依鲁替尼Ibrutinib(Imbruvica Tablets 560mg)

产地国家:美国

处方药:是

所属类别: 560毫克/片 28片/瓶

包装规格: 560毫克/片 28片/瓶

计价单位:瓶

生产厂家英文名:Janssen-Cilag

原产地英文商品名:Imbruvica 560mg/tablets 28capsules/bottles

原产地英文药品名:Ibrutinib

中文参考商品译名:Imbruvica片 560毫克/片 28片/瓶

中文参考药品译名:依鲁替尼

简介:

近日,FDA已批准ibrutinib(Imbruvica 依鲁替尼胶囊)和obinutuzumab(Gazyva)联合用于慢性淋巴细胞白血病(CLL)或小淋巴细胞淋巴瘤(SLL)患者的一线治疗。批准日期:2019年1月28日 公司:Janssen Biotech Inc.IMBRUVICA(依鲁替尼[ibrutinib])胶囊,用于口服IMBRUVICA(依鲁替尼[ibrutinib])片剂,用于口服美国最初批准:2013年最近的重大变化剂量和用法:01/2019警告和注意事项:01/2019

作用机制:依鲁替尼是BTK的小分子抑制剂。依鲁替尼与BTK活性位点中的半胱氨酸残基形成共价键,导致BTK酶活性的抑制。BTK是B细胞抗原受体(BCR)和细胞因子受体途径的信号分子。BTK在通过B细胞表面受体的信号传导中的作用导致B细胞运输,趋化性和粘附所必需的途径的激活。非临床研究表明,依鲁替尼抑制体内恶性B细胞增殖和存活以及体外细胞迁移和底物粘附。

适应症和用法:IMBRUVICA是一种激酶抑制剂,适用于治疗成人患者:至少接受过一次治疗的套细胞淋巴瘤(MCL)。根据总体响应率,该指示获得了加速批准。对该指征的持续批准可能取决于验证试验中的临床益处的验证和描述。慢性淋巴细胞白血病(CLL)/小淋巴细胞淋巴瘤(SLL)。慢性淋巴细胞白血病(CLL)/小淋巴细胞淋巴瘤(SLL),17p缺失。Waldenström的巨球蛋白血症(WM)。边缘区淋巴瘤(MZL)需要全身治疗并且至少接受过一次抗CD20治疗。根据总体响应率,该指示获得了加速批准。对该指征的持续批准可能取决于验证试验中的临床益处的验证和描述。一次或多次全身治疗失败后慢性移植物抗宿主病(cGVHD)。

剂量和给药:MCL和MZL:每天口服560毫克。CLL/SLL,WM和cGVHD:每日口服420毫克。剂量应该用一杯水口服。不要打开,折断或咀嚼胶囊。不要切割,压碎或咀嚼片剂。

剂量形式和强度:胶囊,70毫克和140毫克片剂,140mg,280mg,420mg和560mg

禁忌症:没有

警告和注意事项:(1)出血:对出血监视。(2)感染:监视对发热和感染患者和及时评价。(3)骨髓抑制:每月检查全血细胞计数.(4)肾毒性:监视肾功能和保持水化.(5)第二个原发恶性肿瘤:患者中曾发生其他恶性肿瘤,包括皮肤癌,和其他癌.(6)胚胎-胎儿毒性:可致胎儿危害。忠告妇女对胎儿潜在风险当妊娠时避免服药。

不良反应:最常见不良反应(≥20%)in患者with MCL were血小板减少,腹泻,中性粒细胞减少,贫血,疲乏,肌肉骨骼痛,外周性水肿,上呼吸道感染,恶心,瘀伤,呼吸困难,便秘,皮疹,腹痛,呕吐和食欲减低

药物相互作用:(1)CYP3A抑制剂:如上所述修改IMBRUVICA剂量。(2)CYP3A诱导剂:避免与强CYP3A诱导剂共同给药。

用于特定人群:肝功能损害(基于Child-Pugh标准),避免在严重基线肝功能损害患者中使用IMBRUVICA。对于轻度或中度损伤的患者,减少IMBRUVICA剂量。

包装:胶囊,70mg,140mg;片剂,140mg,280mg,420mg,560mg

储存:室温20°C至25°C(68°F至77°F)的温度下。允许在15°C至30°C(59°F至86°F)之间进行短途旅行。

英文版说明书:

