肺癌RET融合阳性靶向药普拉替尼(普吉华）获FDA准许！附说明书-价格-副功效
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">2023年8月9日，美国FDA<span style="color: black;">准许</span><strong style="color: blue;">普拉替尼</strong>上市，用于治疗转染原癌基因(RET)融合阳性的非小细胞肺癌（NSCLC）成年<span style="color: black;">病人</span>。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="//q0.itc.cn/images01/20240514/485d87e97d684f72af4a1feb2f450f7f.jpeg" style="width: 50%; margin-bottom: 20px;"></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">早在2020年9月4日，美国FDA依据ARROW<span style="color: black;">实验</span>的疗效和安全性数据，加速<span style="color: black;">准许</span>了普拉替尼用于NSCLC<span style="color: black;">病人</span>的适应证。<span style="color: black;">这次</span>常规<span style="color: black;">准许</span>时，<span style="color: black;">科研</span>数据有所更新。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">转染原癌基因（RET）是一种癌症驱动基因，其<span style="color: black;">重点</span>的致癌方式是基因融合和突变。</strong><span style="color: black;">因此呢</span>，RET融合突变<span style="color: black;">亦</span>是一种新的致癌基因变异类型，在多种肿瘤（<span style="color: black;">包含</span>肺癌在内）中被<span style="color: black;">发掘</span>。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">在NSCLC中，<span style="color: black;">已然</span><span style="color: black;">发掘</span>了<span style="color: black;">最少</span>12个融合RET伴侣基因，KIF5B-RET融合是最多见的，<span style="color: black;">另外</span>还有CCDC6-RET、NCOA4-RET等。NSCLC<span style="color: black;">病人</span>中RET基因融合其实并不多见，<strong style="color: blue;"><span style="color: black;">出现</span>几率仅为1%~2%</strong>，<span style="color: black;">平常</span>于<span style="color: black;">青春</span>、不吸烟的肺腺癌<span style="color: black;">病人</span>。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">普拉替尼由Blueprint Medicines<span style="color: black;">机构</span><span style="color: black;">研发</span>，基石药业于2018年6月<span style="color: black;">经过</span>合作<span style="color: black;">得到</span>了普拉替尼在大中华区的独家<span style="color: black;">研发</span>和<span style="color: black;">商场</span>化权利。<span style="color: black;">另外</span>，Blueprint Medicines和罗氏（Roche）正在<span style="color: black;">全世界</span>（不<span style="color: black;">包含</span>大中华地区）<span style="color: black;">一起</span><span style="color: black;">研发</span>普拉替尼。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;"><span style="color: black;">做为</span>国家一类新药<span style="color: black;">获准</span>上市的普吉华®(普拉替尼胶囊)，可用于治疗非小细胞肺癌(NSCLC)和甲状腺癌(TC)。</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">普拉替尼简要说明书：</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">药物</span>中文名：普拉替尼</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">药物</span>英文名：Pralsetinib</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">药物</span>中文商品名：普吉华</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">药物</span>英文商品名：Gavreto</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">药物</span>别名：普雷西替尼，帕拉西替尼</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">规格剂量：100mg*120粒</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">开发</span>代号：BLU-667</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">生产厂家：Blueprint Medicines/基石药业</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">中国上市时间：2021年3月23日在中国<span style="color: black;">获准</span>上市</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;"><span style="color: black;">医疗保险</span>报销<span style="color: black;">前提</span>：</strong>暂未纳入<span style="color: black;">医疗保险</span>，<strong style="color: blue;"><span style="color: black;">日前</span>普拉替尼的自费价格为60000元/盒（买一增一）。</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="//q3.itc.cn/images01/20240514/7674021119ba4ff3ac8a5e0fc5d663ea.jpeg" style="width: 50%; margin-bottom: 20px;"><span style="color: black;">普拉替尼胶囊 普吉华</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">适应症：</strong>用于RET基因融合阳性的局部晚期或转移性非小细胞肺癌（NSCLC）一线治疗、12岁以上<span style="color: black;">必须</span>全身治疗的晚期或转移性RET突变甲状腺髓样癌(MTC)<span style="color: black;">病人</span>和<span style="color: black;">必须</span>全身治疗且放射性碘难治性晚期或转移性RET融合阳性甲状腺癌<span style="color: black;">病人</span>。