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Canakinumab use while Breastfeeding

Drugs containing Canakinumab: Ilaris

Medically reviewed by Last updated on Jan 11, 2021.

Canakinumab Levels and Effects while Breastfeeding

Summary of Use during Lactation

Preliminary information indicates that canakinumab levels in milk are very low. It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal. Until more data become available, canakinumab injection should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. Topical or homeopathic preparations pose little risk to the nursing infant.

Canakinumab is a human immunoglobulin G1 (IgG1) kappa antibody. Holder pasteurization (62.5 degrees C for 30 minutes) decreases the concentration of endogenous immunoglobulin G by up to 79%.[1,2] A study of 67 colostrum samples that underwent Holder pasteurization found that IgG amounts decreased by 34 to 40%. Specific IgG subclasses decreased by different amounts, with IgG1 activity decreasing by about 37%.[3] None of the studies measured IgG activity.

Drug Levels

Maternal Levels. A patient with Muckle-Wells syndrome received canakinumab 150 mg subcutaneously to treat a worsening of her disease ten days postpartum. She continued to breastfeed her child. The average concentration of canakinumab in milk samples collected on 10 consecutive days was 15.8 ng/ml. The average daily infant dose was 0.002 mg/kg, which tanslates to a relative infant dose of 0.11%.[4]

Infant Levels. A patient with Muckle-Wells syndrome received canakinumab 150 mg subcutaneously to treat a worsening of her disease ten days postpartum. She continued to breastfeed her child. There was no detectable canakinumab in the serum of the infant. The extent of nursing, timing of the blood sample and lower limit of the assay were not reported.[4]

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).[5]

Effects on Lactation and Breastmilk

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


Koenig A, de Albuquerque Diniz EM, Barbosa SF, et al. Immunologic factors in human milk: The effects of gestational age and pasteurization. J Hum Lact. 2005;21:439–43. [PubMed: 16280560]
Adhisivam B, Vishnu Bhat B, Rao K, et al. Effect of Holder pasteurization on macronutrients and immunoglobulin profile of pooled donor human milk. J Matern Fetal Neonatal Med. 2019;32:3016–9. [PubMed: 29587541]
Rodríguez-Camejo C, Puyol A, Fazio L, et al. Antibody profile of colostrum and the effect of processing in human milk banks: Implications in immunoregulatory properties. J Hum Lact. 2018;34:137–47. [PubMed: 28586632]
Zbinden A, Eriksson K, Forger F. Low concentrations of biologic DMARDs in breastmilk of patients treated during lactation. Ann Rheum Dis 2020;79:1933. Abstract. doi: 10.1136/annrheumdis-2020-eular.4431. [CrossRef]
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]

Substance Identification

Substance Name


CAS Registry Number


Drug Class

Breast Feeding


Antibodies, Monoclonal

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Further information

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