醋酸阿比特龙片(Zytiga Tablets 500mg)



所属类别: 500毫克/片 60片/瓶

包装规格: 500毫克/片 60片/瓶


生产厂家英文名:Janssen Pharma

原产地英文商品名:ZYTIGA 500mg/tab 60tabs/bottle


中文参考商品译名:ZYTIGA 500毫克/片 60片/瓶





【英文药名】abiraterone acetate


【原研厂家】Cougar Biotechnology,Inc.

【剂 型】薄膜片

【规 格】250mg/500mg片

【适 应 症】ZYTIGA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】推荐剂量:ZYTIGA 1,000 mg口服给予每天1次与泼尼松联用5 mg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250 mg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】 妊娠或可能成为妊娠妇女禁忌用ZYTIGA。

【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。


【特殊人群中使用】在基线严重肝受损(Child-Pugh类别 C)患者中不要使用ZYTIGA。


INDICATIONZYTIGATM (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 INFORMATIONContraindicationsZYTIGATM may cause fetal harm (Pregnancy Category X) and is contraindicated in women who are or may become pregnant.Warnings and PrecautionsHypertension, Hypokalemia and Fluid Retention Due toMineralocorticoid ExcessMineralocorticoid 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. Safety has not been established in patients with LVEF < 50% or NYHA Class III or IV heart failure. Control hypertension and correct hypokalemia before and during treatment.Monitor blood pressure, serum potassium, and symptoms of fluid retention at least monthly.Adrenocortical InsufficiencyAdrenocortical Insufficiency (AI) has been reported in clinical trials 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 Use caution and monitor for symptoms and signs of AI if prednisone is stopped or withdrawn or if the patient experiences unusual stress. Perform appropriate tests, if indicated, to confirm AI.Increased dosages of corticosteroids may be used before, during and after stressful situations.HepatotoxicityHepatotoxicity – Increases in liver enzymes have led to drug interruption, dose modification and/or discontinuation. Monitor liver function and modify, withhold or discontinue ZYTIGATM dosing as recommended (See Prescribing Information for more information).Food EffectFood Effect – ZYTIGATM 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 ZYTIGATM is taken and for at least one hour after the dose of ZYTIGATM is taken.Adverse ReactionsThe most common adverse reactions (≥ 5%) reported in clinical trials were joint swelling or discomfort, hypokalemia, edema, muscle discomfort, hot flush, diarrhea, urinary tract infection, cough, hypertension, arrhythmia, urinary frequency, nocturia, dyspepsia and upper respiratory tract infection.Drug InteractionsZYTIGATM is an inhibitor of the hepatic drug-metabolizing enzyme CYP2D6. Avoid co-administration 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.附件:20116219242032.PDF

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