Anifrolumab use while Breastfeeding

Summary of Use during Lactation

No information is available on the clinical use of anifrolumab during breastfeeding. Because anifrolumab is a large protein molecule with a molecular weight of 148,000 Da, the amount in milk is likely to be 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, anifrolumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant.

Anifrolumab is an immunoglobulin G1 (IgG1) 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 Holder pasteurization having little effect on IgG4 activity.[3] None of the studies measured IgG activity.

Drug Levels

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

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

Effects in Breastfed Infants

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

Effects on Lactation and Breastmilk

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

References

1.

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]

2.

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]

3.

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]

Substance Name

Anifrolumab

CAS Registry Number

1326232-46-5

Drug Class

Breast Feeding

Lactation

Milk, Human

Antibodies, Monoclonal, Humanized