艾代拉里斯薄膜片(Zydelig 100mg filmcoated tablets)

产地国家英国

处方药

所属类别 100毫克/片 60片/瓶

包装规格 100毫克/片 60片/瓶

计价单位

生产厂家英文名Gilead Sciences

原产地英文商品名Zydelig filmcoated tablets 100mg/tab 60tabs/bottle

原产地英文药品名idelalisib

中文参考商品译名Zydelig薄膜包衣片 100毫克/片 60片/瓶

中文参考药品译名艾代拉里斯

简介:

部份中文艾代拉利司处方资料(仅供参考)

商品名称Zydelig

英文名称:Idelalisib

中文药名:艾代拉里斯薄膜片

原研公司:Gilead Sciences, Inc.(吉利德)

剂型规格:片薄膜剂:100mg;150mg

药理作用:Idelalisib是一种在正常和恶性B-细胞内表达的PI3Kδ激酶的抑制剂。Idelalisib诱导凋亡和抑制来自恶性B-细胞细胞株和原代肿瘤细胞增殖。Idelalisib抑制几条细胞信号通路,包括B-细胞受体(BCR)信号和CXCR4和CXCR5信号,这参与B-细胞交易和归巢[trafficking和homing]至淋巴结和骨髓。淋巴瘤细胞用idelalisib治疗导致趋化和黏附的抑制,和减低细胞活力。

适应症:与利妥昔单抗联合治疗复发性慢性淋巴细胞白血病(CLL);用于治疗接受过至少2种系统治疗方案的复发性滤泡B细胞非霍奇金淋巴瘤(FL);用于治疗接受过至少2种系统治疗方案的复发性小淋巴细胞淋巴瘤(SLL)。

用法用量:推荐起始剂量为150mg口服,每天2次。

临床优势:Zydelig(idelalisib)是一种首创的高度选择性、口服有效的磷酸肌醇3-激酶delta(PI3K-delta)抑制剂。一项Ⅲ期临床试验(NCT01732913)显示在危险因素分层的所有亚组中,idelalisib组均显著延长了预估无进展生存期,idelalisib组患者总生存显著改善,并且具有显著更高的淋巴结反应率(93%、4%)。与利妥昔单抗单药治疗相比,艾代拉里斯+利妥昔单抗联合疗法对研究的主要终点疾病无进展生存期具有显著的积极影响,表现出了高度统计学显著功效。对于患有复发性血癌的人来说,它能够显著延长患者的无进展生存期。在一系列临床研究中显示出良好的治疗前景,且安全性及耐受性均较好。

国外上市情况:美国:片剂150mg,100mg;Gilead Sciences, Inc.公司持有;商品名Zydelig。欧盟:片剂150mg,100mg(2014.9.18);Gilead Sciences International Ltd公司持有;商品名ZydeligZydelig (idelalisib) 100mg

英文版说明书:

