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    Ocrevus (ocrelizumab) IV

    Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) SC

    IV = Intravenous, SC = Subcutaneous

    Ocrevus® Prescribing Information
    Ocrevus® Medication Guide
    Ocrevus Zunovo® Prescribing Information
    Ocrevus Zunovo® Medication Guide

    Safety Data Sheets:

    Ocrevus® Vials (300 mg/10 mL)
    Ocrevus Zunovo® Vials (920 mg ocrelizumab and 23,000 units hyaluronidase per 23 mL)

    Healthcare Provider Letters:

    Ocrevus® Important Drug Warning - August 2025
    Ocrevus Zunovo® Important Drug Warning - August 2025
    Woman holding baby icon

    Safety Topic: Pregnancy and Lactation in Multiple Sclerosis (MS)

    SECTIONS ON THIS PAGE

    Family Planning
    Pregnancy and Infant Outcomes
    Resources
    Abbreviations

    The information in this section may include content beyond what is in the FDA-approved label. Because the US Food and Drug Administration (FDA) has not approved such content, no conclusions regarding safety or efficacy may be made. Providing this information should not be construed as a recommendation for use of a Genentech product for unapproved uses. For FDA-approved products, please consult the full prescribing information for a complete discussion of risks and benefits of the product(s) for its approved indication(s).

    Pregnancy and Infant Data

    View data from the Roche Global Safety Database presented at CMSC 2026.

    Explore the Data

    Family Planning

    Proactive Family Planning Discussions Can Be Useful to Women With MS Who Are of Childbearing Age

    3x women icon

    Women are 3 times more likely than men to have MS1-4

    ~30 years calendar icon

    With peak onset at ~30 years of age, MS mostly affects women of childbearing age2

    1 in 3 women icon

    1/3 of women with MS will have children after their diagnosis2,4

    Women With MS Who Plan to Conceive Report Numerous Disease-Related Concerns

    35% (n=116/332) of participants with MS surveyed felt that MS significantly impacted their decision to have children.1

    Concerns among patients surveyed1:

    Management of Disease-Modifying Therapies (DMTs) Includes Assessing Benefits and Risks to Both the Mother and Fetus

    Clipboard with prescription icon

    Treatment recommendations vary by medication, and product-specific prescribing information should be considered

    Hand and stop sign icon

    General recommendations are to discontinue DMTs temporarily prior to conception3-8

    Man, woman, and child icon

    Certain DMTs are associated with an increased risk of rebound upon cessation3,5,6,9,10

    Product bottle with arrow icon

    Recommended washout periods for DMTs should be considered to mitigate the risks of fetal exposure, especially in the case of DMTs with teratogenic potential8,11,12

    References

    1. Bonavita S, et al. Front Neurol. 2021;12:620772.
    2. Bove RM, et al. Continuum (Minneap Minn). 2022;28(1):12-33.
    3. Krysko KM, et al. Lancet Neurol. 2023;22(4):350-366.
    4. Mendibe Bilbao M, et al. Neurologia (Engl Ed). 2019;34(4):259-269.
    5. Gklinos P, et al. Pharmaceuticals (Basel). 2023;16(5):770.
    6. Rae-Grant A, et al. Neurology. 2018;90(17):777-788.
    7. Pregnancy and reproduction issues. National MS Society. Accessed June 4, 2023. https://www.nationalmssociety.org/​Living-Well-With-MS/Diet-Exercise-Healthy-Behaviors/Pregnancy.
    8. Villaverde-Gonzalez R. Degener Neurol Neuromuscul Dis. 2022;12:1-21.
    9. Dobson R, et al. Pract Neurol. 2023;23(1):6-14.
    10. Tisovic K, et al. Biomedicines. 2019;7(2):32.
    11. Krysko KM, et al. Curr Treat Options Neurol. 2021;23(4):11.
    12. Coyle PK. Ther Adv Neurol Disord. 2016;9(3):198-210.

    Pregnancy and Infant Outcomes

    At the 2026 Consortium of Multiple Sclerosis Centers (CMSC) annual meeting, Genentech presented data related to pregnancy and lactation from the Roche Global Safety Database.

