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醋酸阿比特龙片Abiraterone Acetate(Yonsa 125mg Tablets)

产地国家美国

处方药

所属类别 125毫克/片 120片/瓶

包装规格 125毫克/片 120片/瓶

计价单位

生产厂家英文名Sun Pharmaceutical Industries,Inc

原产地英文商品名Yonsa 125mg/Tablet 120Tablet/Bottles

原产地英文药品名abiraterone acetate

中文参考商品译名Yonsa片 125毫克/片 120片/瓶

中文参考药品译名醋酸阿比特龙

简介:

近日,美国FDA已批准Yonsa(abiraterone acetate,醋酸阿比特龙),联合甲泼尼龙(methylprednisolone)用于转移性去势抵抗性前列腺癌(mCRPC)成人患者的治疗。Yonsa是一种CYP17抑制剂,采用了Churchill Pharma公司的SoluMatrix微粒技术制造工艺,提供了一种微粒化的醋酸阿比特龙片剂,使其在体内能被更有效地吸收。

适应症和用法:YONSA是一种CYP17抑制剂,与甲基强的松龙联合用于治疗转移性去势抵抗性前列腺癌(CRPC)患者。剂量和给药为避免用药错误和过量服用,请注意YONSA片剂可能与其他醋酸阿比特龙产品具有不同的剂量和食物效果。

推荐剂量:YONSA 500毫克(4片125毫克片剂),每日口服给药,联合甲基强的松龙4毫克,每日口服两次。接受YONSA治疗的患者还应同时接受促性腺激素释放激素(GnRH)类似物或应进行双侧睾丸切除术。YONSA片剂可以在有或没有食物的情况下服用。片剂应全部用水吞服。不要压碎或咀嚼片剂。

剂量修改:对于有基线中度肝功能损害的患者(Child-Pugh B级),将YONSA起始剂量减少至每天一次125mg。•对于在治疗期间发生肝毒性的患者,请保持YONSA直至康复。可以以减少的剂量开始再处理。如果患者出现严重的肝毒性,应停用YONSA。

剂量形式和强度:片剂:125mg

禁忌症:怀孕。

警告和注意事项

盐皮质激素过多:密切监测心血管疾病患者。控制高血压,治疗前纠正低钾血症。至少每月监测血压,血清钾和液体潴留症状。

肾上腺皮质功能不全:监测肾上腺皮质功能不全的症状和体征。在压力情况之前,期间和之后可以指示增加皮质类固醇的剂量。

肝毒性:可能是严重致命的。监测肝功能并按照建议修改,中断或停止YONSA给药。

不良反应:最常见的不良反应(≥10%)是疲劳,关节肿胀或不适,水肿,潮热,腹泻,呕吐,咳嗽,高血压,呼吸困难,尿路感染和挫伤。最常见的实验室异常(> 20%)是贫血,碱性磷酸酶升高,高甘油三酯血症,淋巴细胞减少,高胆固醇血症,高血糖,AST升高,低磷血症,ALT升高和低钾血症。

药物相互作用:CYP3A4诱导剂:在YONSA治疗期间避免伴随的强CYP3A4诱导剂。如果必须共同施用强CYP3A4诱导剂,则增加YONSA给药频率。CYP2D6底物:避免YONSA与治疗指数较窄的CYP2D6底物共同给药。如果不能使用替代治疗,请谨慎行事,并考虑同时使用CYP2D6底物减少剂量。

用于特定人群:具有生殖潜力的女性和男性:向具有生殖潜力的女性伴侣的男性提供建议,以使用有效的避孕方法。不要在基线严重肝功能损害患者中使用YONSA(Child-Pugh C级)。

存储:在20度至25度(68度至77度); 允许的偏移范围为15度至30度(59度至86度)

英文版说明书:

YONSA(abiraterone acetate) To Treat Metastatic Castration-Resistant Prostate Cancer In Combination With MethylprednisoloneU.S. Food and Drug Administration (FDA) for YONSA® (abiraterone acetate), a novel formulation in combination with methylprednisolone, for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC).INDICATIONYONSA® (abiraterone acetate) in combination with methylprednisolone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC).Important Administration InstructionsTo avoid substitution errors and overdose, be aware that YONSA® tablets may have different dosing and food effects than other abiraterone acetate products. Patients receiving YONSA® should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy.IMPORTANT SAFETY INFORMATIONCONTRAINDICATIONSYONSA® can cause fetal harm and potential loss of pregnancy.WARNINGS AND PRECAUTIONSHypertension, Hypokalemia, and Fluid Retention Due to Mineralocorticoid Excess: YONSA® may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition. Monitor patients for hypertension, hypokalemia, and fluid retention at least once a month. Control hypertension and correct hypokalemia before and during treatment with YONSA®.Closely monitor patients whose underlying medical conditions might be compromised by increases in blood pressure, hypokalemia or fluid retention, such as those with heart failure, recent myocardial infarction, cardiovascular disease, or ventricular arrhythmia. The safety of YONSA® in patients with left ventricular ejection fraction < 50% or New York Heart Association (NYHA) Class III or IV heart failure (in Study 1) or NYHA Class II to IV heart failure (in Study 2) was not established because these patients were excluded from these randomized clinical trials.Adrenocortical Insufficiency (AI): AI was reported in patients receiving abiraterone acetate in combination with corticosteroid, following an interruption of daily steroids and/or with concurrent infection or stress. Monitor patients for symptoms and signs of AI, particularly if patients are withdrawn from corticosteroids, have corticosteroid dose reductions, or experience unusual stress. Symptoms and signs of AI may be masked by adverse reactions associated with mineralocorticoid excess seen in patients treated with YONSA®. Perform appropriate tests, if indicated, to confirm AI. Increased dosages of corticosteroids may be used before, during, and after stressful situations.

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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