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Canakinumab use while Breastfeeding

Medically reviewed by Last updated on Jun 26, 2022.

Drugs containing Canakinumab: Ilaris

Canakinumab Levels and Effects while Breastfeeding

Summary of Use during Lactation

Preliminary information indicates that canakinumab levels in milk are very low to undetectable. It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is minimal. A few infants have been breastfed without noticeable harm. 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 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%.[4]

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).[5]

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.[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).[6]

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.[4]

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.[7]

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.[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]
Bosshard N, Zbinden A, Eriksson KK, et al. 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, et al. 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

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