    Roche Global Safety Database Analysis13

    Sources Reporting Period Reporting Type
    Interventional or non-interventional clinical studies, spontaneous reports, non-interventional program, published literature Reporting Period 2008 to March 2025
    • Prospective: Final outcomes were unknown at initial notification (n=3,803)
    • Retrospective: Final outcomes were known at initial notification (n=1,290)

    Due to the nature of post-marketing adverse event reports, information may be incomplete

    Timing of last OCR dose in relation to date of LMP (months)

    • No in utero exposure: Defined as no exposure to ocrelizumab in utero if the last infusion was more than 3 months prior to LMP
    • In utero exposure: Defined as exposure to ocrelizumab in utero if the last infusion was within 3 months of LMP or during pregnancy

    Rationale for exposure classification:

    • Drug elimination: Elimination from the body typically occurs around 5 half-lives, which for OCR is approximately equivalent to 4.5 months (based on an OCR half-life of ~26 days)14,15
    • First trimester: Assumption that no relevant placental transfer of IgG1 antibodies occurs in the first trimester of pregnancy16,17
    1. Exposure classification is based on OCR t1/2=26 days (full elimination from the body is expected by approximately 4.5 months) and assuming no relevant placental transfer of IgG1 antibodies occurs prior to 12 weeks of gestation13,14.

    Roche Global Safety Database Analysis: Pregnancy Outcomes by Exposure13,b,c

    Swipe to see the full table

      Prospective Cases With Known Outcomes  
      NON-EXPOSED
    (n=644)    		 EXPOSED
    (n=836)    		 TOTALd
    (n=1892)    		 GENERAL POPULATION
    Live birthse 89.8% 87.0% 85.1% 70.2%18
    Full term (≥37 weeks)f 66.2% 63.1% 58.0% -
    Preterm (<37 weeks)f 6.7% 8.7% 7.7% 6.5-10.4%18,19,21
    Unknown gestational agef 27.0% 28.2% 34.3% -
    Live births with MCAf 1.7% 2.2% 1.7% 2.7-4.0%18,20
    Ectopic pregnancye 0.6% 0.6% 0.7% 1.1-2.0%18,19
    Elective terminatione 1.6% 5.3% 3.9% 18.2%18
    Intrauterine fetal deathe
    Spontaneous abortion, ≤22 weeks 8.1% 6.7% 9.9% 10-20%18,19
    Stillbirth, >22 weeks - 0.4% 0.2% 0.2-0.7%18-21

    The developmental risk associated with the use of Ocrevus in pregnant women has not been determined. Women of childbearing potential should use effective contraception while receiving Ocrevus and for 6 months after the last infusion of Ocrevus.14 Please consult the Ocrevus Prescribing Information and the Ocrevus Zunovo Prescribing Information.

    1. The dash indicates that no cases were reported.
    2. In utero exposure based on timing of last OCR dose relative to LMP.
    3. "Total" includes prospective cases with known outcomes: not exposed in utero, exposed in utero, and unknown exposure.
    4. Percentages represent fractions of the total known outcomes of the respective exposure categories (not exposed in utero, exposed in utero, total).
    5. Percentages represent fractions of the total live births for the respective exposure categories (not exposed in utero, exposed in utero, total).

    References

    1. Krysko K et al. A Decade of Pregnancy Outcomes in Women With Multiple Sclerosis Receiving Ocrelizumab: Analysis of Over 5000 Pregnancies. Presentation presented at CMSC Annual Meeting; May 27–29, 2026; North Carolina, USA.
    2. Ocrevus. Prescribing Information. Accessed Feb 10, 2025. https://www.gene.com/​download/​pdf/​ocrevus_prescribing.pdf.
    3. Gibiansky E, et al. Br J Clin Pharmacol. 2021;87(6):2511-2520.
    4. Palmeira P, et al. Clin Dev Immunol. 2012;2012:985646.
    5. Simister NE. Vaccine. 2003;21(24):3365-3369.
    6. Anderson et al. EJN. 2022;30(1):162-171.
    7. Khan E, et al. J Neuroimmunol. 2023;383:578178.
    8. MacDonald SC, et al. Am J Epidemiol. 2019;188(1):57-66.
    9. Lopez-Leon S, et al. J Neurol. 2020;267(9):2721-2731.

