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详细处方信息以本药内容附件PDF文件（201952922194622.pdf）的“原文Priscribing Information”为准
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部分中文Xtandi处方资料（仅供参考）

【英文名称】Xtandi

【适用证】

XTANDI是一种雄激素受体抑制剂，适用于治疗去势抵抗性前列腺癌患者。（1）

【用法用量】

XTANDI 160mg（四个40mg胶囊）每日口服一次。 整个吞服胶囊。 XTANDI可以带或不带食物。（2.1）

接受XTANDI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。（2.3）

【禁忌】

无

【使用注意】

•接受XTANDI治疗的患者中有0.4％发生癫痫发作。 在有诱发因素的患者中，2.2％的患者报告癫痫发作。 在治疗期间发生癫痫发作的患者中永久停用XTANDI。（5.1）

•后部可逆性脑病综合征（PRES）：停用XTANDI。（5.2）

•过敏症：停止使用XTANDI。（5.3）

•缺血性心脏病：优化心血管危险因素的管理。 停止使用XTANDI进行3-4级比赛。（5.4）

•接受XTANDI的患者分别有10％和8％发生跌倒和骨折。 评估患者的骨折和跌倒风险，并根据既定指南治疗骨靶向药物患者。（5.5）

•胚胎 - 胎儿毒性：XTANDI可导致胎儿伤害和怀孕。 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。 （5.6,8.1,8.3）

【INDICATIONS AND USAGE】

XTANDI is an androgen receptor inhibitor indicated for the treatment of patients with castration-resistant prostate cancer. (1)

【CONTRAINDICATIONS】

None. (4)

【WARNINGS AND PRECAUTIONS】

•Seizure occurred in 0.4% of patients receiving XTANDI. In patients with predisposing factors, seizures were reported in 2.2% of patients. Permanently discontinue XTANDI in patients who develop a seizure during treatment.(5.1)

•Posterior reversible encephalopathy syndrome (PRES): Discontinue XTANDI. (5.2)

•Hypersensitivity: Discontinue XTANDI. (5.3)

•Ischemic Heart Disease: Optimize management of cardiovascular risk factors. Discontinue XTANDI for Grade 3-4 events. (5.4)

•Falls and Fractures occurred in 10% and 8% of patients receiving XTANDI, respectively. Evaluate patients for fracture and fall risk, and treat patients with bone-targeted agents according to established guidelines. (5.5)

•Embryo-Fetal Toxicity: XTANDI can cause fetal harm and loss of pregnancy. Advise males with female partners of reproductive potential to use effective contraception. (5.6, 8.1, 8.3)

【DOSAGE AND ADMINISTRATION】

XTANDI 160 mg (four 40 mg capsules) administered orally once daily. Swallow capsules whole. XTANDI can be taken with or without food. (2.1)

Patients receiving XTANDI should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. (2.3)

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详细处方信息以本药内容附件PDF文件（201952922194622.pdf）的“原文Priscribing Information”为准
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