复方曲氟尿苷盐酸/替吡嘧啶片LONSURF 15/6.14MG TAB

药店国别： 产地国家：美国 处方药：是 所属类别： 15毫克/6.14毫克/片 40片/瓶 包装规格： 15毫克/6.14毫克/片 40片/瓶 计价单位：瓶 生产厂家中文参考译名： 生产厂家英文名：TAIHO ONCOLOGY INC 原产地英文商品名：LONSURF 15/6.14MG TAB 40/EA 原产地英文药品名：trifluridine and tipiracil 中文参考商品译名：Lonsurf复方片 15毫克/6.14毫克/片 40片/瓶 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：TaihoOncology，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： 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。 包装供应/贮存和处置供应 LONSURF15mg/6.14mg片以白色，双凸，圆，薄膜衣片，在一侧以灰色汁印有‘15’，和另一侧‘102’和’15mg’供应。这个片被包装在HDPE瓶带有防儿童密闭盖以下列外观：●20数量：NDC 64842-1025-1●40数量：NDC 64842-1025-2●60数量：NDC 64842-1025-3LONSURF20mg/8.19mg片是以淡红色，双凸，圆，薄膜衣片，在一侧用灰汁印有‘20’，和另一侧‘102’和‘20mg’供应。该片被包装在HDPE瓶有防儿童密闭盖以下列外观：●20数量：NDC64842-1020-1●40数量：NDC 64842-1020-2●60数量：NDC 64842-1020-3 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

(trifluridine and tipiracil) tabletsIMPORTANT SAFETY INFORMATIONLONSURF maycause serious side effects, including:Low blood counts. Low blood counts arecommon with LONSURF and can sometimes be severe and life‑threatening. LONSURFcan cause a decrease in your white blood cells, red blood cells, and platelets.Low white blood cells can make you more likely to get serious infections thatcould lead to death. Your healthcare provider should do blood tests before youreceive LONSURF, at day 15 during treatment with LONSURF, and as needed to checkyour blood cell counts. Your healthcare provider may lower your dose of LONSURFor stop LONSURF if you have low white blood cell or platelet countsTell yourhealthcare provider right away ifyou get any of the following signs andsymptoms of infection during treatment with LONSURF: fever, chills, or bodyaches.Before taking LONSURF, tell your healthcare provider about all of yourmedical conditions, including if you:Have kidney or liver problemsAre pregnantor plan to become pregnant. LONSURF can harm your unborn babyFemales who canbecome pregnant should use effective birth control during treatment withLONSURF. Tell your healthcare provider immediately if you become pregnantMales,while on treatment and for 3 months after your last dose of LONSURF, you shoulduse a condom during sex with female partners who are able to become pregnant.Tell your healthcare provider right away if your partner becomes pregnant whileyou are taking LONSURFAre breast‑feeding or plan to breast‑feed. It is not knownif LONSURF passes into your breast milk. Do not breast‑feed during treatmentwith LONSURF and for 1 day after your last dose of LONSURFTell your healthcareprovider about all the prescription and over‑the‑counter medicines, vitamins,and herbal supplements you take.The most common side effects with LONSURFinclude tiredness, nausea, decreased appetite, diarrhea, vomiting, abdominalpain, and fever.Tell your doctor if you have nausea, vomiting, or diarrhea thatis severe or that does not go away.These are not all of the possible sideeffects of LONSURF. For more information, ask your healthcare provider. Callyour doctor for medical advice about side effects.