普纳替尼片Ponatinib(Iclusig 45mg Tablets)

产地国家:美国

处方药:是

所属类别:45毫克/片 30片/瓶

包装规格:45毫克/片 30片/瓶

计价单位:瓶

生产厂家英文名:Ariad Pharmaceuticals

原产地英文商品名:Iclusig 45mg/tablets 30tablets/bottle

原产地英文药品名:ponatinib

中文参考商品译名:Iclusig 45毫克/片 30片/瓶

中文参考药品译名:普纳替尼

简介:

近日,美国食品药品监督管理局(FDA)批准Iclusig(ponatinib)治疗有慢性粒性白血病(CML)和Philadelphia染色体阳性急性淋巴母细胞白血病(Ph+ALL),两种罕见血和骨髓疾病的成年。Iclusig阻断促进癌细胞发展某些蛋白。药物每天服用1次治疗有CML和Ph+ ALL的慢性,加速,和母细胞相患者其白血病是对一类被称为酪氨酸激酶抑制剂(TKIs)耐药或不能耐受。Iclusig靶向CML细胞有一种特殊突变,被称为T315I,它使这些细胞对当前批准的TKIs耐药。FDA的药物评价和研究中心血液和肿瘤产品室主任Richard Pazdur,M.D.说:“Iclusig的批准是重要的因为对其他药物不反应的CML患者提供治疗选择,尤其是有T315I 突变很少治疗选择的患者”“Iclusig 是今年底被批准治疗CML的第三个药物和治疗ALL的第二个药物,证实FDA承诺为罕见疾病患者批准安全和有效药物。”批准日期:2012年12月14日 公司:ARIAD Pharmaceuticals, IncICLUSIG(普纳替尼 ponatinib)片 供口服使用美国最初批准:2012年警告:动脉闭塞,静脉血栓栓塞,心力衰竭和肝中毒看到完整的黑框警告完整处方信息。动脉闭塞发生在Iclusig治疗的患者,包括致死性心肌梗死,中风,脑,严重的周围血管疾病的大动脉血管的狭窄,以及需要紧急血运重建程序的至少35%。病人有无心血管危险因素包括患者小于50岁,经历了这些事件,中断或立即停止Iclusig为动脉闭塞。一个利益与风险的考虑应该引​​导一个决定重启Iclusig。静脉血栓栓塞发生在Iclusig治疗的患者的6%。监测血栓栓塞的证据。考虑谁出现严重的静脉血栓栓塞症患者Iclusig的剂量调整或停药。心脏衰竭,包括死亡,发生在Iclusig治疗的患者的9%。监测心脏功能,中断或停止Iclusig新的或恶化的心脏衰竭。肝损伤,肝功能衰竭和死亡都发生在Iclusig治疗的患者。监测肝功能。中断Iclusig若肝之嫌。最近的重大变化BOXED警告:11/2016适应症和用法:11/2016警告和注意事项:11/2016

作用机制:Ponatinib抑制ABL和T315I突变体ABL的体外酪氨酸激酶活性,IC50浓度分别为0.4和2.0 nM.Ponatinib抑制其他激酶的体外活性,IC50浓度在0.1和20 nM之间,包括 VEGFR,PDGFR,FGFR,EPH受体和SRC激酶家族成员,以及KIT,RET,TIE 2和FLT 3.Ponatinib抑制表达天然或突变BCR-ABL的细胞的体外活力,包括T315 I.在小鼠中,治疗与对照相比,使用普纳替尼减少了表达天然或T315I突变体BCR-ABL的肿瘤的大小。

适应症:Iclusive是一种激酶抑制剂,适用于成年患者的慢性期,加速期,或急变期慢性粒细胞白血病(CML)或性Ph+ALL为谁没有其它酪氨酸激酶抑制剂(TKI)治疗被指示的处理。成年患者T315I阳性的慢性粒细胞白血病(慢性期,加速期或急变期)或T315I阳性费城染色体阳性急性淋巴细胞白血病(PH+ALL)的治疗。使用限制:未指明Iclusive,不建议用于治疗新诊断的慢性期CML患者。

剂量用量:每日口服45毫克,含或不含食物肝功能损害:每日口服30毫克修改或中断剂量用于血液学和非血液学毒性剂量形式和强度片剂:15mg,30mg和45mg

禁忌症:无

警告和注意事项

高血压:监测血压高和管理作为临床指征.Pancreatitis:监测血清脂肪酶月,中断或终止Iclusig。

神经病:监测外周和颅神经病的症状。

眼部毒性:在基线进行全面的眼科检查,并在治疗期间定期进行。

出血:中断Iclusig治疗严重或严重的出血。

液体潴留:监测患者体液潴留;中断,减少或停止Iclusig。

心律失常:监测心律失常的症状。

骨髓抑制:血小板减少,中性粒细胞减少和贫血可能需要剂量中断或减少监控全血细胞计数,每2周3个月,然后每月根据临床表现中断Iclusig为ANC <1000个/mm3或血小板<50,000/立方毫米。

