Question

I am a breastfeeding mother and i want to know if it is safe to use Adalimumab? Is Adalimumab safe for nursing mother and child? Does Adalimumab extracts into breast milk? Does Adalimumab has any long term or short term side effects on infants? Can Adalimumab influence milk supply or can Adalimumab decrease milk supply in lactating mothers?

Adalimumab lactation summary

Adalimumab is safe in breastfeeding
  • DrLact safety Score for Adalimumab is 1 out of 8 which is considered Safe as per our analyses.
  • A safety Score of 1 indicates that usage of Adalimumab is mostly safe during lactation for breastfed baby.
  • Our study of different scientific research also indicates that Adalimumab does not cause any serious side effects in breastfeeding mothers.
  • Most of scientific studies and research papers declaring usage of Adalimumab safe in breastfeeding are based on normal dosage and may not hold true for higher dosage.
  • Score calculated using the DrLact safety Version 1.2 model, this score ranges from 0 to 8 and measures overall safety of drug in lactation. Scores are primarily calculated using publicly available case studies, research papers, other scientific journals and publically available data.

Answer by Dr. Ru: About Adalimumab usage in lactation

IgG1-monoclonal antibody directed against tumor necrosis factor used for treatment of auto-immune diseases like Rheumatoid Arthritis. Minimal or low excretion into breast milk due to high molecular weight. In breastfed babies whose mothers were on this medication plasma levels were undetectable and failed to show side effects. It should be avoid in the first two post-partum weeks since pass of significant amounts of IgG to the milk can occur in the first 3 - 4 post-partum days.

Answer by DrLact: About Adalimumab usage in lactation

Limited information indicates that maternal adalimumab injections produce low levels in breastmilk and do not adversely affect the nursing infant. Because adalimumab is a large protein molecule with a molecular weight of about 148,000, absorption is unlikely because it is probably destroyed in the infant's gastrointestinal tract. Most experts feel that the drug is probably safe during nursing.[1][2][3][4][5][6][7][8] However, until more data become available, adalimumab should be used with caution while nursing a newborn or preterm infant.

Adalimumab Side Effects in Breastfeeding

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.[12] The authors reported a brief follow-up stating that the woman also breastfed her second infant during adalimumab therapy with no adverse consequences.[13] 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.[14] 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.[10] 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.[11] 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.[15] 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.[16] 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.[8]

Alternate Drugs

Tocilizumab(Low Risk)
Daclizumab(Low Risk)
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Abatacept(Low Risk)
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Leflunomide(Dangerous)
Methotrexate(Low Risk)
Isotretinoin(Unsafe)
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Hydroquinone(Low Risk)
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Ustekinumab(Low Risk)
Pimecrolimus(Low Risk)
Docusate(Safe)
Cascara Sagrada(Low Risk)
Rifaximin(Safe)
Dimenhydrinate(Low Risk)
Droperidol(Low Risk)
Bisacodyl(Safe)
Cisapride(Safe)
Ursodiol(Safe)
Alosetron(Low Risk)
Cimetidine(Low Risk)
Senna(Safe)
Cyclizine(Low Risk)
Doxylamine(Unsafe)
Disclaimer: Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. We do not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.