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Drugs and Lactation Database (LactMed®) [Internet]. Bethesda (MD): National Institute of Child Health and Human Development; 2006-.

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Drugs and Lactation Database (LactMed®) [Internet].

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Last Revision: November 15, 2023.

Estimated reading time: 3 minutes

CASRN: 914613-48-2

Drug Levels and Effects

Summary of Use during Lactation

Preliminary information and computer models indicate that canakinumab levels in milk are very low to undetectable.[1] It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal.[2] A few infants have been breastfed without noticeable harm and some professional guidelines consider canakinumab to be acceptable during breastfeeding.[3] Until more data become available, canakinumab injection should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. Waiting for at least 2 weeks postpartum to resume therapy may minimize transfer to the infant.[4] Topical or homeopathic preparations pose little risk to the nursing infant.

Drug Levels

Maternal Levels. A patient with Muckle-Wells syndrome received canakinumab 150 mg subcutaneously on day 10 postpartum to treat a worsening of her disease. The median concentration of canakinumab in milk samples collected on days 1 to 9 and day 13 after the dose was 14 mcg/L (range 3.8 to 23 mcg/L). The weight-adjusted relative infant dose was estimated to be 0.08%.[5]

A woman with systemic juvenile idiopathic arthritis received canakinumab 150 mg every 4 weeks during pregnancy. A breast milk sample taken day 4 postpartum (14 days after the last injection), found no detectable canakinumab (<0.5 mcg/mL).[6]

Infant Levels. A patient with Muckle-Wells syndrome received canakinumab 150 mg subcutaneously on day 10 postpartum to treat a worsening of her disease. Although the infant was born with a level of 1.33 mg/L in cord blood from 2 maternal doses given during pregnancy, and the mother continued to partially breastfeed her infant, no detectable canakinumab (assay limit not stated) was found in the serum of the infant 10 weeks after the postpartum dose.[5]

Effects in Breastfed Infants

In an international multicenter study of mothers exposed to interleukin-1 receptor antagonists, 4 babies were breastfed (extent not stated) by mothers receiving regular canakinumab. It is unclear if mothers received the drug postpartum or only during pregnancy. There were no reported serious infections and no developmental abnormalities at a mean follow-up of 2.2 years (range 5 months to 4 years).[7]

A patient with Muckle-Wells syndrome received canakinumab 150 mg subcutaneously at 10 days postpartum to treat a worsening of her disease. She partially breastfed her infant. The child developed normally in the following 2 years, with a normal height and weight at 2 years of age. All vaccines were given including the first live-attenuated vaccine at 12 months of age.[5]

Two patients, one with Muckle-Wells syndrome and one with familial Mediterranean fever, received canakinumab throughout pregnancy and lactation in doses of 150 mg given every 4 to 8 weeks. They both breastfed their infants, one for 8 months and one for 16 months (extent of nursing not stated). No infections were reported in the infants during their first 6 months and no severe or frequent infections occurred during their first 2 years. All childhood vaccines were administered on schedule except BCG, which was postponed until 3 months. Anti-hepatitis B surface antigen titers of both infants were in the normal range at 6 months and 2 years, indicating an adequate response.[8]

Two infants were breastfed by mothers who received canakinumab during pregnancy and postpartum. No serious infections or developmental abnormalities were reported at an average follow-up of nine months.[6]

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.


Stratigakis A, Paty D, Zou P, et al. A regression approach for assessing large molecular drug concentration in breast milk. Reprod Breed 2023;3:199-207. doi:10.1016/j.repbre.2023.10.003 [CrossRef]
Anderson PO. Monoclonal antibodies during breastfeeding. Breastfeed Med 2021;16:591-3. [PubMed: 33956488]
Russell MD, Dey M, Flint J, et al. British Society for Rheumatology guideline on prescribing drugs in pregnancy and breastfeeding: Immunomodulatory anti-rheumatic drugs and corticosteroids. Rheumatology (Oxford) 2023;62:e48-e88. [PMC free article: PMC10070073] [PubMed: 36318966]
Krysko KM, Dobson R, Alroughani R, et al. Family planning considerations in people with multiple sclerosis. Lancet Neurol 2023;22:350-66. [PubMed: 36931808]
Bosshard N, Zbinden A, Eriksson KK, Förger F. Rituximab and canakinumab use during lactation: No detectable serum levels in breastfed infants. Rheumatol Ther 2021;8:1043-8. [PMC free article: PMC8217349] [PubMed: 33999372]
Weber E, Millet A, Beghin D, et al. Safety of canakinumab during pregnancy: Seven new cases. Rheumatology (Oxford) 2022;61:e229-e231. [PubMed: 35325056]
Youngstein T, Hoffmann P, Gul A, et al. International multi-centre study of pregnancy outcomes with interleukin-1 inhibitors. Rheumatology (Oxford) 2017;56:2102-8. [PMC free article: PMC6251516] [PubMed: 28968868]
İlgen U, Eyüpoğlu Ş, Yayla ME, Küçükşahin O. Fetal exposure to canakinumab: A report of three pregnancies. Clin Rheumatol 2022;41:1261–3. [PubMed: 35018583]

Substance Identification

Substance Name


CAS Registry Number


Drug Class

Breast Feeding


Milk, Human

Antibodies, Monoclonal

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. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

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Attribution Statement: LactMed is a registered trademark of the U.S. Department of Health and Human Services.

Bookshelf ID: NBK500580PMID: 29999640


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