曲氟尿苷盐酸/替吡嘧啶复合片(LONSURF 15/6.14MG TAB)

产地国家美国

处方药

所属类别 15毫克/6.14毫克/片 20片/盒

包装规格 15毫克/6.14毫克/片 20片/盒

计价单位

生产厂家英文名TAIHO ONCOLOGY INC

原产地英文商品名LONSURF 15/6.14MG TAB 20/EA

原产地英文药品名trifluridine and tipiracil hydrochloride

中文参考商品译名LONSURF复合片 15毫克/6.14毫克/片 20片/盒

中文参考药品译名曲氟尿苷盐酸/替吡嘧啶

简介

近日,美国食品药品监督管理局(FDA)批准了Lonsurf用于对其他治疗无应答的晚期结直肠癌患者(NEJM:TAS-102对难治性转移性结直肠癌的临床效果)(RECOURSE试验III期:TAS-102对比安慰剂治疗已给予最佳支持治疗且能耐受标准化疗的mCRC患者)。Lonsurf是一种口服药,是三氟胸苷和 tipiracil 盐酸盐片,又称TAS-102,用于治疗已经化疗和生物治疗的晚期(转移性)结直肠癌患者。批准日期:2015年9月22日;公司:Taiho Oncology,Inc.LONSURF(曲氟尿苷盐酸/替吡嘧啶[TRIFLURIDINE/TIPIRACIL])片,为口服使用美国初次批准:2015

作用机制:LONSURF是基于胸苷核苷类似物,曲氟尿苷,和胸苷磷酸化酶抑制剂,tipiracil组成,在克分子浓度比值1:0.5(重量比值,1:0.471)。包括tipiracil通过胸苷磷酸化酶抑制其代谢增加曲氟尿苷暴露。摄入癌细胞后,曲氟尿苷背掺入至DNA,干扰DNA合成和抑制细胞增殖。曲氟尿苷/tipiracil在异种移植物小鼠显示对KRAS野生型和突变体人结肠直肠癌的抗肿瘤活性。

适应证和用途:LONSURF是曲氟尿苷,核苷代谢抑制剂,和tipiracil,胸苷磷酸化酶抑制剂,的联用适用为患者有转移结肠直肠癌以前治疗过用基于氟嘧啶[fluoropyrimidine]-,奥沙利铂[oxaliplatin]-和伊立替康[irinotecan]-化疗,一种抗-VEGF生物学治疗,和如RAS野生型,一种抗-EGFR治疗的治疗。

剂量和给药方法:⑴ 推荐剂量:35mg/m2/dose口服每天2次在每28天疗程第1至5天和第8至12 of天。⑵ 早晨和傍晚餐完成后1小时内服用LONSURF。

剂型和规格:片剂:⑴15mg 曲氟尿苷/6.14mg tipiracil⑵20mg 曲氟尿苷/8.19mg tipiracil

禁忌证:无。

警告和注意事项:⑴ 严重骨髓抑制:每个疗程前和第15天得到完全血细胞计数。根据临床指征减低剂量和/或保持LONSURF。⑵ 胚胎-胎儿毒性:可能发生胎儿危害。忠告妇女对胎儿潜在风险。

不良反应:最常见不良反应(≥10%)是贫血,中性粒细胞减少,虚弱/疲乏,恶心,血小板减少,食欲减退,腹泻,呕吐,腹痛,和发热。

特殊人群中使用:⑴ 哺乳:不要哺乳喂养。⑵ 老年人使用:3或4级中性粒细胞减少和血小板减少和3级贫血在患者65岁或以上接受LONSURF中更常发生。⑶ 肾受损:有中度肾受损患者对增加毒性可能需要剂量修饰。

贮存和处置:贮存在20°C至25°C(68°F至77°F);外出允许从15°C至30°C(59°F至86°F)[见USP控制室温]。 LONSURF是一种细胞毒药物。遵循适用专用处置和遗弃程序。1 如贮存在原始瓶在外面, 30天后遗弃。

英文版说明书

LONSURF(trifluridine and tipiracil) tabletsImportant Safety InformationWARNINGS AND PRECAUTIONSSevere Myelosuppression: In Study 1, LONSURF caused severe and life‑threatening myelosuppression (Grade 3‑4) consisting of anemia (18%), neutropenia (38%), thrombocytopenia (5%), and febrile neutropenia (3.8%). One patient (0.2%) died due to neutropenic infection. In Study 1, 9.4% of LONSURF‑treated patients received granulocyte‑colony stimulating factors.Obtain complete blood counts prior to and on day 15 of each cycle of LONSURF and more frequently as clinically indicated. Withhold LONSURF for febrile neutropenia, Grade 4 neutropenia, or platelets less than 50,000/mm3. Upon recovery, resume LONSURF at a reduced dose.Embryo‑Fetal Toxicity: LONSURF can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with LONSURF.USE IN SPECIFIC POPULATIONSLactation: It is not known whether LONSURF or its metabolites are present in human milk. There are no data to assess the effects of LONSURF or its metabolites on the breast‑fed infant or the effects on milk production. Because of the potential for serious adverse reactions in breast‑fed infants, advise women not to breast‑feed during treatment with LONSURF and for 1 day following the final dose.Male Contraception: Advise males with female partners of reproductive potential to use condoms during treatment with LONSURF and for at least 3 months after the final dose.Geriatric Use: Grade 3 or 4 neutropenia and thrombocytopenia and Grade 3 anemia occurred more commonly in patients 65 years or older who received LONSURF.Renal Impairment: Patients with moderate renal impairment may require dose modifications for increased toxicity. No patients with severe renal impairment were enrolled in Study 1.Hepatic Impairment: Patients with moderate or severe hepatic impairment were not enrolled in Study 1.ADVERSE REACTIONSMost Common Adverse Drug Reactions in Patients Treated With LONSURF (≥5%): The most common adverse drug reactions in LONSURF‑treated patients vs placebo‑treated patients with refractory mCRC, respectively, were asthenia/fatigue (52% vs 35%), nausea (48% vs 24%), decreased appetite (39% vs 29%), diarrhea (32% vs 12%), vomiting (28% vs 14%), abdominal pain (21% vs 18%), pyrexia (19% vs 14%), stomatitis (8% vs 6%), dysgeusia (7% vs 2%), and alopecia (7% vs 1%).Additional Important Adverse Drug Reactions: The following occurred more frequently in LONSURF‑treated patients compared to placebo: infections (27% vs 15%), and pulmonary emboli (2% vs 0%).Interstitial lung disease (0.2%), including fatalities, has been reported in clinical studies and clinical practice settings in Asia.Laboratory Test Abnormalities in Patients Treated With LONSURF: Laboratory test abnormalities in LONSURF‑treated patients vs placebo‑treated patients with refractory mCRC, respectively, were anemia (77% vs 33%), neutropenia (67% vs 1%), and thrombocytopenia (42% vs 8%).

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