Ocrelizumab use while Breastfeeding

Summary of Use during Lactation

Amounts of ocrelizumab in milk are low and undetectable in the serum of breastfed infants. Many infants have been exposed to ocrelizumab during breastfeeding. No excess of infections or reductions of B-cells have been reported. Infant growth has been normal and no evidence of severe or persistent harm has been reported. Ocrelizumab appears to be acceptable to use during breastfeeding and breastfeeding can resume after the injection. Waiting for at least 2 weeks postpartum to resume therapy may minimize transfer to the infant.[1]

Drug Levels

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.[2]

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%.[3]

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.[3]

Effects 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.[4] Ocrelizumab exposure in breastmilk only had no effect on the B-cell count of one infant.[5]

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.[6]

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.[2]

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.[3,7]

One hundred eighty-three patients with multiple sclerosis or a related condition who received an anti-inflammatory monoclonal antibody were compared to 183 control patients. No differences were found in the annual rates of hospitalization, annual antibiotic use, or development of their breastfed (extent not stated) infants. Of the 183 patients, 34 received ocrelizumab.[8]

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.[9] It is possible that some of these infants were reported separately above

Effects on Lactation and Breastmilk

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

Alternate Drugs to Consider

(Multiple Sclerosis) Glatiramer, Immune Globulin, Interferon beta, Methylprednisolone, Peginterferon beta

References

1.

Krysko KM, Dobson R, Alroughani R, et al. Family planning considerations in people with multiple sclerosis. Lancet Neurol 2023;22:350-66. [PubMed: 36931808]

2.

Anderson A, Rowles W, Poole S, et al. Anti-CD20 monoclonal antibody therapy in postpartum women with neurological conditions. Ann Clin Transl Neurol 2023;10:2053-64. [PMC free article: PMC10647007] [PubMed: 37675826]

3.

Hellwig K, Oreja-Guevara C, Dobson R, et al. 175. B-cell levels in infants of lactating women with multiple sclerosis receiving ocrelizumab: SOPRANINO primary results. Mult Scler Relat Disord 2024;92:105951. doi:10.1016/j.msard.2024.106136 [CrossRef]

4.

Ciplea AI, Langer-Gould A, de Vries, A, et al. Monoclonal antibody treatment during pregnancy and/or lactation in women with MS or neuromyelitis optica spectrum disorder. Neurol Neuroimmunol Neuroinflamm 2020;7:e723. [PMC free article: PMC7188475] [PubMed: 32327455]

5.

Schwake C, Steinle J, Thiel S, et al. Neonatal B-cell levels and infant health in newborns potentially exposed to anti-CD20 monoclonal antibodies during pregnancy or lactation. Neurol Neuroimmunol Neuroinflamm 2024;11:e200264. [PMC free article: PMC11178251] [PubMed: 38870458]

6.

Chey SY, Kermode AG. Pregnancy outcome following exposure to ocrelizumab in multiple sclerosis. Mult Scler J Exp Transl Clin 2022;8:20552173221085737. [PMC free article: PMC8905230] [PubMed: 35284087]

7.

Bove R, Oreja-Guevara C, Hellwig K, et al. B-cell levels and breastmilk transfer in infants of lactating women with multiple sclerosis treated with ocrelizumab: Primary results of the prospective multicenter, open-label Phase IV study SOPRANINO. Mult Scler J 2024;30 (3S):38-40.

8.

Witt L, Thiel S, Gold R, et al. Child development after exposure to monoclonal antibodies during breastfeeding. Neurology 2024;102:Suppl 1. doi:10.1212/WNL.0000000000204895 [CrossRef]

9.

Vukusic S, Bove R, Dobson R, et al. Pregnancy and infant outcomes in women with multiple sclerosis treated with ocrelizumab. Neurol Neuroimmunol Neuroinflamm 2025;12:e200349. [PMC free article: PMC11655168] [PubMed: 39689270]

Substance Name

Ocrelizumab

CAS Registry Number

637334-45-3

Drug Class

Breast Feeding

Lactation

Milk, Human

Biological Response Modifiers

Immunologic Adjuvants

Antibodies, Monoclonal