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当前本网站药物产品种数共 8524 处方药 8148 非处方药 269 保健品/医疗用具 107

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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->治疗肾癌药物
处方药:处方药
包装规格: 5毫克/片 60片/瓶
计价单位:
  点击放大  
生产厂家中文参考译名:
辉瑞
生产厂家英文名:
PFIZER
该药品相关信息网址1:
http://www.inlyta.com/
该药品相关信息网址2:
http://www.drugs.com/inlyta.html
该药品相关信息网址3:
http://www.rxlist.com/inlyta-drug.htm
原产地英文商品名:
INLYTA 5MG/TAB 60TABS/BOTTLE (Controlled; can only sell to oncology centers and hospitals)
原产地英文药品名:
AXITINIB
中文参考商品译名:
INLYTA 5毫克/片 60片/瓶 (Controlled; can only sell to oncology centers and hospitals)
中文参考药品译名:
阿西替尼
原产地国家批准上市年份:
2012/01/27
英文适应病症1:
Renal cell carcinoma
临床试验期:
完成
中文适应病症参考翻译1:
肾细胞癌
药品信息:

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 详细处方信息以本药内容附件PDF文件(201232922122828.pdf)的“原文Priscribing Information”为准
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部分中文阿西替尼处方资料(仅供参考)

FDA批准Inlyta (阿西替尼axitinib)用于治疗晚期肾细胞癌
    2012年1月27日,美国食品药品监督管理局批准Inlyta (阿西替尼)用于治疗其他药物治疗无效的晚期肾癌(肾细胞癌)。
    肾细胞癌是肾癌的一种,始于肾小管内层。Inlyta是一日服用两次的片剂,通过阻断激酶蛋白起到抑制肿块生长和癌症进展。
    对723名经前期系统治疗但在治疗期或治疗后疾病仍有进展的患者,进行随机、无盲、多中心临床试验评估了该药的安全性和有效性。研究衡量患者无进展生存时间,结果显示:与标准治疗(索拉非尼)4.7个月的中位无进展存活期相比,Inlyta的中位无进展存活期为6.7个月。
    在临床研究中观察到的最常见(大于20%的患者)副作用为腹泻、高血压、疲劳、食欲减退、恶心、失音(言语困难)、手-足综合征、体重减轻、呕吐、虚弱和便秘。
    高血压患者在服用Inlyta前应加以良好控制。一些患者在服用Inlyta后出现了出血问题,这在一些病例中是致命的。未经治疗的脑瘤或胃肠道出血患者不应服用Inlyta。

美国初次批准:2012 年

适应证和用途
INLYTA 是一种激酶抑制剂适用于一种既往全身治疗失败后晚期肾细胞癌的治疗。

剂量和给药方法
(1)开始剂量为5 mg口服每天2次。可根据个体安全性和耐受性调整剂量。
(2)约间隔12小时给予INLYTA剂量有或无食物。
(3)INLYTA应与一杯水整片吞服。
(4)如需要强CYP3A4/5抑制剂,减低INLYTA 剂量约半量.
(5)对中度肝受损患者,减低开始剂量约半量。

剂型和规格
1 mg和5 mg片。

禁忌证
无。

警告和注意事项
(1)曾观察到高血压包括高血压危象。开始INLYTA前应充分控制血压。需要监视和治疗高血压。尽管使用抗高血压药物,对持续高血压减低INLYTA剂量。
(2)曾观察到动脉和静脉血栓事件和可能致死。对这些事件风险增加患者慎用。
(3)曾报道出血事件, 包括致命性事件。尚未在未治疗脑转移或最近活动性胃肠道出血证据患者中研究过INLYTA和在这些患者中不应使用。
(4)曾发生胃肠道穿孔和瘘管,包括死亡。对胃肠道穿孔或瘘管风险患者慎用。
(5)曾报道甲状腺低下症需要甲状腺激素替代。用NLYTA治疗开始前监视甲状腺功能,和自始至终定期。
(6)计划手术前至少24小时停止INLYTA。
(7)曾观察到可逆性后部白质脑病综合征(RPLS)。如发生RPLS体征或症状永久终止INLYTA。
(8)用INLYTA治疗开始前,和自始至终定期监视蛋白尿。对中度至严重蛋白尿,减低剂量或暂时中断用INLYTA治疗。
(9)用INLYTA治疗时曾观察到肝酶升高。用INLYTA治疗开始前和自始至终定期监视ALT,AST和胆红素。
(10)中度肝受损患者如使用INLYTA开始剂量应减低。严重肝受损患者中未曾研究过INLYTA。
(11)当给予妊娠妇女根据其作用机制INLYTA可能致胎儿危害。应忠告生育能力妇女对胎儿潜在危害和当接受INLYTA避免成为妊娠。

