What are the precautions for enzalutamide/enzalutamide?

In clinical studies of enzalutamide/enzalutamide, seizures, posterior reversible encephalopathy syndrome (PRES), hypersensitivity reactions, ischemic heart disease, falls and fractures, embryo-fetal toxicity, etc. warnings and precautions have emerged. Discontinue and resume at reduced dose upon recovery, or permanently discontinue based on severity.

1、癫痫发作：在临床试验中，具有癫痫发作诱发因素的患者通常被排除在外。出现癫痫发作的患者永久停止治疗，所有癫痫发作事件均已解决。 Patients in the study had one or more of the following preexisting factors: use of medications that may lower the seizure threshold, history of traumatic brain injury or head injury, cerebrovascular accident or transient ischemic attack, Alzheimer's disease due to prostate cancer, meningiomas, or leptomeningeal disease, unexplained loss of consciousness within the past 12 months, history of previous seizures, presence of space-occupying brain lesions, history of arteriovenous malformations, or history of brain infection. About 17% of patients have more than one risk factor. Inform patients of the risk of seizures while taking enzalutamide and of the risk of participating in any activity in which sudden loss of consciousness could cause serious harm to themselves or others.在治疗期间出现癫痫发作的患者应永久停用恩杂鲁胺。

2. Posterior reversible encephalopathy syndrome (PRES):PRES is a neurological disorder that can present with rapidly progressive symptoms including seizures, headache, drowsiness, confusion, blindness, and other visual and neurological impairments, with or without hypertension. The diagnosis of PRES needs to be confirmed by brain imaging, preferably magnetic resonance imaging (MRI). Enzalutamide should be discontinued in patients who develop PRES.

3、超敏反应：在八项随机临床试验中观察到恩杂鲁胺出现过敏反应，包括面部水肿、舌头水肿或嘴唇水肿。 Pharyngeal edema has been reported in postmarketing cases.建议出现任何过敏症状的患者暂时停用恩杂鲁胺并立即就医。 Permanently discontinue enzalutamide due to severe allergic reaction.

4、缺血性心脏病：在临床研究的综合数据中，缺血性心脏病的发生率更高。 Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors such as hypertension, diabetes, or dyslipidemia.对于3-4级缺血性心脏病，停用恩杂鲁胺。

5、跌倒和骨折：接受恩杂鲁胺治疗的患者发生跌倒和骨折。 Assess the patient's risk for fractures and falls.根据既定的治疗指南监测和管理有骨折风险的患者，并考虑使用骨靶向药物。研究中未进行常规骨密度评估和骨靶向药物治疗骨质疏松症

6、胚胎-胎儿毒性：恩杂鲁胺女性中的安全性和有效性尚未确定。 Based on animal reproduction studies and mechanism of action, enzalutamide can cause fetal harm and pregnancy failure when administered to pregnant women.建议有女性伴侣的男性在接受恩杂鲁胺治疗期间以及在最后一剂后的3个月内使用有效的避孕方法.