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  药店国别: 德国药房
产地国家: 德国
所属类别: 抗癌药物->治疗肺癌药物
处方药:处方药
包装规格: 40毫克 28薄膜包衣片/盒
计价单位:
   
生产厂家英文名:
Boehringer Ingelheim
该药品相关信息网址1:
http://www.giotrif.com/
原产地英文商品名:
Giotrif 40mg 28coated tab/box
原产地英文药品名:
Afatinib
中文参考商品译名:
Giotrif 40毫克 28薄膜包衣片/盒
中文参考药品译名:
阿法替尼片
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Lung cancer
临床试验期:
完成
中文适应病症参考翻译1:
肺癌
药品信息:

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详细处方信息以本药内容附件PDF文件(20193912464330.pdf)的“原文Priscribing Information”为准
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部分中文GILOTRIF处方资料(仅供参考)


【英文名称】
GILOTRIF

【适用证】

GILOTRIF是一种激酶抑制剂,适用于:

转移性非小细胞肺癌(NSCLC)患者的一线治疗,其肿瘤具有非抗性表皮生长因子受体(EGFR)突变,经FDA批准的检测(1.1)使用限制: 肿瘤具有抗EGFR突变的患者未建立GILOTRIF的安全性和有效性(1.1)

铂类化疗后转移性鳞状NSCLC患者的治疗(1.2)

【用法用量】

推荐剂量:口服40毫克,每日一次(2.2)

肾功能损害:口服30 mg,严重肾功能不全患者每日一次(2.2,8.6,12.3)

指导患者在餐前至少1小时或餐后2小时服用GILOTRIF(2.2)

【警告和注意事项】

腹泻:腹泻可能导致脱水和肾功能衰竭。扣留GILOTRIF治疗严重和长期腹泻,对止泻药无反应。 (2.3,5.1)

大疱性和剥脱性皮肤病:0.2%的患者出现严重的大疱,水疱和去角质病变。停止危及生命的皮肤反应。扣留GILOTRIF用于严重和持久的皮肤反应。 (2.3,5.2)

间质性肺病(ILD):1.6%的患者发生。扣留GILOTRIF导致肺部症状急性发作或恶化。如果诊断出ILD,则停止GILOTRIF。 (2.3,5.3)

肝毒性:0.2%的患者发生致命性肝损伤。通过定期肝脏检测进行监测扣留或停止GILOTRIF用于严重或恶化的肝脏检查。 (2.3,5.4)

角膜炎:0.7%的患者发生。扣留GILOTRIF进行角膜炎评估。扣留或停止GILOTRIF确认溃疡性角膜炎。 (2.3,5.5)

胚胎 - 胎儿毒性:给孕妇服用会导致胎儿伤害。建议孕妇和女性对胎儿的潜在风险和使用有效避孕的生殖潜力。 (5.6)

【INDICATIONS AND USAGE】

GILOTRIF is a kinase inhibitor indicated for:

 First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test (1.1) Limitation of Use: Safety and efficacy of GILOTRIF were not established in patients whose tumors have resistant EGFR mutations (1.1)

 Treatment of patients with metastatic, squamous NSCLC progressing after platinum-based chemotherapy (1.2)

【DOSAGE AND ADMINISTRATION】

Recommended dose: 40 mg orally, once daily (2.2)

 Renal impairment: 30 mg orally, once daily in patients with severe renal impairment (2.2, 8.6, 12.3)

 Instruct patients to take GILOTRIF at least 1 hour before or 2 hours after a meal (2.2)

【WARNINGS AND PRECAUTIONS】

 Diarrhea: Diarrhea may result in dehydration and renal failure. Withhold GILOTRIF for severe and prolonged diarrhea not responsive to antidiarrheal agents. (2.3, 5.1)

 Bullous and exfoliative skin disorders: Severe bullous, blistering, and exfoliating lesions occurred in 0.2% of patients. Discontinue for lifethreatening cutaneous reactions. Withhold GILOTRIF for severe and prolonged cutaneous reactions. (2.3, 5.2)

 Interstitial lung disease (ILD): Occurs in 1.6% of patients. Withhold GILOTRIF for acute onset or worsening of pulmonary symptoms. Discontinue GILOTRIF if ILD is diagnosed. (2.3, 5.3)

 Hepatic toxicity: Fatal hepatic impairment occurs in 0.2% of patients. Monitor with periodic liver testing. Withhold or discontinue GILOTRIF for severe or worsening liver tests. (2.3, 5.4)

 Keratitis: Occurs in 0.7% of patients. Withhold GILOTRIF for keratitis evaluation. Withhold or discontinue GILOTRIF for confirmed ulcerative keratitis. (2.3, 5.5)

 Embryo-fetal toxicity: Can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to the fetus and to use effective contraception. (5.6)

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详细处方信息以本药内容附件PDF文件(20193912464330.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------

更新日期: 2019-3-6
附件:
20193912464330.pdf    

 
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