IMBRUVICA ® (ibrutinib) capsules, for oral useIMBRUVICA ® (ibrutinib) tablets, for oral useInitial U.S. Approval: 2013RECENT MAJOR CHANGESIndications and Usage:08/2017Dosage and Administration:02/2018Warnings and Precautions:12/2017Mechanism of ActionIbrutinib is a small-molecule inhibitor of BTK. Ibrutinib forms a covalent bond with a cysteine residue in the BTK active site, leading to inhibition of BTK enzymatic activity. BTK is a signaling molecule of the B-cell antigen receptor (BCR) and cytokine receptor pathways. BTK’s role in signaling through the B-cell surface receptors results in activation of pathways necessary for B-cell trafficking, chemotaxis, and adhesion. Nonclinical studies show that ibrutinib inhibits malignant B-cell proliferation and survival in vivo as well as cell migration and substrate adhesion in vitro.INDICATIONS AND USAGEIMBRUVICA is a kinase inhibitor indicated for the treatment of adult patients with:Mantle cell lymphoma (MCL) who have received at least one prior therapy.Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL).Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion.Waldenström’s macroglobulinemia (WM).Marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy.Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.Chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy.DOSAGE AND ADMINISTRATIONMCL and MZL: 560 mg taken orally once daily.CLL/SLL, WM, and cGVHD: 420 mg taken orally once daily.Dose should be taken orally with a glass of water. Do not open, break, or chew the capsules. Do not cut, crush, or chew the tablets.DOSAGE FORMS AND STRENGTHSCapsules: 70mg and 140mg.Tablets: 140mg, 280mg, 420mg, and 560mg.CONTRAINDICATIONSNoneWARNINGS AND PRECAUTIONSHemorrhage: Monitor for bleeding and manage.Infections: Monitor patients for fever and infections, eva luate promptly, and treat.Cytopenias: Check complete blood counts monthly.Cardiac arrhythmias: Monitor for symptoms of arrhythmias and manage.Hypertension: Monitor blood pressure and treat.Second Primary Malignancies: Other malignancies have occurred in patients, including skin cancers, and other carcinomas.Tumor Lysis Syndrome (TLS): Assess baseline risk and take precautions. Monitor and treat for TLS.Embryo-Fetal Toxicity: Can cause fetal harm. Advise women of the potential risk to a fetus and to avoid pregnancy while taking the drug and for 1 month after cessation of therapy. Advise men to avoid fathering a child during the same time period.ADVERSE REACTIONSThe most common adverse reactions (≥20%) in patients with B-cell malignancies (MCL, CLL/SLL, WM and MZL) were neutropenia, thrombocytopenia, diarrhea, anemia, musculoskeletal pain, rash, nausea, bruising, fatigue, hemorrhage, and pyrexia.The most common adverse reactions (≥20%) in patients with cGVHD were fatigue, bruising, diarrhea, thrombocytopenia, muscle spasms, stomatitis, nausea, hemorrhage, anemia, and pneumonia.To report SUSPECTED ADVERSE REACTIONS, contact Pharmacyclics at 1-877-877-3536 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.DRUG INTERACTIONSCYP3A Inhibitors: Dose adjustments may be recommended.CYP3A Inducers: Avoid coadministration with strong CYP3A inducers.USE IN SPECIFIC POPULATIONSHepatic Impairment (based on Child-Pugh criteria): Avoid use of IMBRUVICA in patients with severe baseline hepatic impairment. In patients with mild or moderate impairment, reduce IMBRUVICA dose.HOW SUPPLIED/STORAGE AND HANDLINGThe 70 mg capsules are supplied as yellow opaque capsules, marked with “ibr 70 mg” in black ink, and are available in white HDPE bottles with a child-resistant closure:28 capsules per bottle: NDC 57962-070-28The 140 mg capsules are supplied as white opaque capsules, marked with “ibr 140 mg” in black ink, and are available in white HDPE bottles with a child-resistant closure:90 capsules per bottle: NDC 57962-140-09120 capsules per bottle: NDC 57962-140-12Store bottles at room temperature 20°C to 25°C (68°F to 77°F). Excursions are permitted between 15°C and 30°C (59°F to 86°F). Retain in original package until dispensing.The IMBRUVICA (ibrutinib) tablets are supplied in 4 strengths in the following packaging configurations:140 mg tablets: Yellow green to green round tablets debossed with “ibr” on one side and “140” on the other side. Carton of one folded blister card containing two 14-count blister strips for a total of 28 tablets: NDC 57962-014-28280 mg tablets: Purple oblong tablets debossed with “ibr” on one side and “280” on the other side. Carton of one folded blister card containing two 14-count blister strips for a total of 28 tablets: NDC 57962-280-28420 mg tablets: Yellow green to green oblong tablets debossed with “ibr” on one side and “420” on the other side. Carton of one folded blister card containing two 14-count blister strips for a total of 28 tablets: NDC 57962-420-28560 mg tablets: Yellow to orange oblong tablets debossed with “ibr” on one side and “560” on the other side. Carton of one folded blister card containing two 14-count blister strips for a total of 28 tablets: NDC 57962-560-28Store tablets in original packaging at room temperature 20°C to 25°C (68°F to 77°F). Excursions are permitted between 15°C and 30°C (59°F to 86°F).

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