肿瘤溶解综合征:确保有足够的水合作用和之前开始治疗与Iclusig正确尿酸水平升高。

可逆性后部白质脑病综合征(RPLS):中断Iclusig和恢复只有一次的事件被解决处理,如果继续治疗胜过RPLS的风险的好处。

受损伤口愈合和胃肠道穿孔:暂时中断发生重大外科手术的患者治疗。

胚胎 – 胎儿毒性:能引起的潜在风险胎儿生殖潜力的胎儿造成伤害的女性提供咨询,并使用有效的避孕措施。

不良反应:最常见的非血液学不良反应(≥20%)为腹痛,皮疹,便秘,头痛,皮肤干燥,疲劳,高血压,发热,关节痛,恶心,腹泻,脂肪酶增加,呕吐,肌痛和疼痛在末端。

药物相互作用

强CYP3A抑制剂:避免同时使用,或减少剂量Iclusig如果不能避免联合给药。

强CYP 3 A诱导剂:避免同时使用。

用于特殊人群:哺乳期,建议女性不要母乳喂养。

储存:15°〜30℃(59°〜86°F)[见USP控制室温]远离儿童。

英文版说明书:

Iclusig(Ponatinib Tablets)IMPORTANT SAFETY INFORMATION, INCLUDING THE BOXED WARNINGWARNING: VASCULAR OCCLUSION, HEART FAILURE, and HEPATOTOXICITYSee full prescribing information for complete boxed warning• Vascular Occlusion: Arterial and venous thrombosis and occlusions have occurred in at least 27% of Iclusig treated patients, including fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and the need for urgent revascularization procedures. Patients with and without cardiovascular risk factors, including patients less than 50 years old, experienced these events. Monitor for evidence of thromboembolism and vascular occlusion.Interrupt or stop Iclusig immediately for vascular occlusion. A benefit risk consideration should guide a decision to restart Iclusig therapy.• Heart Failure, including fatalities, occurred in 8% of Iclusig-treated patients. Monitor cardiac function. Interrupt or stop Iclusig for new or worsening heart failure.• Hepatotoxicity, liver failure and death have occurred in Iclusig-treated patients. Monitor hepatic function. Interrupt Iclusig if hepatotoxicity is suspected.Vascular Occlusion: Arterial and venous thrombosis and occlusions, including fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and the need for urgent revascularization procedures have occurred in at least 27% of Iclusig-treated patients from the phase 1 and phase 2 trials. Iclusig can also cause recurrent or multi-site vascular occlusion. Overall, 20% of Iclusig-treated patients experienced an arterial occlusion and thrombosis event of any grade. Fatal and life-threatening vascular occlusion has occurred within 2 weeks of starting Iclusig treatment and in patients treated with average daily dose intensities as low as 15 mg per day.The median time to onset of the first vascular occlusion event was 5 months.Patients with and without cardiovascular risk factors have experienced vascular occlusion although these events were more frequent with increasing age and in patients with prior history of ischemia, hypertension, diabetes, or hyperlipidemia. Interrupt or stop Iclusig immediately in patients who develop vascular occlusion events.Heart Failure: Fatal and serious heart failure or left ventricular dysfunction occurred in 5% of Iclusig-treated patients (22/449).Eight percent of patients (35/449) experienced any grade of heart failure or left ventricular dysfunction. Monitor patients for signs or symptoms consistent with heart failure and treat as clinically indicated, including interruption of Iclusig. Consider discontinuation of Iclusig in patients who develop serious heart failure.Hepatotoxicity: Iclusig can cause hepatotoxicity, including liver failure and death. Fulminant hepatic failure leading to death occurred in an Iclusig-treated patient within one week of starting Iclusig. Two additional fatal cases of acute liver failure also occurred. The fatal cases occurred in patients with blast phase CML (BP-CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Severe hepatotoxicity occurred in all disease cohorts. Iclusig treatment may result in elevation in ALT, AST, or both.Monitor liver function tests at baseline, then at least monthly or as clinically indicated. Interrupt, reduce or discontinue Iclusig as clinically indicated.Hypertension: Treatment-emergent hypertension (defined as systolic BP≥140 mm Hg or diastolic BP≥90 mm Hg on at least one occasion) occurred in 67% of patients (300/449). Eight patients treated with Iclusig (2%) experienced treatment-emergent symptomatic hypertension as a serious adverse reaction, including one patient (<1%) with hypertensive crisis. Patients may require urgent clinical intervention for hypertension associated with confusion, headache, chest pain, or shortness of breath. In 131 patients with Stage 1 hypertension at baseline, 61% (80/131) developed Stage 2 hypertension.Monitor and manage blood pressure elevations during Iclusig use and treat hypertension to normalize blood pressure. Interrupt, dose reduce, or stop Iclusig if hypertension is not medically controlled. In the event of significant worsening, labile or treatment-resistant hypertension, interrupt treatment and consider eva luating for renal artery stenosis.Pancreatitis: Clinical pancreatitis occurred in 6% (28/449) of patients (5% Grade 3) treated with Iclusig. Pancreatitis resulted in discontinuation or treatment interruption in 6% of patients (25/449). The incidence of treatment-emergent lipase elevation was 41%. Check serum lipase every 2 weeks for the first 2 months and then monthly thereafter or as clinically indicated. Consider additional