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产地国家日本

处方药

所属类别 250毫克/片 100片/盒

包装规格 250毫克/片 100片/盒

计价单位

生产厂家英文名Janssen Pharmaceutical Co., Ltd.

原产地英文商品名ZYTIGA tab (ザイティガ錠)250mg/tab  100tabs/bottle

原产地英文药品名Abiraterone Acetate

中文参考商品译名ZYTIGA片(ザイティガ錠)250毫克/片  100片/盒

中文参考药品译名醋酸阿比特龙

简介:

部份中文醋酸阿比特龙处方资料(仅供参考)

药品分类:前立腺癌

批准上市日期:2014年9月

适应症和用途:醋酸阿比特龙是一种CYP17抑制剂适用于与泼尼松联用为治疗既往接受含多烯紫杉醇[docetaxel]化疗转移去势难治性前列腺癌患者。

用法用量:ZYTIGA 1,000mg口服给予每天1次与泼尼松联用5mg口服给予每天2次。必须空腹服用ZYTIGA。在服用ZYTIGA 剂量前至少2小时和服用ZYTIGA剂量后至少1小时不应消耗食物。(1)对基线中度肝受损(Child-Pugh类别B)患者,减低ZYTIGA开始剂量至250mg每天1次。(2)对治疗期间发生肝毒性患者,不用ZYTIGA直至恢复。可在减低剂量再次治疗。如患者发生严重肝毒性应终止ZYTIGA。

禁忌症:妊娠或可能成为妊娠妇女禁忌用ZYTIGA。

警告和注意事项:(1)盐皮质激素过量:有心血管疾病史患者谨慎使用ZYTIGA。尚未确定在有射血分量LVEF < 50%或NYHA类别III或IV心衰患者中ZYTIGA的安全性。治疗前控制高血压和纠正低钾血症。至少每月1次监查血压,血清钾和液体潴留症状。(2)肾上腺皮质功能不全:监视肾上腺皮质功能不全的症状和征象。应急情况前,期间和后可能适应增加皮质激素剂量。(3)肝毒性:肝酶增加曾导致药物中断,剂量调整和/或终止。监查肝功能和如建议调整,中断或终止ZYTIGA给药。(4)食物影响:必须空腹服用ZYTIGA。当与食物同时服用醋酸阿比特龙[abiraterone acetate]阿比特龙的暴露(曲线下面积)增加达10倍。

不良反应:最常见不良反应(≥ 5%)是关节肿胀或不适,低钾血症,水肿,肌肉不适,热潮红,腹泻,泌尿道感染,咳嗽,高血压,心律失常,尿频,夜尿,消化不良,和上呼吸道感染。

包装规格:250mg/片*100片/盒

英文版说明书:

