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Ocrelizumab use while Breastfeeding

Drugs containing Ocrelizumab: Ocrevus

Medically reviewed by Drugs.com. Last updated on Jan 16, 2021.

Ocrelizumab Levels and Effects while Breastfeeding

Summary of Use during Lactation

A few infants have been exposed to ocrelizumab during breastfeeding, with no clearcut evidence of harm. No information is available on the excretion of ocrelizumab into breastmilk. Because ocrelizumab is a large protein molecule with a molecular weight of about 148,000 Da, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant's gastrointestinal tract. Until more data become available, ocrelizumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant.

Drug Levels

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

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 2019 in clinical trials and postmarketing surveillance found 3 infants who had been breastfed during maternal ocrelizumab therapy for multiple sclerosis. Two infants were exposed to the drug in breastmilk, but no other data were available. A third infant was exposed in breastmilk and had a slight decrease in B cells at 1 month of age, which returned to normal after 1 week.[1]

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 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.[2]

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.
Oreja-Guevara C, Wray S, Buffels R, et al. Pregnancy outcomes in patients treated with ocrelizumab. ECTRIMS Online Library 2019. https:​//onlinelibrary​.ectrims-congress.eu​/pdfviewer/web/viewer​.html?file=https%3A//onlinelibrary​.ectrims-congress​.eu/ectrims​/download/poster%3Fcm_id%3D282372.
2.
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]

Substance Identification

Substance Name

Ocrelizumab

CAS Registry Number

637334-45-3

Drug Class

Breast Feeding

Lactation

Biological Response Modifiers

Immunologic Adjuvants

Antibodies, Monoclonal

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Further information

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