IMPORTANT SAFETY INFORMATIONWARNING: FATAL AND SERIOUS TOXICITIES: HEPATIC, SEVERE DIARRHEA, COLITIS, PNEUMONITIS, AND INTESTINAL PERFORATIONFatal and/or serious hepatotoxicity occurred in 14% of ZYDELIG-treated patients. Monitor hepatic function prior to and during treatment. Interrupt and then reduce or discontinue ZYDELIG as recommendedFatal and/or serious and severe diarrhea or colitis occurred in 14% of ZYDELIG-treated patients. Monitor for the development of severe diarrhea or colitis. Interrupt and then reduce or discontinue ZYDELIG as recommendedFatal and serious pneumonitis can occur. Monitor for pulmonary symptoms and bilateral interstitial infiltrates. Interrupt or discontinue ZYDELIG as recommendedFatal and serious intestinal perforation can occur in ZYDELIG-treated patients. Discontinue ZYDELIG for intestinal perforationContraindicationsHistory of serious allergic reactions, including anaphylaxis and toxic epidermal necrolysis (TEN)Warnings and PrecautionsHepatotoxicity: Findings were generally observed within the first 12 weeks of treatment and reversed with dose interruption. Upon rechallenge at a lower dose, ALT/AST elevations recurred in 26% of patients. In all patients, monitor ALT/AST every 2 weeks for the first 3 months, every 4 weeks for the next 3 months, and every 1 to 3 months thereafter. If ALT/AST is >3x upper limit of normal (ULN), monitor for liver toxicity weekly. If ALT/AST is >5x ULN, withhold ZYDELIG and monitor ALT/AST and total bilirubin weekly until resolved. Discontinue ZYDELIG for recurrent hepatotoxicity. Avoid concurrent use with other hepatotoxic drugsSevere diarrhea or colitis: Grade 3+ diarrhea can occur at any time and responds poorly to antimotility agents. Avoid concurrent use with other drugs that cause diarrheaPneumonitis: eva luate for pneumonitis in patients presenting with pulmonary symptoms such as cough, dyspnea, hypoxia, interstitial infiltrates on radiologic exam, or oxygen saturation decline by ≥5%Intestinal perforation: Advise patients to promptly report any new or worsening abdominal pain, chills, fever, nausea, or vomitingSevere cutaneous reactions: One case of TEN occurred in a study of ZYDELIG in combination with rituximab and bendamustine. Other severe or life-threatening (grade ≥3) cutaneous reactions have been reported. Monitor patients for the development of severe cutaneous reactions and discontinue ZYDELIG if a reaction occursAnaphylaxis: Serious allergic reactions including anaphylaxis have been reported. Discontinue ZYDELIG permanently and institute appropriate supportive measures if a reaction occursNeutropenia: Treatment-emergent grade 3-4 neutropenia occurred in 31% of ZYDELIG-treated patients in clinical trials. In all patients, monitor blood counts ≥every 2 weeks for the first 3 months. In patients with neutrophil counts <1.0 Gi/L, monitor weekly.Embryo-fetal toxicity: ZYDELIG may cause fetal harm. Women who are or become pregnant while taking ZYDELIG should be apprised of the potential hazard to the fetus. Advise women to avoid pregnancy while taking ZYDELIG and to use effective contraception during and at least 1 month after treatment with ZYDELIGAdverse ReactionsMost common adverse reactions (incidence ≥20%; all grades) in clinical studies, when used alone or in combination with rituximab, were diarrhea, pyrexia, fatigue, nausea, cough, pneumonia, abdominal pain, chills, and rashMost frequent serious adverse reactions (SAR) in clinical studies in combination with rituximab were pneumonia (17%), pyrexia (9%), sepsis (8%), febrile neutropenia (5%), and diarrhea (5%); SAR were reported in 49% of patients and 10% of patients discontinued due to adverse reactions. Most frequent SAR in clinical studies when used alone were pneumonia (15%), diarrhea (11%), and pyrexia (9%); SAR were reported in 50% of patients and 53% of patients discontinued or interrupted therapy due to adverse reactionsMost common lab abnormalities (incidence ≥30%; all grades) in clinical studies were neutropenia, hypertriglyceridemia, hyperglycemia, and ALT/AST elevationsDrug InteractionsCYP3A inducers: Avoid coadministration with strong CYP3A inducersCYP3A inhibitors: When coadministered with strong CYP3A inhibitors, monitor closely for ZYDELIG toxicityCYP3A substrates: Avoid coadministration with CYP3A substratesDosage and AdministrationAdult starting dose: One 150 mg tablet twice daily, swallowed whole with or without food. Continue treatment until disease progression or unacceptable toxicity. The safe dosing regimen for patients who require treatment longer than several months is unknownDose modification: Consult the ZYDELIG full Prescribing Information for dose modification and monitoring recommendations for the following specific toxicities: pneumonitis, ALT/AST elevations, bilirubin elevations, diarrhea, neutropenia, and thrombocytopenia. For other severe or life-threatening toxicities, withhold ZYDELIG until toxicity is resolved and reduce the dose to 100 mg, twice daily, upon resuming treatment. If severe or life-threatening toxicities recur upon rechallenge, ZYDELIG should be permanently discontinuedINDICATIONSZYDELIG is indicated for the treatment ofRelapsed follicular B-cell non-Hodgkin lymphoma (FL) in patients who have received at least two prior systemic therapiesRelapsed chronic lymphocytic leukemia (CLL) in combination with rituximab in patients for whom rituximab alone would be considered appropriate therapy due to other comorbiditiesRelapsed small lymphocytic lymphoma (SLL) in patients who have received at least two prior systemic therapiesThe FL and SLL indications were granted accelerated approval based on overall response rate; improvement in patient survival or disease-related symptoms has not been established.

 

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