支持患者过渡到修订后的培西达替尼给药方案：来自多学科临床和联合健康专业团队的观点,Orphanet Journal of Rare Diseases

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支持患者过渡到修订后的培西达替尼给药方案：来自多学科临床和联合健康专业团队的观点
Orphanet Journal of Rare Diseases ( IF 3.4 ) Pub Date : 2023-10-07 , DOI: 10.1186/s13023-023-02926-9
Colleen McCabe ₁ , Hillary Wright _{2,

3} , Kathleen Polson ₃ , Andrew J Wagner ₃

Affiliation

Pexidartinib 是一种集落刺激因子 1 受体抑制剂，在美国获批用于治疗患有症状性腱鞘巨细胞瘤 (TGCT) 的成年患者，这些患者伴有严重的发病率或功能限制，且无法通过手术改善。由于存在严重且可能致命的肝毒性风险，pexidartinib 只能通过风险评估和缓解策略 (REMS) 计划获得。Pexidartinib药代动力学受膳食脂肪含量影响：与空腹状态相比，与pexidartinib一起食用高脂肪膳食可使pexidartinib吸收增加100%；低脂膳食可增加约 60% 的吸收。Pexidartinib最初被授权空腹服用800毫克/天；因此，如果与食物一起服用相同剂量的pexidartinib，则存在过度暴露和潜在毒性的风险。为了降低肝毒性风险并提高患者依从性，pexidartinib 的给药方案进行了修订，从空腹 800 mg/天（400 mg 每天两次）改为 500 mg/天（250 mg 每天两次），低脂餐（约11-14 克总脂肪）。本报告的目的是让临床和专职医疗专业人员了解修订后的给药方案以及患者遵守低脂膳食的重要性。医疗保健专业人员需要了解从空腹服用佩西达替尼到低脂膳食给药的转变的基本原理，以及膳食成分和时间安排如何影响药代动力学。最后，我们为护理佩西达替尼 TGCT 患者的处方提供者、护士、药剂师和营养师组成的医疗团队提供指导。对于医疗保健提供者来说，提供有关低脂膳食要求的一致信息并帮助患者将培西达替尼纳入其常规膳食计划非常重要。咨询营养师可能对患者有帮助，尤其是那些有复杂饮食需求的患者。我们概述了每位医疗保健专业人员的角色和职责，并概述了为患者提供最佳支持的步骤，包括与修订后的给药方案相关的关键问题和答案。本报告提供了必要的信息，以指导护理 TGCT 患者的多学科团队，并支持他们通过佩西达替尼剂量方案的改变。

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Supporting patients in the transition to the revised pexidartinib dosing regimen: perspectives from the multidisciplinary clinical and allied health professional team

Pexidartinib is a colony-stimulating factor-1 receptor inhibitor approved in the United States for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery. Because of the risk of severe and potentially fatal hepatotoxicity, pexidartinib is only available through a Risk Evaluation and Mitigation Strategy (REMS) program. Pexidartinib pharmacokinetics are influenced by the fat content of meals: compared with the fasted state, consuming a high-fat meal with pexidartinib increases pexidartinib absorption by 100%; a low-fat meal increases absorption by approximately 60%. Pexidartinib was initially authorized to be taken at 800 mg/day on an empty stomach; therefore, if this same dose of pexidartinib is taken with food, there is a risk of overexposure and potential toxicity. To reduce the risk of hepatotoxicity and improve patient compliance, pexidartinib has undergone a revised dosing regimen, from 800 mg/day (400 mg twice daily) fasted to 500 mg/day (250 mg twice daily) with a low-fat meal (approximately 11–14 g of total fat). The objective of this report is to educate clinical and allied health professionals on the revised dosing regimen and the importance of patient compliance with a low-fat meal. Healthcare professionals need to understand the rationale for the switch from pexidartinib dosing on an empty stomach to dosing with a low-fat meal and how meal composition and timing influence pharmacokinetics. Finally, we provide guidance for the healthcare team of prescribing providers, nurses, pharmacists, and dietitians who are caring for patients with TGCT on pexidartinib. It is important for healthcare providers to deliver consistent messaging on the low-fat meal requirement and help patients fit pexidartinib into their regular meal schedules. Consulting a dietitian may be helpful for patients, especially those with complex dietary needs. We provide an overview of the roles and responsibilities of each healthcare professional and outline steps to best support patients, including key questions and answers related to the revised dosing regimen. This report provides the information necessary to guide the multidisciplinary team caring for patients with TGCT and to support them through the pexidartinib dosing regimen change.

更新日期：2023-10-08

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