鲁帕沙布片Rubraca Tablets 250mg(rucaparib)

药店国别:

产地国家:美国

处方药:

所属类别: 250毫克/片 60片/瓶

包装规格: 250毫克/片 60片/瓶

计价单位:瓶

生产厂家中文参考译名:

生产厂家英文名:Clovis Oncology,Inc

原产地英文商品名:RUBRACA 250mg/Tablets 60Tablets/bottles

原产地英文药品名:rucaparib

中文参考商品译名:RUBRACA 250毫克/片 60片/瓶

中文参考药品译名:鲁帕沙布

曾用名:

简介:近日,美国FDA加速批准Rubraca(rucaparib)用于治疗患有某种类型卵巢癌的妇女,Rubraca被批准用于肿瘤携带一种特定基因突变(有害的 BRCA),且已使用两种或多种化疗药物治疗过的晚期卵巢癌女性,该特定基因突变可由一种FDA批准的伴随诊断检测予以确定。批准日期:2016年12月19日 公司:Clovis Oncology, Inc.RUBRACA(鲁帕沙布[rucaparib])片剂,用于口服美国最初批准

作用机制:

Rucaparib是聚(ADP-核糖)聚合酶(PARP)酶的抑制剂,包括PARP-1,PARP-2和PARP-3,它们在DNA修复中起作用。体外研究表明,rucaparib诱导的细胞毒性可能涉及抑制PARP酶活性和增加PARP-DNA复合物的形成,导致DNA损伤,细胞凋亡和癌细胞死亡。 在具有BRCA1/2和其他DNA修复基因缺陷的肿瘤细胞系中观察到rucaparib诱导的细胞毒性和抗肿瘤活性增加。Rucaparib已被证明可降低人类癌症的小鼠异种移植模型中的肿瘤生长,伴有或不伴有BRCA缺陷。

适应症和用法:

RUBRACA是一种聚(ADP-核糖)聚合酶(PARP)抑制剂,表明:•用于复发上皮性卵巢癌,输卵管癌或原发性腹膜癌的成人患者的维持治疗,这些患者对铂类化疗有完全或部分反应。•用于治疗患有有害BRCA突变(种系和/或体细胞)相关的上皮卵巢,输卵管或原发性腹膜癌的成年患者,这些患者已接受过两次或更多次治疗。根据FDA批准的RUBRACA伴随诊断选择患者进行治疗。

剂量和给药:

•推荐剂量为600毫克,每日口服两次,含或不含食物。

•继续治疗直至疾病进展或不可接受的毒性。

•对于不良反应,考虑中断治疗或减少剂量。

剂量形式和强度片剂:

200mg,250mg和300mg

禁忌症:

没有。

警告和注意事项:

•骨髓增生异常综合征/急性髓细胞白血病(MDS/AML):暴露于RUBRACA的患者发生MDS/AML,有些病例是致命的。在基线和之后监测患者的血液毒性。如果确认MDS/AML,则停止。

•胚胎-胎儿毒性:RUBRACA可导致胎儿伤害。告知女性对胎儿潜在风险的生殖潜力并使用有效的感染。

不良反应:

•最常见的不良反应(≥20%)为恶心,乏力(包括呕吐),呕吐,贫血,味觉异常,AST/ALT升高,便秘,食欲减退,腹泻,血小板减少,中性粒细胞减少,口腔炎,鼻咽炎/ URI,皮疹,腹痛/膨胀和呼吸困难。•最常见的实验室异常(≥25%)是肌酐增加,ALT增加,AST增加,碱性磷酸酶增加,血红蛋白减少,胆固醇增加,血小板减少,白细胞减少,淋巴细胞减少和嗜中性粒细胞减少。

药物相互作用:

•CYP1A2,CYP3A,CYP2C9和CYP2C19底物:如果用于临床指示,则调整剂量。

用于特定人群:

•哺乳期:建议女性不要母乳喂养。

包装提供/存储和处理:

提供Rubraca有200mg,250mg和300mg片剂。200毫克片剂:•蓝色,圆形和凹陷,一侧带“C2”•以60片装(每年一次)装瓶(NDC:69660-201-91)250毫克片剂:•白色,钻石,并在一侧用“C25”压印•以60片装(每年一次)装瓶(NDC:69660-202-91)300毫克片剂:•黄色,椭圆形,并在一侧用“C3”压印•以60片装(65C):NDC:69660-203-91存储储存在20°C至25°C(68°F至77°F); 允许偏移15°C至30°C(59°F至86°F)[参见USP Controlled RoomTemperature]。

鲁帕沙布片英文版说明书:

INDICATIONSRubraca is indicated:for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapyfor the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic)-associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies. Select patients for therapy based on an FDA-approved companion diagnostic for RubracaSELECT IMPORTANT SAFETY INFORMATIONMyelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) occur uncommonly in patients treated with Rubraca®(rucaparib) tablets, and are potentially fatal adverse reactions.In approximately 1100 treated patients, MDS/AML occurred in 12 patients (1.1%), including those in long term follow-up. Of these, 5 occurred during treatment or during the 28 day safety follow-up (0.5%). The duration of Rubraca treatment prior to the diagnosis of MDS/AML ranged from 1month to approximately 28 months. The cases were typical of secondary MDS/cancer therapy-related AML; in all cases, patients had received previous platinum-containing regimens and/or other DNA damaging agents. Do not start Rubraca until patients have recovered from hematological toxicity caused by previous chemotherapy(≤Grade 1). Monitor complete blood counts for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment.For prolonged hematological toxicities (> 4 weeks), interrupt Rubraca or reduce dose (see Dosage and Administration in full Prescribing Information) and monitor blood counts weekly until recovery.If the levels have not recovered to Grade 1 or less after 4 weeks or if MDS/AML is suspected, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics.If MDS/AML is confirmed, discontinue Rubraca. Based on its mechanism of action and findings from animal studies, Rubraca can cause fetal harm when administered to a pregnant woman. Apprise pregnant women of the potential risk to a fetus.Advise females of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of Rubraca. Most common adverse reactions in ARIEL3(≥20%; Grade 1-4) were nausea(76%), fatigue/asthenia (73%), abdominal pain/distention (46%), rash (43%), dysgeusia (40%), anemia (39%), AST/ALT elevation(38%), constipation(37%), vomiting(37%), diarrhea(32%), thrombocytopenia (29%), nasopharyngitis/upper respiratory tract infection (29%), stomatitis (28%), decreased appetite (23%), and neutropenia(20%). Most common laboratory abnormalities in ARIEL3(≥ 25%; Grade 1-4) were increase in creatinine (98%), decrease in hemoglobin(88%), increase in cholesterol(84%), increase in alanine aminotransferase (ALT) (73%), increase in aspartate aminotransferase (AST) (61%), decrease in platelets (44%), decrease in leukocytes(44%), decrease in neutrophils(38%), increase in alkaline phosphatase(37%), and decrease in lymphocytes (29%). Most common adverse reactions in Study 10 and ARIEL2(≥20%; Grade 1-4) were nausea(77%), asthenia/fatigue(77%), vomiting(46%), anemia (44%), constipation (40%), dysgeusia (39%), decreased appetite (39%), diarrhea (34%), abdominal pain(32%), dyspnea(21%), and thrombocytopenia (21%). Most common laboratory abnormalities in Study 10 and ARIEL2(≥35%; Grade 1-4) were increase in creatinine(92%), increase in alanine aminotransferase(ALT) (74%), increase in aspartate aminotransferase (AST) (73%), decrease in hemoglobin (67%), decrease in lymphocytes (45%), increase in cholesterol (40%), decrease in platelets(39%), and decrease in absolute neutrophil count (35%). Co-administration of rucaparib can increase the systemic exposure of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, which may increase the risk of toxicities of these drugs.Adjust dosage of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, if clinically indicated.If co-administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing frequency of international normalized ratio (INR) monitoring. Because of the potential for serious adverse reactions in breast-fed children from Rubraca, advise lactating women not to breastfeed during treatment with Rubraca and for 2 weeks after the last dose.https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a6d46c03-bb1d-417b-b8e5-3bffe352fe29

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