Is Anakinra safe while breastfeeding?
Here is what LactMed, the Drugs and Lactation Database published by the U.S. National Institute of Child Health and Human Development (NICHD), reports about Anakinra. The text below is quoted from that source — it is not our own verdict.
Summary of use during breastfeeding
Anakinra is the pharmaceutical name for recombinant human interleukin-1 receptor antagonist (IL-1Ra). IL-1Ra is a normal component of human milk where it may play a role as an anti-inflammatory agent. Many infants have been breastfed during maternal anakinra therapy, occasionally in conjunction with colchicine, with no obvious adverse effects or infections. Several international guidelines state that the drug is a low risk to the nursing infant and acceptable to use during breastfeeding.[1-3]
Effects on the breastfed infant
A woman was receiving anakinra 100 mg daily for adult-onset Still's disease during pregnancy and lactation. Her breastfed (extent not stated) infant gained wight and appeared to have normal psychomotor development during an unspecified follow-up period.[6]
Among a cohort of 18 women with term pregnancies treated with anakinra for cryopyrin-associated periodic syndromes during pregnancy, 3 of the women breastfed their infants (extent not stated) for periods of <1 month, 3 months and 1 year. No adverse neonatal outcomes were reported.[7]
In an international multicenter study of mothers exposed to interleukin-1 receptor antagonists, 10 babies were breastfed (extent not stated) by mothers receiving anakinra for up to 10 months. No infections or developmental abnormalities were reported.[8] Three of the cases had been reported previously in reference[7].
Of 5 women who took anakinra during pregnancy, two breastfed their infants while continuing to receive anakinra 100 mg daily. No serious infections were reported and development was normal.[9]
A woman was treated with anakinra 100 mg subcutaneously once daily and oral colchicine 1 mg twice daily during pregnancy and postpartum for familial Mediterranean fever while she breastfed her infant (extent not stated). At 9 months of age, the infant’s development was within normal range. The routine vaccination schedule for the baby was being performed on time and there was no history of infection in the infant.[10]
A woman with juvenile idiopathic arthritis was treated until 19 weeks of pregnancy with anakinra 100 mg daily by subcutaneous injection. It was discontinued for the duration of the pregnancy and then restarted 2 weeks after delivery while she partially breastfed her infant. No adverse reactions were reported.[11]
A woman with recurrent pericarditis was treated with subcutaneous anakinra 100 mg once weekly beginning in the fifth month of pregnancy and continuing postpartum. She also took colchicine 0.5 mg daily. She delivered twins by cesarean section at 36 weeks of gestation and breastfed (extent not stated) her infants up to 18 months of age. No health problems were noted in the infants up to 18 months of age.[12]
A woman with persistent colchicine-resistant pericarditis took anakinra throughout her pregnancy and at a dose of 100 mg twice weekly during breastfeeding (extent not stated) for 12 months and is still following this regimen. The child’s growth and development were normal with no reported infections or developmental abnormalities.[13]
A case series reported 10 mothers from 4 European countries who were treated with anakinra for pericarditis who breastfed their infants (extent not stated), including one woman who breastfed two infants following 2 pregnancies. Doses ranged from 100 mg once a week to 100 mg once daily. Two of the women also took colchicine 1 mg daily. The infants had no reported infections or developmental abnormalities.[14]
A French teratogen information service reviewed all patients exposed to anakinra during pregnancy over a 16-year period. In 3 retrospective and 5 prospective cases mothers breastfed while taking anakinra. No notable effects were reported in the infants. The extent of breastfeeding was not reported for most cases, but among the retrospectively followed cases, one mother breastfed for 12 months and one for 18 months. Follow-up was 22 and 51 months in two infants.[15]
Effects on milk supply
Relevant published information was not found as of the revision date.
Levels in milk
Maternal Levels. The concentration of IL-1Ra in colostrum in 88 normal mothers was 672 ng/L, which was higher than the plasma concentration. Mature milk levels were lower than those in colostrum. Samples collected over a period of 2 to 6 months postpartum indicated that mothers continued to excrete IL-1Ra during this time.[4] Mothers with acute mastitis had slightly higher average levels of IL-1Ra than levels after recovery, but the median values were the same. The levels found in these mothers were the same as those of control mothers.[5]
Infant Levels. Relevant published information was not found as of the revision date.
Alternatives LactMed lists
Source: Drugs and Lactation Database (LactMed), National Institute of Child Health and Human Development (NICHD), via NCBI Bookshelf, record “Anakinra” (LM953). LactMed on NCBI Bookshelf. LactMed is a registered trademark of the U.S. Department of Health and Human Services.
Educational summary of an authoritative source — not medical advice. Never start, stop, or change a medicine while breastfeeding without confirming with your doctor.