Lorlatinib is a brain-penetrant, third-generation tyrosine kinase inhibitor (TKI) indicated for the treatment of anaplastic lymphoma kinase ()-positive metastatic non-small cell lung cancer (NSCLC). In clinical trials, lorlatinib has shown durable efficacy and a manageable safety profile in treatment-naive patients and in those who have experienced progression while receiving first- and/or second-generation ALK TKIs. Lorlatinib has a distinct safety profile from other ALK TKIs, including hyperlipidemia and central nervous system effects. Clinical trial data showed that most adverse events (AEs) can be managed effectively or reversed with dose modifications (such as dose interruptions or reductions) or with concomitant medications without compromising clinical efficacy or quality of life for patients. A pragmatic approach to managing AEs related to lorlatinib is required. We present patient-focused recommendations for the evaluation and management of select AEs associated with lorlatinib developed by clinicians and nurses with extensive lorlatinib expertise in routine clinical practice. The recommendations follow the general framework of “prepare, monitor, manage, reassess” to streamline AE management and assist in practical, actionable, and personalized patient care.

中文翻译：

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劳拉替尼相关不良事件管理实用指南

Lorlatinib 是一种脑渗透性第三代酪氨酸激酶抑制剂 (TKI)，适用于治疗间变性淋巴瘤激酶 () 阳性的转移性非小细胞肺癌 (NSCLC)。在临床试验中，lorlatinib 在初治患者和接受第一代和/或第二代 ALK TKI 治疗期间病情进展的患者中显示出持久的疗效和可控的安全性。 Lorlatinib 与其他 ALK TKI 相比具有独特的安全性，包括高脂血症和中枢神经系统影响。临床试验数据表明，大多数不良事件（AE）可以通过剂量调整（例如剂量中断或减少）或联合用药得到有效管理或逆转，而不会影响患者的临床疗效或生活质量。需要采取务实的方法来管理与劳拉替尼相关的不良事件。我们提出了以患者为中心的建议，用于评估和管理与劳拉替尼相关的特定不良事件，这些建议是由在常规临床实践中具有丰富劳拉替尼专业知识的临床医生和护士开发的。这些建议遵循“准备、监测、管理、重新评估”的总体框架，以简化 AE 管理并协助实际、可操作和个性化的患者护理。