Is Adalimumab safe while breastfeeding?

Effects on the breastfed infant

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.[ 16 ] The authors reported a brief follow-up stating that the woman also breastfed her second infant during adalimumab therapy with no adverse consequences.[ 17 ] 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.[ 18 ] 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.[ 13 ] 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.[ 15 ] 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.[ 19 ] 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 ada

Effects on milk supply

Fifty-seven lactating women, 26 with inflammatory bowel disease (IBD) and 31 without had tumor necrosis factor (TNF) and chemokines (IP-10, MCP-1, and MIP-1 ) measured at 2 to 6 weeks postpartum (early lactation) and again at 11 to 16 weeks (mid-lactation) postpartum. The women with IBD who were receiving either adalimumab (n = 5) or infliximab (n = 4) had lower levels of TNF and interferon gamma-induced protein 10 (IP-10) in their milk in early lactation sampling than women with IBD who were not taking a TNF inhibitor. No differences were found between either IBD group and women without IBD at either time point nor between any of the groups at mid-lactation.[ 11 ] An analysis of the US Food and Drug Administration s FAERS database of 7,022 spontaneous adverse reaction reports of anti-TNF drugs found that they may cause an increased risk of lactation insufficiency and disorders. Drugs that were studied included adalimumab, infliximab, golimumab, certolizumab, and etanercept. The authors noted that TNF alpha is involved in milk production, adding biological plausibility to the findings.[ 24 ]

Levels in milk

Maternal Levels. One woman received a single 40 mg of adalimumab subcutaneously at 4 weeks postpartum. Milk samples were obtained every 2 days for 8 days. A peak milk adalimumab level of 31 mcg/L was detected on day 6 after injection. Milk levels on days 5 and 8 were about 10 mcg/L.[ 12 ] Two women received adalimumab 40 mg subcutaneously for treatment of inflammatory bowel disease at unstated intervals. The first woman received the drug during pregnancy and postpartum. At 21 weeks postpartum and 7 days after the previous dose, her breastmilk adalimumab was 4.83 mcg/L while her serum level was 6.7 mg/L. In the second woman, the milk adalimumab concentration at 8 weeks postpartum and 9 days after the last dose was 4.88 mcg/L with a simultaneous serum concentration of 5.5 mg/L.[ 13 ] In a multi-center study of women with inflammatory bowel disease in pregnancy (the PIANO registry), 21 women receiving adalimumab provided milk samples at 1, 12, 24, and 48 hours after drug administration. Some also provided samples at 72, 96, 120, and 168 hours after drug administration. Two of the women had detectable ( 0.01 mg/L) adalimumab levels in milk. Peak concentrations in breastmilk were 0.45 and 0.71 mg/L and occurred at 12 to 24 hours after the dose. Seven women had undetectable milk adalimumab levels over a week of monitoring.[ 14 ] Infant Levels. A woman received adalimumab 40 mg subcutaneously at unstated intervals while breastfeeding (extent not stated). At 8 weeks postpartum and 9 days after the prior dose, the infant had an undetectable ( 0.65 mcg/L) adalimumab serum concentration.[ 13 ] 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 3 months of age, adalimumab was undetectable in the infant's serum.[ 15 ]

Alternatives LactMed lists

• Phototherapy
• Etanercept
• Infliximab