普纳替尼(ponatinib,商品名Iclusig)
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授权形式： |
免费版 |
作者/开发商： |
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| 文件大小： |
62.69 |
解压密码： |
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| 软件语言： |
简体中文 |
更新时间： |
2013-08-01 |
| 版本号： |
1.0 |
软件平台： |
Win2000/WinXP/Win2003 |
| 软件类别： |
国产软件 |
演示地址： |
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| 评分等级： |
★★★★★ |
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| 发布人： |
admin |
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0（今日：0，本周：0，本月：0） |
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无插件 |
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147 |
ICLUSIG Rx
Generic Name and Formulations:
Ponatinib 15mg, 45mg; tabs.
Company:
ARIAD Pharmaceuticals, Inc.
RECENT UPDATES
03/08/13
Monograph added.
Indications for ICLUSIG:
Chronic, accelerated, or blast phase chronic myeloid leukemia (CML) that is resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy. Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) that is resistant or intolerant to prior TKI therapy.
Adult Dose for ICLUSIG:
Swallow whole. ≥18yrs: 45mg once daily. Concomitant strong CYP3A inhibitors: reduce to 30mg once daily. Dose modification for hematologic and non-hematologic toxicity: see full labeling.
Children's Dose for ICLUSIG:
<18yrs: not established.
Pharmacological Class:
Kinase inhibitor.
Warnings/Precautions:
Risk of arterial thrombosis; interrupt and consider discontinuing if occurs. Monitor hepatic function prior to and during therapy; interrupt and then reduce or discontinue therapy for hepatotoxicity. Moderate-to-severe hepatic impairment: not recommended. Monitor for CHF, hypertension, fluid retention, cardiac arrhythmias: treat as clinically indicated. Risk of pancreatitis; check serum lipase every 2 weeks for the first 2 months and then monthly thereafter or as clinically indicated. Interrupt therapy for serious or severe hemorrhage. Obtain CBCs every 2 weeks for the first 3 months, then monthly or as clinically indicated. Tumor lysis syndrome; ensure adequate hydration and treat uric levels prior to therapy. Compromised wound healing (withhold for 1 week prior to major surgery) and GI perforation. Elderly. Pregnancy (Cat. D); avoid. Nursing mothers: not recommended.
Interactions:
Potentiated by strong CYP3A inhibitors (eg, boceprevir, clarithromycin, conivaptan, grapefruit juice, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole); see Adult dose. Avoid concomitant strong CYP3A inducers (eg, carbamazepine, rifampin, phenytoin, St. John’s Wort), or drugs that elevate gastric pH (eg, PPIs, H2 blockers, antacids). Caution with concomitant P-gp and ABCG2 substrates.
Adverse Reactions:
Hypertension, rash, abdominal pain, fatigue, headache, dry skin, constipation, arthralgia, nausea, pyrexia, anemia, thrombocytopenia, neutropenia, leukopenia.
Metabolism:
Hepatic (CYP3A4, 2C8, 2D6, 3A5); 99% protein bound.
Elimination:
Fecal.
Generic Availability:
NO
How Supplied:
Tabs 15mg—60, 180; 45mg—30, 90
欧盟批准Ponatinib用于白血病
近日，欧盟委员会已准予ponatinib 上市许可（Iclusig，Ariad制药），作为孤儿药的ponatinib用于对其他治疗耐药或不耐受的在某些白血病患者。
具体而言，ponatinib可用于慢性期、加速期以及急变期的成人慢性髓性白血病（CML） 患者。这些患者对达沙替尼（SPRYCEL）/尼罗替尼（Tasigna）耐药或不耐受，或经伊马替尼（格列卫）治疗后无适当的临床治疗，或存在T315I突变。
此外，也表明，ponatinib可用于Ph+阳性的急性淋巴细胞白血病（ALL） 患者，这些ALL患者对达沙替尼耐药或不耐受的，或经伊马替尼治疗后无恰当方法，或存在T315I突变。
Ponatinib于2012年12月被FDA批准上市用于上述相似症状。
Ariad制药公司表示欧盟人用药产品委员会加速审批了ponatinib上市。此目的在于加快审批对能有益于公众健康的新药。
[ponatinib对BCR-ABL T315I突变患者有效.gif]
ponatinib对BCR-ABL T315I突变患者有效
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