不良反应
最常见(≥20%)不良反应是腹泻,高血压,疲乏,食欲减低,恶心,发音障碍,手掌-足底erythrodysesthesia (手-足)综合征,体重减轻,呕吐,乏力,和便秘。

药物相互作用
(1)避免强CYP3A4/5抑制剂。如不可避免,减低INLYTA 剂量。
(2)避免强CYP3A4/5诱导剂。

如何供应/贮存和储置
INLYTA片供应如下:
1 mg片是红色膜衣,椭圆片一侧凹有“Pfizer”和另一侧“1 XNB”;得到80片瓶: NDC 0069-0145-01。
5 mg片是红色膜衣,三角形一侧凹有“Pfizer”和另一侧“5 XNB”;得到60片瓶:: NDC 0069-0151-11.
贮存在20°C至25°C(68°F至77°F);外出允许15°C至30°C(59°F至86°F)[见USP 控制室温]。

Drug Name: Inlyta (axitinib)
Company: Pfizer
Approval Status: Approved January 2012
Treatment Area: advanced renal cell carcinoma

General Information
Inlyta (axitinib) is a kinase inhibitor. It has been shown to inhibit receptor tyrosine kinases including vascular endothelial growth factor receptors (VEGFR)-1, VEGFR-2, and VEGFR-3. These receptors are implicated in pathologic angiogenesis, tumor growth, and cancer progression.

Inlyta was specifically approved for the treatment of advanced renal cell carcinoma after failure of one prior systemic therapy.

Inlyta is supplied as a tablet for oral administration. The recommended starting dose of Inlyta is 5 mg twice daily. Doses should be administered approximately 12 hours apart with or without food. The tablet should be swallowed whole with a glass of water. If the patient vomits or misses a dose, an additional dose should not be taken. The next prescribed dose should be taken at the usual time. If the initial dose is well tolerated after two weeks, the Inlyta dose may be increased. When a dose increase from 5 mg twice daily is recommended, the Inlyta dose may be increased to 7 mg twice daily, and further to 10 mg twice daily using the same criteria. If dose reduction from 5 mg twice daily is required, the recommended dose is 3 mg twice daily. If additional dose reduction is required, the recommended dose is 2 mg twice daily.

Clinical Results
FDA Approval
The FDA approval of Inlyta was based on a randomized, open-label, multicenter phase III study. A total of 723 subjects with advanced RCC whose disease had progressed on or after treatment with one prior systemic therapy were randomized to receive Inlyta or sorafenib (Nexavar- current standard of care). The primary endpoint was progression free survival (PFS). There was a statistically significant advantage for Inlyta over sorafenib for the endpoint of PFS. The median PFS in the Inlyta treatment arm was 6.7 months versus 4.7 months in the sorafenib arm (p<0.0001).

Side Effects
Adverse events associated with the use of Inlyta may include, but are not limited to, the following:
•diarrhea
•hypertension
•fatigue
•decreased appetite
•nausea
•dysphonia
•palmar-plantar erythrodysesthesia (hand-foot) syndrome
•weight decreased
•vomiting
•asthenia
•constipation

Mechanism of Action
Inlyta (axitinib) is a kinase inhibitor. It has been shown to inhibit receptor tyrosine kinases including vascular endothelial growth factor receptors (VEGFR)-1, VEGFR-2, and VEGFR-3 at therapeutic plasma concentrations. These receptors are implicated in pathologic angiogenesis, tumor growth, and cancer progression.

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 详细处方信息以本药内容附件PDF文件(201232922122828.pdf)的“原文Priscribing Information”为准
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更新日期: 2016-07-16
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