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鲁帕沙布片Rubraca Tablets 200mg(rucaparib)

药店国别:

产地国家:美国

处方药:

所属类别: 200毫克/片 60片/瓶

包装规格: 200毫克/片 60片/瓶

计价单位:

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 200mg/Tablets 60Tablets/bottles

原产地英文药品名:rucaparib

中文参考商品译名:RUBRACA 200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,美国食品和药物管理局FDA批准Rubraca TM(rucaparib)片剂作为单一疗法用于治疗已经用两种或更多种化学疗法治疗的有害BRCA突变(种系和/或体细胞)相关晚期卵巢癌的患者,基于FDA批准的用于Rubraca的伴随诊断选择用于治疗。批准日期:2016年12月19日 公司:Clovis Oncology, Inc.RUBRACA TM(rucaparib)片剂,用于口服使用初始美国批准:2016年

作用机制:

Rucaparib是聚(ADP-核糖)聚合酶(PARP)酶的抑制剂,包括在DNA修复中发挥作用的PARP-1,PARP-2和PARP-3。体外研究表明,rucaparib诱导的细胞毒性可能涉及PARP酶活性的抑制和PARP-DNA复合物的形成增加,导致DNA损伤,细胞凋亡和细胞死亡。 在具有BRCA1/2和其它DNA修复基因缺陷的肿瘤细胞系中观察到增加的rucaparib诱导的细胞毒性。 已经显示Rucaparib在具有或不具有BRCA缺陷的人癌症的小鼠异种移植模型中降低肿瘤生长。

适应症和用法:

RUBRACA是一种聚(ADP-核糖)聚合酶(PARP)抑制剂,表示为单一疗法用于治疗已经用两种或更多种化学疗法治疗的有害的BRCA突变(种系和/或体细胞)相关晚期卵巢癌的患者。根据FDA批准的RUBRACA的伴随诊断选择治疗的患者。该指示根据客观反应率和反应持续时间在加速批准下批准。这种适应症的持续批准可能取决于在验证性试验中临床获益的验证和描述。

剂量和给药:

推荐剂量为600mg口服每天两次,有或无食物。继续治疗,直到疾病进展或不可接受的毒性。对于不良反应,考虑中断治疗或剂量减少。

剂量形式和强度片剂:

200mg和300mg

禁忌症:

没有。

警告和注意事项:

骨髓增生异常综合征/急性骨髓性白血病(MDS/AML):暴露于RUBRACA的患者中发生MDS/AML,包括一个AML的致命事件。在基线和每月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可引起胎儿伤害。建议女性生殖潜力的潜在风险的胎儿和使用有效的避孕。

不良反应:

最常见的不良反应(≥20%)是恶心,疲劳(包括虚弱),呕吐,贫血,腹痛,dysgeusia,便秘,食欲减退,腹泻,血小板减少症和呼吸困难。最常见的实验室异常(≥35%)是肌酐增加,ALT增加,AST增加,血红蛋白减少,淋巴细胞减少,胆固醇增加,血小板减少和绝对中性粒细胞计数减少。在特定人群中使用哺乳:建议妇女不要母乳喂养。

如何供应/存放和处理:

提供Rubraca是200毫克和300毫克片剂。200 mg片剂:蓝色,圆形,并在一边用“C2”凹陷提供瓶装60片(NDC:69660-201-91)300 mg片剂:黄色,椭圆形,并在一侧用“C3”凹陷提供瓶装60片(NDC:69660-203-91)储存于20°C至25°C(68°F至77°F); 偏移允许为15°C至30°C(59°F至86°F)[参见USP控制室温]。

鲁帕沙布片英文版说明书:

polymerase (PARP) inhibitor, is an antineoplastic agent.Uses for RubracaRucaparib camsylate has the following uses:Rucaparib camsylate is a PARP inhibitor indicated as monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with two or more chemotherapies. Select patients for therapy based on an FDA-approved companion diagnostic for rucaparib camsylate.This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.1Rubraca Dosage and AdministrationGeneralRucaparib camsylate is available in the following dosage form(s) and strength(s):Tablets: 200 mg and 300 mgDosageIt is essential that the manufacturer’s labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:•Recommended dose is 600 mg orally twice daily with or without food.•Continue treatment until disease progression or unacceptable toxicity.•For adverse reactions, consider interruption of treatment or dose reduction.Cautions for RubracaContraindicationsNone.Warnings/PrecautionsMyelodysplastic Syndrome/Acute Myeloid LeukemiaMyelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) was reported in 2 of 377 (0.5%) patients with ovarian cancer treated with rucaparib camsylate. The duration of rucaparib camsylate treatment prior to the diagnosis of MDS/AML was 57 days and 539 days. Both patients received prior treatment with platinum and other DNA damaging agents.In addition, AML was reported in 2 (<1%) patients with ovarian cancer enrolled in a blinded, randomized trial eva luating rucaparib camsylate versus placebo. One case of AML was fatal. The duration of treatment prior to the diagnosis of AML was 107 days and 427 days. Both patients had received prior treatment with platinum and other DNA damaging agents.Monitor complete blood count testing at baseline and monthly thereafter. Do not start rucaparib camsylate until patients have recovered from hematological toxicity caused by previous chemotherapy (≤grade 1). For prolonged hematological toxicities, interrupt rucaparib camsylate and monitor blood counts weekly until recovery. If the levels have not recovered to grade 1 or less after 4 weeks, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. If MDS/AML is confirmed, discontinue rucaparib camsylate.Embryo-fetal ToxicityRucaparib camsylate can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings from animal studies. In an animal reproduction study, administration of rucaparib to pregnant rats during organogenesis resulted in embryo-fetal death at maternal exposure that were 0.04 times the AUC in patients receiving the recommended dose of 600 mg twice daily. 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 rucaparib camsylate.Specific PopulationsPregnancyBased on findings from animal studies and its mechanism of action, rucaparib camsylate can cause fetal harm when administered to pregnant women. There are no available data in pregnant women to inform the drug-associated risk. In an animal reproduction study, administration of rucaparib to pregnant rats during organogenesis resulted in embryo-fetal death at maternal exposure that were 0.04 times the AUC0-24h in patients receiving the recommended dose of 600 mg twice daily. Apprise pregnant women of the potential risk to a fetus.The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.In a dose range-finding embryo-fetal development study, pregnant rats received oral doses of 50, 150, 500, or 1000 mg/kg/day of rucaparib during the period of organogenesis. Post-implantation loss (100% early resorptions) was observed in all animals at doses greater than or equal to 50 mg/kg/day (with maternal systemic exposures approximately 0.04 times the human exposure at the recommended dose based on AUC0-24h).LactationThere is no information regarding the presence of rucaparib in human milk, or on its effects on milk production or the breast-fed infant. Because of the potential for serious adverse reactions in breast-fed infants from rucaparib camsylate, advise lactating women not to breastfeed during treatment with rucaparib camsylate and for 2 weeks after the final dose.Females and Males of Reproductive PotentialPregnancy testing is recommended for females of reproductive potential prior to initiating rucaparib camsylate.Rucaparib camsylate can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment and for 6 months following the final dose of rucaparib camsylate.Pediatric UseThe safety and effectiveness of rucaparib camsylate in pediatric patients have not been established.Geriatric UseOne hundred and sixty (42%) of the 377 ovarian cancer patients in clinical trials of rucaparib camsylate were 65 years of age or older. No overall differences in safety were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out. The effectiveness of rucaparib camsylate in patients with BRCA-mutant ovarian cancer who were 65 years of age or older could not be assessed due to the small number of patients (N=38).Hepatic ImpairmentNo starting dose adjustment is recommended for patients with mild hepatic impairment (total bilirubin less than or equal to upper limit of normal [ULN] and AST greater than ULN, or total bilirubin between 1.0 to 1.5 times ULN and any AST). No recommendation of starting dose adjustment is available for patients with moderate to severe hepatic impairment (total bilirubin greater than 1.5 times ULN) due to a lack of data.Renal ImpairmentNo starting dose adjustment is recommended for patients with mild to moderate renal impairment (creatinine clearance [CLcr] between 30 and 89 mL/min, as estimated by the Cockcroft-Gault method). There is no recommended starting dose for patients with CLcr less than 30 mL/min or patients on dialysis due to a lack of data.Common Adverse Effects•Most common adverse reactions (≥20%) were nausea, fatigue (including asthenia), vomiting, anemia, abdominal pain, dysgeusia, constipation, decreased appetite, diarrhea, thrombocytopenia, and dyspnea.•Most common laboratory abnormalities (≥35%) were increase in creatinine, increase in ALT, increase in AST, decrease in hemoglobin, decrease in lymphocytes, increase in cholesterol, decrease in platelets, and decrease in absolute neutrophil count.Drug InteractionsSpecific DrugsIt is essential that the manufacturer’s labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:Please see product labeling for drug interaction information.ActionsMechanism of ActionRucaparib is an inhibitor of PARP enzymes, including PARP-1, PARP-2, and PARP-3, which play a role in DNA repair. In vitro studies have shown that rucaparib-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complexes resulting in DNA damage, apoptosis, and cell death. Increased rucaparib-induced cytotoxicity was observed in tumor cell lines with deficiencies in BRCA1/2 and other DNA repair genes. Rucaparib has been shown to decrease tumor growth in mouse xenograft models of human cancer with or without deficiencies in BRCA.Advice to PatientsAdvise the patient to read the FDA-approved patient labeling (Patient Information).MDS/AMLAdvise patients to contact their healthcare provider if they experience weakness, feeling tired, fever, weight loss, frequent infections, bruising, bleeding easily, breathlessness, blood in urine or stool, and/or laboratory findings of low blood cell counts, or a need for blood transfusions. These may be signs of hematological toxicity or a more serious uncommon bone marrow problem called ‘myelodysplastic syndrome’ (MDS) or ‘acute myeloid leukemia’ (AML) which have been reported in patients treated with rucaparib camsylate.Embryo-Fetal ToxicityAdvise females to inform their healthcare provider if they are pregnant or become pregnant. Inform female patients of the risk to a fetus and potential loss of the pregnancy.1 Advise females of reproductive potential to use effective contraception during treatment and for 6 months after receiving the last dose of rucaparib camsylate.PhotosensitivityAdvise patients to use appropriate sun protection due to the increased susceptibility to sunburn while taking rucaparib camsylate.1LactationAdvise females not to breastfeed during treatment and for 2 weeks after the last dose of rucaparib camsylate.Dosing InstructionsInstruct patients to take rucaparib camsylate orally twice daily with or without food. Doses should be taken approximately 12 hours apart. Advise patients that if a dose of rucaparib camsylate is missed or if the patient vomits after taking a dose of rucaparib camsylate, patients should not take an extra dose, but take the next dose at the regular time.Additional InformationAHFS First Release. For additional information until a more detailed monograph is developed and published, the manufacturer’s labeling should be consulted. It is essential that the manufacturer’s labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.PreparationsExcipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

用药温馨提示:当您服用此药物时,需定期接受医疗专业人士的检查,以便随时针对其药效、副作用等情况进行监测。本网站所包含的信息旨在为患者提供帮助,不能代替医学建议和治疗。
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