ZYTIGA® (abiraterone acetate) Plus Prednisone for Asymptomatic or Mildly Symptomatic Chemotherapy-Naïve Patients with Metastatic Castration-Resistant Prostate CancerSecond ZYTIGA Phase 3 Study to be Unblinded, Based on Unanimous Recommendation of Independent Data Monitoring CommitteeRaritan, NJ (March 8, 2012) – Janssen Research & Development, LLC today announced that it has unblinded the Phase 3 study of ZYTIGA® (abiraterone acetate) plus prednisone for the treatment of asymptomatic or mildly symptomatic patients with metastatic castration-resistant prostate cancer (CRPC) who have not received chemotherapy.Study COU-AA-302 is an international, randomized, double-blind, placebo controlled study that included 1,088 patients who were randomized to receive ZYTIGA 1,000 milligrams (mg) administered once daily plus prednisone 5 mg administered twice daily or placebo plus prednisone 5 mg administered twice daily. The co-primary endpoints of the study are radiographic progression-free survival and overall survival.The Independent Data Monitoring Committee (IDMC) unanimously recommended unblinding the study based on a planned interim analysis in which differences in radiographic progression-free survival, overall survival, and secondary endpoints were observed that constitute evidence of clinical benefit as well as continued evidence of favorable safety in patients receiving abiraterone acetate plus prednisone as compared to those receiving placebo plus prednisone. Based on these results, the IDMC also recommended that patients in the placebo arm be offered treatment with ZYTIGA.These results will be presented at an upcoming medical meeting and will also be submitted for publication in a peer-reviewed journal.“The COU-AA-302 study has been a key priority for us as we expand our understanding of the utility of ZYTIGA in metastatic prostate cancer,” said William N. Hait, MD, PhD, Global Head, Janssen R&D. “We’re delighted that these data will soon be added to the growing body of literature about this important medication.”ZYTIGA has not been approved for use in men with metastatic CRPC who have not yet received chemotherapy. The company plans to submit for regulatory approval in the United States and around the world beginning in the second half of 2012.The recommendation to unblind a clinical study at an interim analysis is made by an Independent Data Monitoring Committee based on predetermined criteria, such as meeting certain efficacy endpoints and the risk/benefit profile, as well as ethical considerations. In cases where there is compelling evidence of clinical benefit, the IDMC may also recommend that patients in the placebo arm of the study be crossed over to the active arm.About ZYTIGA“Since its first approval in the U.S. in 2011, ZYTIGA has been approved in 39 additional countries, many thousands of men have received treatment with it, and it is quickly becoming one of the cornerstones of our oncology offerings,” said Hait.ZYTIGA in combination with prednisone was approved by the U.S. Food and Drug Administration (FDA) in April 2011 for the treatment of men with metastatic castration-resistant prostate cancer who have received prior chemotherapy containing docetaxel. The Phase 3 study for this initial ZYTIGA indication was also unblinded at the interim point, in August 2010, based on a statistically significant improvement in overall survival and an acceptable safety profile. A subsequent analysis with more mature data confirmed the survival benefit and safety profile.IndicationZYTIGA® (abiraterone acetate) in combination with prednisone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC) who have received prior chemotherapy containing docetaxel.Important Safety InformationContraindications – ZYTIGA® (abiraterone acetate) may cause fetal harm (Pregnancy Category X) and is contraindicated in women who are or may become pregnant.Hypertension, Hypokalemia and Fluid Retention Due to Mineralocorticoid Excess – Use with caution in patients with a history of cardiovascular disease or with medical conditions that might be compromised by increases in hypertension, hypokalemia, and fluid retention. ZYTIGA® may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition. Safety has not been established in patients with LVEF <50% or New York Heart Association (NYHA) Class III or IV heart failure because these patients were excluded from the randomized clinical trial. Control hypertension and correct hypokalemia before and during treatment. Monitor blood pressure, serum potassium, and symptoms of fluid retention at least monthly.Adrenocortical Insufficiency (AI) – AI has been reported in clinical trials in patients receiving ZYTIGA® in combination with prednisone, after an interruption of daily steroids and/or with concurrent infection or stress. Use caution and monitor for symptoms and signs of AI if prednisone is stopped or withdrawn, if prednisone dose is reduced, or if the patient experiences unusual stress. Symptoms and signs of AI may be masked by adverse reactions associated with mineralocorticoid excess seen in patients treated with ZYTIGA®. Perform appropriate tests, if indicated, to confirm AI. Increased dosages of corticosteroids may be used before, during, and after stressful situations.Hepatotoxicity – Increases in liver enzymes have led to drug interruption, dose modification, and/or discontinuation. Monitor liver function and modify, withhold, or discontinue ZYTIGA® dosing as recommended (see Prescribing Information for more information). Measure serum transaminases [alanine aminotransferase (ALT) and aspartate aminotransferase (AST)] and bilirubin levels prior to starting treatment with ZYTIGA®, every two weeks for the first three months of treatment, and monthly thereafter. Promptly measure serum total bilirubin, AST, and ALT if clinical symptoms or signs suggestive of hepatotoxicity develop. Elevations of AST, ALT, or bilirubin from the patient’s baseline should prompt more frequent monitoring. If at any time AST or ALT rise above five times the upper limit of normal (ULN) or the bilirubin rises above three times the ULN, interrupt ZYTIGA® treatment and closely monitor liver function.Food Effect – ZYTIGA® must be taken on an empty stomach. Exposure of abiraterone increases up to 10-fold when abiraterone acetate is taken with meals. No food should be eaten for at least two hours before the dose of ZYTIGA® is taken and for at least one hour after the dose of ZYTIGA® is taken.Abiraterone Cmax and AUC0-∞(exposure) were increased up to 17- and 10-fold higher, respectively, when a single dose of abiraterone acetate was administered with a meal compared to a fasted state.Adverse Reactions – The most common adverse reactions (≥5%) are joint swelling or discomfort, hypokalemia, edema, muscle discomfort, hot flush, diarrhea, urinary tract infection, cough, hypertension, arrhythmia, urinary frequency, nocturia, dyspepsia, fractures and upper respiratory tract infection.Drug Interactions – ZYTIGA® is an inhibitor of the hepatic drug-metabolizing enzyme CYP2D6. Avoid coadministration with CYP2D6 substrates that have a narrow therapeutic index. If an alternative cannot be used, exercise caution and consider a dose reduction of the CYP2D6 substrate. Additionally, abiraterone is a substrate of CYP3A4 in vitro. Strong inhibitors and inducers of CYP3A4 should be avoided or used with caution.Use in Specific Populations – The safety of ZYTIGA® in patients with baseline severe hepatic impairment has not been studied. These patients should not receive ZYTIGA®.http://www.info.pmda.go.jp/go/pack/4291033F1024_1_03/

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