanently discontinue LORBRENA based on severity. (2.2, 5.2)

Hyperlipidemia: Initiate or increase the dose of lipid-lowering agents. Withhold and resume LORBRENA at same or reduced dose based on severity. (2.2, 5.3)

Atrioventricular Block: Withhold and resume LORBRENA at same or reduced dose based on severity. (2.2, 5.4)

Interstitial Lung Disease/Pneumonitis: Immediately withhold LORBRENA in patients with suspected ILD/pneumonitis. Permanently discontinue LORBRENA for treatment-related ILD/pneumonitis of any severity. (2.2, 5.5)

Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus. Advise males and females of reproductive potential to use an effective non-hormonal method of contraception. (5.6, 7.2, 8.1, 8.3)

【DOSAGE AND ADMINISTRATION】

The recommended dosage is 100 mg orally once daily. (2.1)

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详细处方信息以本药内容附件PDF文件(201951420402319.pdf)的“原文Priscribing Information”为准
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更新日期: 2019-6-6
附件:
201951420402319.pdf    

 
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