毒理性
哺乳期使用总结：有限的信息表明，母体阿达木单抗注射在母乳中产生低水平。由于阿达木单抗是一种大蛋白分子，它很可能会在婴儿的胃肠道中被部分破坏，婴儿的吸收可能最小。在一些母乳喂养的婴儿的血清中未检测到阿达木单抗，一些信息表明阿达木单抗不会对哺乳婴儿产生不利影响。大多数专家和专业指南认为在哺乳期间使用阿达木单抗是可以接受的。至少在产后2周恢复治疗可能将传递给婴儿的风险降到最低。
对哺乳婴儿的影响：一名患有克罗恩病的女性在怀孕和哺乳期间每周皮下注射阿达木单抗40毫克（具体情况未说明）。她的婴儿在6个月大时表现出正常的生长和发育。作者报告了一个简短的随访，说明该女性在阿达木单抗治疗期间哺乳她的第二个婴儿，没有不良后果。
另一名患有克罗恩病的女性在怀孕和哺乳期间每2周皮下注射阿达木单抗40毫克（具体情况未说明）。她的婴儿在6个月大时表现出正常的生长和发育。
两名女性在未说明的时间间隔内接受阿达木单抗40毫克皮下注射治疗炎症性肠病的同时哺乳她们的婴儿（具体情况未说明）。她们分别哺乳了至少21周和8周，但总时长未说明。在14.5个月和15个月大时，两个婴儿都没有出现任何不良药物反应、过敏反应或严重感染导致住院的迹象。两个婴儿都按时达到了发育里程碑。
一名孕妇在怀孕的前16周每2周接受阿达木单抗40毫克治疗克罗恩病。她的婴儿在4个月大之前是纯母乳喂养的，在产后第24天重新开始用药。在7个月大时，婴儿健康，生长和发育正常。婴儿没有需要使用抗生素或住院治疗的感染。
一项针对患有慢性关节病的女性的病例对照研究发现，有2名女性在怀孕和哺乳期间接受了阿达木单抗治疗（具体情况未说明）。与对照组相比，在出生后的第一年内，这两名婴儿的生长参数、发育里程碑、疫苗接种和疾病方面没有观察到差异。
一名接受阿达木单抗治疗严重银屑病的女性在两次怀孕后哺乳了两个婴儿。尽管没有报告婴儿出现不良反应，但阿达木单抗的剂量和哺乳的程度没有报告。
在一项多中心研究中，针对怀孕期间患有炎症性肠病的女性（PIANO登记研究），有99名女性在哺乳期间接受了阿达木单抗。在那些在哺乳期间接受阿达木单抗或其他生物制剂的母亲中，婴儿的生长、发育或感染率与那些母亲未接受治疗的婴儿没有差异。另外68名女性接受了生物制剂加硫嘌呤。这一组的婴儿结果相似。
对哺乳和母乳的影响：截至修订日期，没有找到相关的已发布信息。
◉ Summary of Use during Lactation:Limited information indicates that maternal adalimumab injections produce low levels in breastmilk. Because adalimumab is a large protein molecule, it is likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal. Adalimumab was undetectable in the serum of some breastfed infants and some information indicates that adalimumab does not adversely affect the nursing infant. Most experts and professional guidelines consider adalimumab to be acceptable to use during breastfeeding. Waiting for at least 2 weeks postpartum to resume therapy may minimize transfer to the infant.
◉ Effects in Breastfed Infants:One woman with Crohn's disease received adalimumab 40 mg subcutaneously every week during pregnancy and breastfeeding (extent not stated). Her infant demonstrated normal growth and development at 6 months of age. The authors reported a brief follow-up stating that the woman also breastfed her second infant during adalimumab therapy with no adverse consequences.
Another woman with Crohn's disease received adalimumab 40 mg subcutaneously every 2 weeks during pregnancy and breastfeeding (extent not stated). Her infant demonstrated normal growth and development at 6 months of age.
Two women nursed their infants (extent not stated) while receiving adalimumab 40 mg subcutaneously at unstated intervals for inflammatory bowel disease. They breastfed for at least 21 weeks and 8 weeks, respectively, but the total duration was not stated. At 14.5 and 15 months of age, respectively, neither infant had any signs of adverse drug reactions, allergic reactions or severe infections leading to hospitalization. Developmental milestones were reached on time by both infants.
A pregnant woman received adalimumab 40 mg every 2 weeks for Crohn's disease until week 16 of pregnancy. Her infant was exclusively breastfed until 4 months of age and the drug was reinstituted on day 24 postpartum. At 7 months of age, the infant was healthy with normal growth and development. The infant had no infections requiring antibiotics or hospitalization.
A case-control study of women with chronic arthritic conditions found 2 women who received adalimumab during pregnancy and lactation (extent not stated). No differences were observed in the 2 infants' growth parameters, developmental milestones, vaccinations and diseases in the first year of life compared to those not exposed to the drugs with lactation.
A woman receiving adalimumab for severe psoriasis breastfed 2 infants following 2 pregnancies. No adverse effects were reported in the infant, although the dosage of adalimumab and the extent of breastfeeding were not reported.
In a multi-center study of women with inflammatory bowel disease in pregnancy (the PIANO registry), 99 women received adalimumab while breastfeeding their infants. Among those who received adalimumab or another biologic agent while breastfeeding, infant growth, development or infection rate was no different from infants whose mothers received no treatment. An additional 68 women received a biologic agent plus a thiopurine. Infant outcomes were similar in this group.
◉ Effects on Lactation and Breastmilk:Relevant published information was not found as of the revision date.
来源:Drugs and Lactation Database (LactMed)
