Is Ocrelizumab safe while breastfeeding?

Effects on the breastfed infant

A retrospective cohort study from the German Multiple Sclerosis and Pregnancy Registry database identified 2 mothers who received ocrelizumab during breastfeeding. In one, the dose was 300 mg on day 20 postpartum and she nursed for 2.7 months after the dose. The second received 600 mg on day 194 postpartum and she nursed for 2.1 months after the dose. Blood counts were normal at well-baby visits at 59 and 39 days, respectively, after the dose and no abnormal infections had occurred. Another woman received rituximab 250 mg on day 55 postpartum and ocrelizumab 300 mg on day 333 postpartum. She breastfed for 22.9 months after the rituximab dose. Her infant had normal blood counts at 45 and 213 days after the rituximab dose, but had conjunctivitis and otitis media during this time.[ 6 ] Ocrelizumab exposure in breastmilk only had no effect on the B-cell count of one infant.[ 7 ] A retrospective study identified 4 patients with multiple sclerosis who received ocrelizumab 600 mg while breastfeeding (extent not stated). No adverse effects were reported in the infants.[ 8 ] A multicenter study of women who were receiving either ocrelizumab (n = 30) or rituximab (n = 15) for multiple sclerosis or neuromyelitis optica spectrum disorder followed their infants. Forty-three women breastfed their infants (n = 27 exclusively, n = 16 partially) for a median of 6.4 months (range 0.3 to 11.7). In the first 12 months of life, all infants grew and developed normally compared to WHO standards and a group of infants who were not breastfed. Beyond minor infections common to infancy, no unexpectedly severe or frequent infections arose. Four infants between the ages of 2.1 and 6.2 months who were breastfed after maternal ocrelizumab or rituximab had IgG and CD19 levels within the normal range.[ 3 ] Thirteen infants whose mothers were receiving ocrelizumab for multiple sclerosis were followed beginning at a median of 2 months of age. Eleven infants had one or more 1 adverse event, but they w

Effects on milk supply

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

Levels in milk

Maternal Levels. An international, multicenter study of patients with multiple sclerosis or neuromyelitis optica spectrum disorder collected breastmilk samples from 33 women who were receiving ocrelizumab. Milk samples were collected at a mean of 2.6 months (range 0.1 to 36) postpartum. The women received 300 mg once (n = 4) or twice (n = 10) or 600 mg (n = 16) and milk samples were collected before and up to 90 days after the dose. Where measurable (n = 16 samples), the peak concentration in milk usually occurred between 1 and 7 days after the dose. Milk concentrations were virtually undetectable at 90 days after a dose. For 4 women who received a single 300 mg dose, the average milk concentration was 0.08 mg/L, and the peak was 0.4 mg/L. For 10 women who receive a single 600 mg dose, the average milk concentration was 0.1 mg/L, and the peak was 0.3 mg/L. For 16 women who received two 300 mg doses, the average milk concentration was 0.08 mg/L and the peak was 0.2 mg/L. Based on the average milk levels, infants would receive a dose of 0.01 mg/kg daily.[ 3 ] Thirteen women with MS receiving ocrelizumab and their infants were enrolled at a median infant age of 2 months (range 0.5 to 5 months) at the time of drug infusion. The ocrelizumab levels in breastmilk resulted in a median average daily infant dosage of 45.1 mcg and a median RID of 0.27%.[ 4 ] Infant Levels. Six exclusively and 7 partially breastfed infants whose mothers were receiving ocrelizumab for multiple sclerosis had undetectable serum levels of the drug 30 days after the maternal drug infusion.[ 4 , 5 ]

Alternatives LactMed lists

• Immune Globulin
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