Is Tocilizumab safe while breastfeeding?

Effects on the breastfed infant

A pregnancy registry in Japan reported that two mothers resumed tocilizumab therapy while nursing their infants. No adverse events were reported in the infants, but details regarding extent of nursing, infant age, etc. are lacking.[ 12 ] Two women in Japan were treated with intravenous tocilizumab 400 mg monthly for rheumatoid arthritis while they reportedly breastfed their infants exclusively for 9 and 11 months, respectively. Neither infant experienced any adverse effects from the drugs and received all routine immunizations, including BCG without any adverse consequences.[ 6 ] It is possible that these two mothers are the same as those reported above. Three women with rheumatoid arthritis became pregnant while taking tocilizumab. The drug was stopped for the remainder of the pregnancy, but resumed (dose not stated) postpartum. They breastfed their infants (extent not stated). No infants had any adverse effects during the first year.[ 12 ] Three Australian women with rheumatoid arthritis were treated with tocilizumab monotherapy postpartum while taking tocilizumab (dosage not stated) and breastfeeding (extent not stated). None of their infants had any adverse outcomes at 1 year of age.[ 13 ] A woman was treated for adult onset Still's disease with tocilizumab 400 mg every 4 weeks, prednisolone 5 mg daily and tacrolimus 2 mg daily throughout pregnancy and postpartum. She breastfed almost exclusively postpartum while tocilizumab was continued every 4 weeks. Her infant developed no serious infections and demonstrated no developmental delay as of 6 months of age. The infant's routine childhood vaccinations included Haemophilus influenzae type b conjugate, hepatitis B, diphtheria, pertussis, tetanus, inactivated polio, and 13-valent pneumococcal polysaccharide vaccines. No live vaccines were given for the first 6 months postpartum. No adverse effects such as serious infections or immune reactions were seen.[ 7 ] A Japanese woman with rheumatoid arthritis was receiving

Effects on milk supply

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

Levels in milk

Maternal Levels. A woman with rheumatoid arthritis resumed tocilizumab at 5 weeks postpartum at a dose of 400 mg intravenously every month. Breastmilk concentrations were determined at 13, 18 and 22 weeks postpartum. The highest tocilizumab concentrations in milk occurred 3 days after the injection and was 68.2 mcg/L. The lowest concentration was 0.2 mcg/L at 34 days after the dose. Another mother resumed monthly tocilizumab 400 mg intravenously 9 days postpartum. Breastmilk concentrations were measured after the doses at 35 and 49 weeks postpartum. The highest concentrations occurred 3 days after the injection at 148.2 mcg/L and fell to 9 mcg/L after 28 days.[ 6 ] A woman was treated for adult onset Still's disease with tocilizumab 400 mg every 4 weeks, prednisolone 5 mg daily and tacrolimus 2 mg daily throughout pregnancy. The tocilizumab concentration in milk at 5 days postpartum (32 days after the previous dose) was 3.4 mcg/L. Another dose was given at 6 days postpartum. At about 19 hours later the milk level was 55.4 mcg/L; at 2.8 days after the dose the milk level was 215 mcg/L; at 18 days after the dose, the milk level was 70.4 mcg/L; at 28 days after the dose and before the next dose, the level was 3.8 mcg/L. Another dose was given on day 28. At about an hour after this dose the milk level was 48 mcg/L; 3 days later, the milk level was 205 mcg/L; at 11 days after the dose, the milk level was 127 mcg/L; at 17 days after the dose it was 65 mcg/L, and at 28 days after the dose it was 4.9 mcg/L.[ 7 ] The same authors measured trough tocilizumab concentrations in four other Japanese women with rheumatoid arthritis receiving the drug 400 mg every 4 weeks, comparing dried milk spots and liquid milk. The highest milk levels were reported on the day 3 sample and ranged from about 70 to 200 mcg/L. Levels fell to low to undetectable levels over the 28-day period. [ 8 ] A Japanese woman was treated during pregnancy with subcutaneous tocilizumab 162 mg every 2 weeks for

Alternatives LactMed lists

• Certolizumab Pegol
• Etanercept
• Infliximab