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Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-.

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Ocrelizumab

Last Revision: May 15, 2022.

Estimated reading time: 3 minutes

CASRN: 637334-45-3

Drug Levels and Effects

Summary of Use during Lactation

Amounts of ocrelizumab in milk are low and absorption is unlikely because it is a large molecule that is probably partially destroyed in the infant's gastrointestinal tract. Several infants have been exposed to ocrelizumab during breastfeeding, with normal growth and no evidence of severe or persistent harm. Ocrelizumab appears to be acceptable to use during breastfeeding.[1]

Drug Levels

Maternal Levels. A multicenter study collected breastmilk samples from 23 women who were receiving ocrelizumab for multiple sclerosis. The women received 300 mg or 600 mg once or twice and milk samples were collected before and up to 90 days after the dose. Of 206 milk samples, only 38 were above the detection limit of 160 mcg/L, with a median average concentration of 159 mcg/L (range 159-272 mcg/L. The highest concentration occurred at 7 days after the dose in most patients. The estimated mean infant dosage was 24 mcg/kg daily. Milk concentrations were virtually undetectable at 90 days after a dose.[1]

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

Effects in Breastfed Infants

A summary of pregnancies that occurred up to March 27, 2020 in clinical trials and postmarketing surveillance found 6 infants who had been breastfed during maternal ocrelizumab therapy for multiple sclerosis. Five infants were exposed to the drug in breastmilk, but no other data were available. One infant was exposed via breastmilk alone and had a slight decrease in B cells at 1 month of age, which returned to normal after 1 week. Another infant who was exposed during pregnancy and via breastmilk had excessive vomiting and swelling, but it was thought to be a potential dairy allergy.[2]

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.[3] It is possible that these infants were include in the postmarketing surveillance above.

A multicenter study collected breastmilk samples from 23 women who were receiving ocrelizumab 300 mg or 600 mg once or twice for multiple sclerosis. Fourteen of the mothers breastfed their infants for at least 2 weeks after the infusion. All infants with data available (n = 20) had normal heights and weights at 6 months (n = 3) and 1 year of age (n = 17). Mothers completed the Ages and Stages questionnaire up to 12 months and of 19 infants with available data, all were above normal cutoff at 6 months (n = 3) and 12 months (n = 16).[1]

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.[4]

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.
Anderson A, Jacobs D, LaHue SC, et al. Ocrelizumab in postpartum women with multiple sclerosis: Low transfer into breast milk and reassuring infant development in a multicenter cohort. actrims 2022 Forum;February 25, 2022:Session PS2. Abstract P413. https://www​.abstractsonline​.com/pp8/#!/10495​/presentation/495.
2.
Tailor K, Bove R, Oreja-Guevara C, et al. P1132. Pregnancy outcomes in patients treated with ocrelizumab. Presented at MSVirtual2020, the 8th Joint ACTRIMS-ECTRIMS meeting 2020. https://library​.msvirtual2020​.org/virtual-library-search?product_id=7.
3.
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:e273. [PMC free article: PMC7188475] [PubMed: 32327455]
4.
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]

Substance Identification

Substance Name

Ocrelizumab

CAS Registry Number

637334-45-3

Drug Class

Breast Feeding

Lactation

Milk, Human

Biological Response Modifiers

Immunologic Adjuvants

Antibodies, Monoclonal

Disclaimer: Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

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