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">用法用量：</strong>成人<span style="color: black;">举荐</span>剂量为400毫克，<span style="color: black;">每日</span>空腹口服一次(<span style="color: black;">吃下</span>GAVRETO前<span style="color: black;">最少</span>2小时不<span style="color: black;">摄食</span>，<span style="color: black;">吃下</span>后<span style="color: black;">最少</span>1小时内不<span style="color: black;">摄食</span>)，<span style="color: black;">倘若</span>漏服，<span style="color: black;">能够</span>补服，下次服药仍<span style="color: black;">根据</span>原间隔时间。<span style="color: black;">倘若</span>服药后<span style="color: black;">出现</span>呕吐，不可补服，下次服药仍<span style="color: black;">根据</span>原间隔时间。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;"><span style="color: black;">举荐</span>剂量：</strong>400mg，每日一次，空腹口服。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">剂量<span style="color: black;">调节</span></strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">倘若</span>因不良反应<span style="color: black;">必须</span><span style="color: black;">减少</span>，按表1进行，当减至最低剂量时仍<span style="color: black;">没</span>法耐受不良反应时，永久停用Pralsetinib。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">表1：</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="//q2.itc.cn/images01/20240514/e5c49ae2f8684c7fbb7454e11ca77c3c.jpeg" style="width: 50%; margin-bottom: 20px;"></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">倘若</span>因不良反应<span style="color: black;">必须</span><span style="color: black;">调节</span>给药<span style="color: black;">方法</span>，按表2进行。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">表2：</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="//q8.itc.cn/images01/20240514/f18d366e12c748cd85b7598cd2089278.jpeg" style="width: 50%; margin-bottom: 20px;"></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">在<span style="color: black;">吃下</span>Pralsetinib普拉替尼<span style="color: black;">时期</span><span style="color: black;">尽可能</span>避免<span style="color: black;">运用</span>强效CYP3A4和 P-gp<span style="color: black;">控制</span>剂，<span style="color: black;">倘若</span>不可避免时，按表3<span style="color: black;">减少</span><span style="color: black;">吃下</span>。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">停用CYP3A4和P-gp<span style="color: black;">控制</span>剂3-5个半衰期(约3-5天)后，恢复Pralsetinib普拉替尼原剂量。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">在<span style="color: black;">吃下</span>Pralsetinib<span style="color: black;">时期</span><span style="color: black;">尽可能</span>避免<span style="color: black;">运用</span>强效CYP3A4诱导剂，<span style="color: black;">倘若</span>不可避免时，联用后第7天<span style="color: black;">起始</span>，Pralsetinib的剂量加倍。停用CYP3A4诱导剂14天后，恢复Pralsetinib原剂量。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">病人</span>轻度肝损害(总胆红素≤正常值上限和AST>正常值上限，或正常值上限<总胆红素<1.5倍正常值上限)时，<span style="color: black;">没</span>需<span style="color: black;">调节</span>剂量。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">副<span style="color: black;">功效</span>：</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">1.结膜炎、干眼症(多见):表现为眼部红肿、干燥等。<span style="color: black;">大夫</span>可能给您开具眼药水等缓解症状。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">⒉流鼻血(多见):如<span style="color: black;">显现</span>流鼻血，请即坐下，头部稍向前倾，按住<span style="color: black;">流血</span><span style="color: black;">一边</span>的鼻孔。如20分钟还未止血，请前往医院就诊。止血后12小时内不要擦鼻子。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">3.口炎(多见)∶<span style="color: black;">运用</span>软毛牙刷。如牙龈肿痛严重，可用漱口水代替刷牙，避免<span style="color: black;">摄食</span>刺激性<span style="color: black;">食品</span>。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">4.间质性肺病(少见):如<span style="color: black;">显现</span>气短、<span style="color: black;">呼气</span>困难等症状请立即<span style="color: black;">通知</span><span style="color: black;">大夫</span>。