serum lipase monitoring in patients with a history of pancreatitis or alcohol abuse. Dose interruption or reduction may be required.In cases where lipase elevations are accompanied by abdominal symptoms, interrupt treatment with Iclusig and eva luate patients for pancreatitis. Do not consider restarting Iclusig until patients have complete resolution of symptoms and lipase levels are less than 1.5 x ULN.Neuropathy: Peripheral and cranial neuropathy have occurred in Iclusig-treated patients. Overall, 13% (59/449) of Iclusig-treated patients experienced a peripheral neuropathy event of any grade (2%, grade 3/4). In clinical trials, the most common peripheral neuropathies reported were peripheral neuropathy (4%, 18/449), paresthesia (4%, 17/449), hypoesthesia (2%, 11/449), and hyperesthesia (1%, 5/449). Cranial neuropathy developed in 1% (6/449) of Iclusig-treated patients (<1% grade 3/4).Of the patients who developed neuropathy, 31% (20/65) developed neuropathy during the first month of treatment. Monitor patients for symptoms of neuropathy, such as hypoesthesia, hyperesthesia, paresthesia, discomfort, a burning sensation, neuropathic pain or weakness. Consider interrupting Iclusig and eva luate if neuropathy is suspected.Ocular Toxicity: Serious ocular toxicities leading to blindness or blurred vision have occurred in Iclusig-treated patients. Retinal toxicities including macular edema, retinal vein occlusion, and retinal hemorrhage occurred in 3% of Iclusig-treated patients.Conjunctival or corneal irritation, dry eye, or eye pain occurred in 13% of patients. Visual blurring occurred in 6% of the patients. Other ocular toxicities include cataracts, glaucoma, iritis, iridocyclitis, and ulcerative keratitis. Conduct comprehensive eye exams at baseline and periodically during treatment.Hemorrhage: Serious bleeding events, including fatalities, occurred in 5% (22/449) of patients treated with Iclusig. Hemorrhagic events occurred in 24% of patients. The incidence of serious bleeding events was higher in patients with accelerated phase CML (AP-CML), BP-CML, and Ph+ ALL.Most hemorrhagic events, but not all occurred in patients with grade 4 thrombocytopenia. Interrupt Iclusig for serious or severe hemorrhage and eva luate.Fluid Retention: Serious fluid retention events occurred in 3% (13/449) of patients treated with Iclusig. One instance of brain edema was fatal. In total, fluid retention occurred in 23% of the patients.The most common fluid retention events were peripheral edema (16%), pleural effusion (7%), and pericardial effusion (3%). Monitor patients for fluid retention and manage patients as clinically indicated. Interrupt, reduce, or discontinue Iclusig as clinically indicated. Cardiac Arrhythmias: Symptomatic bradyarrhythmias that led to a requirement for pacemaker implantation occurred in 1% (3/449) of Iclusig-treated patients. Advise patients to report signs and symptoms suggestive of slow heart rate (fainting, dizziness, or chest pain). Supraventricular tachyarrhythmias occurred in 5% (25/449) of Iclusig-treated patients.Atrial fibrillation was the most common supraventricular tachyarrhythmia and occurred in 20 patients. For 13 patients, the event led to hospitalization. Advise patients to report signs and symptoms of rapid heart rate (palpitations, dizziness). Interrupt Iclusig and eva luate.Myelosuppression: Severe (grade 3 or 4) myelosuppression occurred in 48% (215/449) of patients treated with Iclusig.The incidence of these events was greater in patients with AP-CML, BP-CML and Ph+ ALL than in patients with CP-CML. Obtain complete blood counts every 2 weeks for the first 3 months and then monthly or as clinically indicated, and adjust the dose as recommended.Tumor Lysis Syndrome: Two patients (<1%) with advanced disease (AP-CML, BP-CML, or Ph+ ALL) treated with Iclusig developed serious tumor lysis syndrome. Hyperuricemia occurred in 7% (30/449) of patients overall; the majority had CP-CML (19 patients). Due to the potential for tumor lysis syndrome in patients with advanced disease, ensure adequate hydration and treat high uric acid levels prior to initiating therapy with Iclusig.Compromised Wound Healing and Gastrointestinal Perforation: Since Iclusig may compromise wound healing, interrupt Iclusig for at least 1 week prior to major surgery. Serious gastrointestinal perforation (fistula) occurred in one patient 38 days post-cholecystectomy.Embryo-Fetal Toxicity: Iclusig can cause fetal harm. If Iclusig is used during pregnancy, or if the patient becomes pregnant while taking Iclusig, the patient should be apprised of the potential hazard to the fetus. Advise women to avoid pregnancy while taking Iclusig. Most common non-hematologic adverse reactions: (≥20%) were hypertension, rash, abdominal pain, fatigue, headache, dry skin, constipation, arthralgia, nausea, and pyrexia. Hematologic adverse reactions included thrombocytopenia, anemia, neutropenia, lymphopenia, and leukopenia.

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