    Resources

    Explore additional resources related to this safety topic.

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    CMSC 2026 Poster

    See the full data from the Roche Global Safety Database presented at CMSC 2026.

    View on Medically

    Publications

    Pregnancy and Infant Outcomes in Women With Multiple Sclerosis Treated With Ocrelizumab

    Vukusic S, Bove R, Dobson R, et al. Neurol Neuroimmunol Neuroinflamm. 2025;12:e200349. doi: 10.1212/​NXI.0000000000200349.

    View Publication

    Congresses

    A Decade of Pregnancy Outcomes in Women With Multiple Sclerosis Receiving Ocrelizumab: Analysis of Over 5000 Pregnancies

    Krysko K, Dobson R, Vukusic S, et al. Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting; May 27–29, 2026; Charlotte, NC, USA

    View CMSC 2026 Presentation

    Humoral responses and 1-year follow up of infants potentially exposed to ocrelizumab during pregnancy and breastfeeding: final analysis of the prospective, multicentre, open-label, phase IV studies MINORE and SOPRANINO

    Bove R, Hellwig K, Dobson R, et al. Mult Scler J. 2025;31(3S):99-100.

    View ECTRIMS 2025 Presentation

    Maternal and infant pregnancy outcomes in women with MS who received ocrelizumab versus a comparator MS population: results of the Ocrelizumab Pregnancy Registry

    Hellwig K, Ferreira G, Duran Pacheco GC, et al. Mult Scler J. 2025;31(3S):197.

    View ECTRIMS 2025 Poster

    Placental and Breastmilk Transfer of Ocrelizumab From Women With Multiple Sclerosis to Infants and Potential Impact on B-Cell Levels: The MINORE and SOPRANINO Trials

    Riley B, Celia O, Sandra V, et al. Presented at the 2025 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC); May 28–31, 2025; Phoenix, AZ, USA

    View CMSC 2025 Presentation

    Disease Activity Before, During and After Pregnancy in Women with MS Receiving Ocrelizumab: An Integrated Analysis From 13 Interventional Clinical Trials

    Vukusic S, Ross A, Oreja-Guevera C, et al. Presented at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis Meeting; September 18 - 20, 2024. ECTRIMS Poster #P591

    View ECTRIMS 2024 Poster

    Congresses

    Design of the Ocrelizumab Pregnancy Registry to Assess Maternal, Fetal and Infant Outcomes in Women With Multiple Sclerosis Who Were Exposed to Ocrelizumab During, or Within 6 Months Before, Pregnancy

    Wormser D, Engel P, Hahn K, et al. Presented at: American Academy of Neurology Annual Meeting; April 21–27, 2018; Los Angeles, CA, USA.

    View AAN 2018 Poster

    Design of a Multi-Source Post-Marketing Study to Evaluate Pregnancy and Infant Outcomes in Women With Multiple Sclerosis Who Were Exposed to Ocrelizumab During, or Within 6 Months Before, Pregnancy

    Margulis AV, Andrews EB, Hernandez-Diaz S, et al. Presented at: American Academy of Neurology Annual Meeting; April 21–27, 2018; Los Angeles, CA, USA.

    View AAN 2018 Poster

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    TOP

    • CMSC
      Consortium of Multiple Sclerosis Centers

    • DMT
      Disease-modifying therapy

    • ECTRIMS
      European Committee for Treatment and Research in Multiple Sclerosis

    • FDA
      Food and Drug Administration

    • IgG1
      Immunoglobulin G1

    • LMP
      Last menstrual period

    • MCA
      Major congenital anomalies

    • MS
      Multiple sclerosis

    • OCR
      OCREVUS (ocrelizumab)

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