Nivolumab是一种用于治疗多种癌症的免疫治疗单克隆抗体（mAb）。目前关于其在哺乳期的使用证据不足。本文报告了一位39岁的转移性黑色素瘤患者，在哺乳期每四周使用480 mg的nivolumab治疗。在连续34天的观察期内，收集了乳汁样本，其中包括两个nivolumab周期。第一个周期中，第13天测得的nivolumab最高浓度为503 ng/mL。第一个周期（28天）的累积相对婴儿剂量（RID）为9.8%。第33天，即第二个nivolumab周期给药后的五天，测得的nivolumab最高总浓度为519 ng/mL。nivolumab在乳汁中似乎会在两个连续周期中积累，因此预计连续周期的RID会更高。为了进一步得出有关在nivolumab治疗期间母乳喂养安全性的结论，需要更多关于新生儿口服的nivolumab生物利用度、乳汁中nivolumab稳态浓度以及其药效学影响的信息。版权2023年归作者所有。由Elsevier Masson SAS出版。保留所有权利。

Nivolumab is an immunotherapeutic monoclonal antibody (mAb) that is used for the treatment of several types of cancer. The evidence on its use during lactation is lacking. Here, we report on a 39-year-old woman with metastasized melanoma who was treated with 480 mg nivolumab every four weeks during lactation. Breast milk samples were collected over the course of 34 days, including two cycles of nivolumab. The highest measured concentration of nivolumab during the first cycle was 503 ng/mL at day 13. The cumulative relative infant dose (RID) over the first cycle (28 days) was 9.8 %. The highest overall measured nivolumab concentration was 519 ng/mL at day 33, five days after administration of the second nivolumab cycle. Nivolumab seems to accumulate in breast milk over two consecutive cycles, hence the RIDs of consecutive cycles are expected to be higher. To draw further conclusions regarding safety of breastfeeding during nivolumab therapy, more information about the oral bioavailability of nivolumab in newborns, the nivolumab steady-state concentrations in breast milk and its pharmacodynamic effects are needed.Copyright © 2023 The Authors. Published by Elsevier Masson SAS.. All rights reserved.