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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->化疗药物
处方药:处方药
包装规格: 25毫克/胶囊, 28胶囊/盒, 4盒/包
计价单位: Carton
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生产厂家中文参考译名:
诺华制药公司
生产厂家英文名:
Novartis Pharmaceuticals Corporation
该药品相关信息网址1:
https://www.us.rydapt.com
该药品相关信息网址2:
https://en.wikipedia.org/wiki/Midostaurin
原产地英文商品名:
Rydapt 25mg, 112 soft Capsules (28 capsules/pack, 4 packs/Carton)
原产地英文药品名:
midostaurin
中文参考商品译名:
Rydapt 25毫克,112粒软胶囊(28粒/包,4包/纸箱)
中文参考药品译名:
雷德帕斯
原产地国家批准上市年份:
2017/05/04
英文适应病症1:
Acute myeloid leukemia (AML) positive for FLT3 mutation
临床试验期:
完成
中文适应病症参考翻译1:
FLT3突变阳性的急性骨髓性白血病(AML)
药品信息:

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 详细处方信息以本药内容附件PDF文件(201872323225512.PDF)的“原文Priscribing Information”为准
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 部分中文Rydapt处方资料(仅供参考)

Rydapt(midostaurin 中文药名:雷德帕斯胶囊)-Rydapt是第一个靶向治疗与化疗联用治疗有AML患者

    作用机制 Midostaurin是抑制多种受体酪氨酸激酶的小分子。 体外生物化学或细胞测定显示,midostaurin或其主要的人类活性代谢物CGP62221和CGP52421抑制野生型FLT3,FLT3突变型激酶(ITD和TKD),KIT(野生型和D816V突变体),PDGFRα/β,VEGFR2的活性 ,以及丝氨酸/苏氨酸激酶PKC(蛋白激酶C)家族的成员。 中度石蜡表现出抑制FLT3受体信号传导和细胞增殖的能力,并且其在表达ITD和TKD突变体FLT3受体或过表达野生型FLT3和PDGF受体的白血病细胞中诱导凋亡。 Midostaurin还表现出抑制KIT信号,细胞增殖和组胺释放并诱导肥大细胞凋亡的能力。

 使用限制

    适应症和用途

RYDAPT未被指定为用于治疗AML患者的单一药物诱导疗法。 侵袭性系统性肥大细胞增多症(ASM),伴有血液肿瘤的系统性肥大细胞增多症(SM-AHN)或肥大细胞白血病(MCL)。

 RYDAPT是一种激酶抑制剂适用为成年患者和上呼吸道感染的治疗。(6.1)有: ● ASM,SM-AHN,或MCL:最常见不良反应(≥ 20%)为恶心,呕吐,腹泻,水肿,肌肉骨骼痛,腹痛,疲乏,上呼吸道感染,便秘,发热, ● 新诊断急性髓性白血病(AML)是FLT3突变阳性当用一个FDA-批准的测试检测, 标准阿糖胞苷[cytarabine]和柔红霉素[daunorubicin]联用诱导和阿糖胞苷巩固(1.1).

    剂量和给药方法

  AML:50毫克口服每日两次食物。 ASM,SM-AHN和MCL:100毫克口服每日两次食物。

    禁忌证

   对midostaurin或任何赋形剂的超敏反应 警告和注意事项 胚胎 - 胎儿毒性:当对孕妇进行管理时,RYDAPT可能会引起胎儿的伤害。建议胎儿的潜在风险。 肺部毒性:监测间质性肺病或肺炎的症状。停止RYDAPT患有肺部毒性征兆或症状的患者。发生致命案件。

 不良反应

  AML:最常见的不良反应(≥20%)为发热性中性粒细胞减少症,恶心,粘膜炎,呕吐,头痛,瘀点,肌肉骨骼疼痛,鼻出血,器官相关感染,高血糖症和上呼吸道感染。 ASM,SM-AHN或MCL:最常见的不良反应(≥20%)为恶心,呕吐,腹泻,水肿,肌肉骨骼疼痛,腹痛,疲劳,上呼吸道感染,便秘,发热,头痛和呼吸困难。

RYDAPT ®

Generic Name and Formulations: Midostaurin capsule

Company: Novartis Pharmaceuticals Corp
Select therapeutic use: Leukemias, lymphomas, and other hematologic cancers Indications for RYDAPT: Treatment of adults with newly diagnosed FLT3 mutation-positive acute myeloid leukemia (AML) as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction + cytarabine consolidation. Treatment of adults with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL). Limitations Of use: Not for use as single-agent induction therapy for AML. Adult: Swallow whole. Take with food approx. 12hrs apart. Give prophylactic antiemetics prior to initiation. AML: 50mg twice daily on Days 8–21 of each induction cycle with cytarabine and daunorubicin, and on Days 8–21 of each consolidation cycle with high-dose cytarabine. ASM, SM-AHN, MCL: 100mg twice daily until disease progression or unacceptable toxicity. Dose modifications: see full labeling. Children: Not established. Warnings/Precautions: For ASM, SM-AHN, MCL: Monitor for toxicity at least weekly for first 4 weeks, every other week for next 8 weeks, and monthly thereafter. Discontinue if low ANC, platelet count, or hemoglobin persists >21 days. Interrupt dose if Grade 3/4 nausea and/or vomiting despite antiemetics or other Grade 3/4 non-hematological toxicities; resume at reduced dose and increase if tolerated (see full labeling). Both: monitor for signs/symptoms of interstitial lung disease or pneumonitis; discontinue if pulmonary toxicity develops. Embryo-fetal toxicity. Pregnancy; exclude status within 7 days prior to initiation. Females of reproductive potential and males should use effective contraception during and for at least 4 months after last dose. Nursing mothers: not recommended (during and for at least 4 months after last dose). Interactions: Concomitant drugs that prolong QT interval; monitor EKG periodically. Potentiated by strong CYP3A inhibitors (eg, boceprevir, clarithromycin, cobicistat, conivaptan, danoprevir/ritonavir, diltiazem, elvitegravir/ritonavir, grapefruit juice, idelalisib, indinavir/ritonavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, paritaprevir/ritonavir and [ombitasvir and/or dasabuvir], posaconazole, ritonavir, saquinavir/ritonavir, tipranavir/ritonavir, troleandomycin, voriconazole); consider alternatives; if co-administration needed, monitor for increased adverse reactions. Avoid concomitant strong CYP3A inducers (eg, carbamazepine, enzalutamide, mitotane, phenytoin, rifampin, St. John's wort). Pharmacological Class: Kinase inhibitor. Adverse Reactions: AML: Febrile neutropenia, nausea, mucositis, vomiting, headache, petechiae, musculoskeletal pain, epistaxis, device-related infection, hyperglycemia, upper respiratory tract infection. ASM, SM-AHN, MCL: also diarrhea, edema, abdominal pain, fatigue, constipation, pyrexia, dyspnea; pulmonary toxicity.

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 详细处方信息以本药内容附件PDF文件(201872323225512.PDF)的“原文Priscribing Information”为准
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更新日期: 2018-07-24
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