Understanding Darolutamide (Nubeqa): Uses, Dosing, and Safety Information

什么是达洛鲁胺？

Darolutamide (pronounced [DAR oh LOO ta mide]) is also known by the brand name, Nubeqa. It is an antineoplastic (anticancer) medication known as an androgen receptor inhibitor (sometimes grouped with antiandrogens). It works by blocking the androgen (testosterone) receptor to slow prostate cancer growth.

What Kind of Cancer Therapy Is Nubeqa?

Nubeqa is a type of hormone-targeting therapy (androgen receptor inhibitor). It does not work like traditional cytotoxic 化疗.

Safe Handling Precautions

Because Nubeqa is an anticancer medication, follow safe-handling precautions. Do not crush, break, or open the tablets. If a tablet is damaged, avoid direct contact; caregivers may consider wearing gloves when handling broken tablets and should wash their hands after handling. Follow your clinic/pharmacy’s hazardous drug handling guidance (e.g., USP <800>). If you need help taking the tablet, ask your pharmacist for safe-handling tips.

Nubeqa 如何使用？

Nubeqa is FDA-approved to treat certain types of prostate cancer, including non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic castration-sensitive prostate cancer (mCSPC) in specific settings. When used in conjunction with other treatments, Nubeqa can help slow cancer growth and reduce the risk of spread or progression, depending on the clinical setting. Using this drug, men in certain stages of the disease can remain symptom-free for longer periods of time.

PSA tests are one way your provider may monitor response, along with scans and symptoms when appropriate. Nubeqa is most commonly used in conjunction with a 促性腺激素释放激素 (GnRH) 类似物 to help the body inhibit the production of certain hormones (like testosterone). Your prescriber will tell you whether Nubeqa is being used with androgen deprivation therapy (ADT) alone or as part of a combination regimen. Some of the common GnRH analogs are histrelin (Vantas), triptorelin (Trelstar)、戈舍瑞林（Zoladex）和亮丙瑞林（Lupron Depot）。

可用配方

Nubeqa is only available as tablets and must be administered orally. The tablets are only available in 300 mg strength. The tablets are oval-shaped, white, and marked with “300” on one side and “BAYER” on the other side. Nubeqa is commonly taken twice daily with food. Your provider will determine the exact dosing for your situation.

使用方法

Nubeqa 必须与食物一起服用。服用药丸时，请整粒吞服；请勿打开、掰开、压碎、咀嚼或让药丸在口中溶解。

漏服剂量

如果您不小心漏服了一剂，请在下次服药前尽快服用。请勿为了弥补漏服的剂量而同时服用两剂。

贮存

将药丸存放在室温下阴凉干燥处，并确保瓶子紧闭。

服用 Nubeqa 时应避免什么？

在接受 Nubeqa 治疗期间，您必须遵循一些预防措施。请务必告知您的医生您正在服用的任何药物。 Do not take any drug or medicine (even herbals or over-the-counter medications) without prior consent from your physician or pharmacist, as they may have significant interactions with Nubeqa. Tell your provider about any planned vaccines. Your oncology team can advise what is appropriate based on your overall treatment plan.

怀孕和 Nubeqa

此药不适用于女性。如果男性伴侣可能怀孕，应在治疗期间及最后一次服药后一周内采取有效的避孕措施，因为Nubeqa可能会对胎儿造成损害。

副作用

与任何其他药物一样，服用 Nubeqa 时可能会遇到许多副作用。需要注意以下几点：

• 您可能不会出现以下列出的所有副作用。许多人可能几乎没有副作用。
• 副作用的严重程度可能因人而异，因此不要将您的副作用与其他人的经历进行比较。
• 停止治疗后，大多数副作用都会改善。
• 这些副作用大多数情况下都很容易控制，只需调整 Nubeqa 的剂量或使用其他药物来缓解症状即可。请咨询您的医生或药剂师，了解可用的治疗方案。
• 不要隐瞒任何症状；当您感到任何不适时，请毫不犹豫地告诉您的医生或药剂师。 

笔记：此列表并未涵盖所有副作用。如有任何疑问，请咨询医生。

Nubeqa 的一些最常见的副作用是：  

四肢疼痛

Nubeqa has the potential to cause pain in the extremities (hands and feet). This may feel like aching, soreness, or discomfort in the arms or legs. It is not the same as carpal tunnel syndrome. If you experience bothersome pain in your hands, feet, arms, or legs, you should consult your physician on how to treat this side effect.

疲倦和疲劳

可能会出现极度疲倦和乏力的感觉。这种副作用可能突然出现，有时即使休息也无法缓解。建议进行轻度规律的运动，并保证充足的睡眠。从散步等简单的活动开始，逐渐增加到慢跑、慢跑等。疲劳也可能与贫血、抑郁和焦虑有关。通过参与积极的活动来缓解焦虑和抑郁。疲劳有时可能导致跌倒和/或骨折。如果疲劳症状变得难以控制或严重，请告知您的医生。

尿潴留

尿潴留是指无法完全排空膀胱。其症状可能包括尿频、排尿困难或 尿失禁 （无法控制何时排尿）。服用 Nubeqa 期间，如果您发现任何尿潴留的体征或症状，请立即联系医生。

心脏并发症

There is a risk that Nubeqa may raise blood pressure. This side effect may typically present as a very bad headache or dizziness, passing out, or a change in eyesight. High blood pressure and heart-related events have been reported. Your provider may monitor your blood pressure and heart health, especially if you have a history of heart disease. Get urgent medical help for chest pain, sudden shortness of breath, coughing up blood, one-sided leg swelling, or sudden trouble speaking. Typically, these side effects can be controlled with lifestyle changes or medications to treat high blood pressure. While being treated with Nubeqa, blood pressure should be monitored regularly at each office visit.

Lab Changes and Monitoring

Your provider may check blood tests during treatment. Nubeqa can be associated with lab changes such as increased liver enzymes and decreases in some blood cell counts (including neutrophils). Keep all scheduled lab appointments and contact your care team if you develop signs of infection (fever, chills) or unusual bruising/bleeding.

其他常见的副作用可能包括：

• 皮疹
• 跌倒和骨折
• 腹泻
• 恶心
• 肝酶升高

防范措施

除非得到医生的批准，否则通常不建议将 Nubeqa 用于： 

• 对 Nubeqa 或配方中的任何成分过敏的患者。
• 肝肾功能严重受损的患者。可能需要减少剂量。
• 有高血压风险或心脏病史的患者。应定期监测血压。

常见问题解答

Nubeqa 是化学药剂吗？

Nubeqa is not traditional “chemotherapy” (cytotoxic chemo). It is an androgen receptor inhibitor used to treat certain types of prostate cancer.

服用 Nubeqa 的最佳时间是什么时候？

Nubeqa 必须与食物同服。服用药片时，请整片吞服；请勿打开、掰开、压碎、咀嚼或让其在口中溶解。通常每日服用两次（间隔 12 小时）。

达洛他胺有仿制药吗？

There is currently no generic version of darolutamide. However, generic availability can change over time. Ask your pharmacist whether a generic darolutamide is available.