Can you take ocrelizumab while breastfeeding?

What LactMed would consider instead

LactMed ends this record by naming the drugs it would consider in place of ocrelizumab. Whether any of them fits depends on what you are treating — this is the database’s list, not a recommendation from us.

• Glatiramer
• Immune Globulin
• Interferon beta
• Methylprednisolone
• Natalizumab
• Ofatumumab,
• Peginterferon beta

How much ocrelizumab gets into breastmilk

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.

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%.

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.

What has been seen in breastfed infants

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. Ocrelizumab exposure in breastmilk only had no effect on the B-cell count of one infant.

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.

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.

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 were typical for the infant age, and none were serious. All infants had normal B-cell counts within the normal range for age. A follow-up found that the infants’ B-cell levels remained normal with normal response to childhood vaccines at 1 year of age in 11 infants who were followed.

An examination of data in the Roche global pharmacovigilance database covering November 5, 2008, to July 12, 2023, found breastfeeding exposure (defined as at least one maternal infusion while breastfeeding) for 122 infants. Of these infants, 7 breastfed infants had B-cell measurements, and none were abnormal. Five breastfed infants received live or live-attenuated vaccines with no reports of breakthrough infections following administration of common childhood vaccines and 9 (7.4%) infants had typical childhood infections reported compared to 12.2% of infants with no breastfeeding exposure to the drug. Six other breastfed infants had no reported infections and no data were reported for 107 infants. It is possible that some of these infants were reported separately above.

A review of 10 years of reports to the European adverse drug reaction database EudraVigilance found 6 unspecified serious adverse reactions reported in breastfed infants associated with ocrelizumab. Further details of the cases were not reported, so the causality cannot be verified.

A prospective single-center cohort study of infants, born in 2013 to 2022 were followed up at 6 to 36 months postpartum via telephone interviews. One hundred eighty-three infants who were breastfed during maternal monoclonal antibody therapy for multiple sclerosis or neuromyelitis optica spectrum disorder were matched to infants of disease-modifying therapy-naïve mothers. No differences were found in developmental delay, systemic antibiotic use, severe infections, or hospitalizations. Of the 183 infants, 34 were exposed to natalizumab.

A retrospective chart review found 8 term breastfed infants of multiple sclerosis patients who received ocrelizumab while breastfeeding, either exclusively, partially, or unknown. Ocrelizumab was reinitiated between 4 and 61.4 (median 10.4) weeks postpartum. Infants had their blood drawn at an average of 9.4 weeks after maternal drug initiation. Seven infants had CD19 counts that were within the normal range for age. One infant had a CD19 percentage of 8.2 that was below the normal laboratory range of 10.2 to 18.5%. This infant was delivered at 39 weeks of gestation with maternal reinitiation of ocrelizumab 600 mg at 4 weeks postpartum and infant blood draw 11 weeks postpartum. However, the distribution of B-cell subpopulations was considered to be normal for age. There was no increase in the number of infections noted in this infant.

Effects on milk supply

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