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">5.食欲<span style="color: black;">衰退</span>、恶心、呕吐(多见)︰<span style="color: black;">尽可能</span><span style="color: black;">选取</span>容易消化、清淡的<span style="color: black;">食品</span>，少吃多餐，<span style="color: black;">弥补</span>水分。如呕吐严重，请<span style="color: black;">通知</span><span style="color: black;">大夫</span>为您开具止呕药。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">6.肝功能<span style="color: black;">反常</span>(多见):表现为转氨酶、胆红素<span style="color: black;">上升</span>。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">7.肾功能<span style="color: black;">反常</span>(多见):表现为血肌酐、尿素氮<span style="color: black;">升高</span>。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">8.腹泻(多见):少吃多餐,<span style="color: black;">弥补</span>水分，避免食用通便和含<span style="color: black;">海量</span>纤维的<span style="color: black;">食品</span>。如腹泻严重，请<span style="color: black;">通知</span><span style="color: black;">大夫</span>为您开具止泻药。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">9. 皮肤反应(多见):<span style="color: black;">包含</span>皮疹、皮肤瘙痒、指甲变色或质地改变等,治疗结束后会<span style="color: black;">逐步</span>缓解。<span style="color: black;">大夫</span><span style="color: black;">亦</span>可能给您开具抗过敏<span style="color: black;">药品</span>缓解症状。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;"><span style="color: black;">重视</span>事项：</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">间质性肺病(ILD)/肺炎：</strong><span style="color: black;">显现</span>1级或2级反应停止用药直到分解，<span style="color: black;">而后</span>以低剂量恢复用药。因复发性ILD/肺炎而永久停药。3级或4级反应永久停止。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">高血压：</strong>没<span style="color: black;">掌控</span>住高血压的<span style="color: black;">病人</span>不要<span style="color: black;">运用</span>GAVRETO。在<span style="color: black;">起始</span>GAVRETO之前优化血压。1周后监测血压，此后<span style="color: black;">最少</span>每月监测一次，并<span style="color: black;">按照</span>临床指示。<span style="color: black;">按照</span>严重程度，停用、减少剂量或永久停用GAVRETO。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">肝毒性：</strong>在<span style="color: black;">起始</span><span style="color: black;">运用</span>GAVRETO前，在前3个月每2周监测一次ALT和AST，此后每月监测一次，并<span style="color: black;">按照</span>临床指示进行监测。<span style="color: black;">按照</span>严重程度，停用、减少剂量或永久停用GAVRETO。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;"><span style="color: black;">流血</span>事件：</strong>对严重或危及生命的<span style="color: black;">流血</span><span style="color: black;">病人</span>，永久停止GAVRETO。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">伤口愈合受损的<span style="color: black;">危害</span>：</strong>择期手术前<span style="color: black;">最少</span>5天不要<span style="color: black;">运用</span>GAVRETO。在大手术后<span style="color: black;">最少</span>2周内，在伤口愈合之前，不要用药。伤口愈合并发症缓解后恢复<span style="color: black;">运用</span>GAVRETO的安全性尚未确定。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">胚胎-胎儿毒性：</strong>可对胎儿<span style="color: black;">导致</span><span style="color: black;">损伤</span>。女性生殖潜能对胎儿<span style="color: black;">拥有</span>潜在<span style="color: black;">危害</span>，<span style="color: black;">意见</span><span style="color: black;">运用</span>有效的非激素避孕<span style="color: black;">办法</span>。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">（素材<span style="color: black;">源自</span>官方<span style="color: black;">媒介</span>/网络<span style="color: black;">资讯</span>）</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">如需<span style="color: black;">查找</span><span style="color: black;">更加多</span>信息，请咨询公众号<strong style="color: blue;">瘤子快滚</strong>、<strong style="color: blue;">识药查真伪</strong>小程序、<strong style="color: blue;">掌上药店app</strong>的客服.<a style="color: black;"><span style="color: black;">返回首页，查看<span style="color: black;">更加多</span></span></a></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">外链论坛：http://www.fok120.com/</p>
我完全同意你的看法，期待我们能深入探讨这个问题。 你的见解真是独到，让我受益良多。
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