药品信息:
--------------------------------------------------------------- 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 --------------------------------------------------------------- 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)
--------------------------------------------------------------- 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 --------------------------------------------------------------- |