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Ocrevus (ocrelizumab) IV

Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) SC

IV = Intravenous, SC = Subcutaneous

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

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 ECTRIMS 2024.

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 2024 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 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 2024
  • Prospective: Final outcomes were unknown at initial notification (n=3,022)
  • Retrospective: Final outcomes were known at initial notification (n=962)

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=454)
EXPOSED
(n=655)
TOTALd
(n=1,502)
GENERAL POPULATION
Live birthse 89.2% 85.8% 84.4% 70.2%18
Full term (≥37 weeks)f 72.3% 66.5% 61.4% -
Preterm (<37 weeks)f 8.1% 8.5% 8.0% 6.5-10.4%18-21
Unknown gestational agef 19.5% 24.9% 30.7% -
Live births with MCAf 1.5% 1.8% 1.3% 2.7-4.0%18,20
Ectopic pregnancye 0.7% 0.6% 0.9% 1.1-2.0%18,19
Elective terminatione 1.8% 6.3% 4.7% 18.2%18
Intrauterine fetal deathe
Spontaneous abortion, ≤22 weeks 8.4% 6.9% 9.8% 10-20%18,19
Stillbirth, >22 weeks - 0.5% 0.2% 0.2-0.7%18,20

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. Dobson R, et al. Pregnancy and Infant Outcomes in Women with Multiple Sclerosis Receiving Ocrelizumab: Analysis of Approximately 4,000 Pregnancies to Date. Poster presented at: ECTRIMS Annual Meeting; September 18-20, 2024; Copenhagen, Denmark.
  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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ECTRIMS 2024 Poster

See the full data from the Roche Global Safety Database presented at ECTRIMS 2024.

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.

Congresses

Pregnancy and Infant Outcomes in Women with Multiple Sclerosis Receiving Ocrelizumab: Analysis of Approximately 4,000 Pregnancies to Date

Dobson R, Vukusic S, Bove R, et al. Presented at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis in Copenhagen, Denmark; September 18-20, 2024. ECTRIMS Poster P085.

B-Cell Levels and Placental Transfer in Infants Potentially Exposed to Ocrelizumab During Pregnancy: Primary Analysis of the Prospective Multicentre, Open-Label Phase IV MINORE Study

Hellwig K, Bove R, 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 #P087

B-Cell Levels and Breastmilk Transfer in Infants of Lactating Women With Multiple Sclerosis Treated With Ocrelizumab: Primary Results of the Prospective Multicentre, Open-Label Phase IV Study SOPRANINO

Bove R, Oreja-Guevera C, Hellwig K, et al. Presented at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis Meeting; September 18 - 20, 2024. ECTRIMS Oral presentation #O039

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

Pregnancy and Infant Outcomes in Women Receiving OCR for the Treatment of Multiple Sclerosis: Analysis of the Largest Available Outcome Database

Hellwig K, Oreja-Guevara C, Vukusic S, et al. Presented at the 9th Joint European Committee for Treatment and Research in MS - Americas Committee for Treatment and Research in MS Meeting; October 11 - 13, 2023. ECTRIMS-ACTRIMS Poster P061

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.

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.

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OCREVUS / OCREVUS ZUNOVO

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    9-hole peg test

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    American Academy of Allergy Asthma & Immunology

  • AAN
    American Academy of Neurology

  • ABC
    activated B-cell–like subtype

  • AE
    Adverse event

  • Ang2
    Angiopoietin-2

  • ARR
    Annualized Relapse Rate

  • ART
    Assisted Reproductive Technology

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    American Society for Transplantation and Cellular Therapy

  • ATG
    Anti-thymocyte globulin

  • AUC
    area under the serum concentration–time curve

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    chronic active lesions

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    Chimeric antigen receptor

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    composite clinical disease progression

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    clinical cut-off date

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    confirmed disability accumulation

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    central nervous system

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    Diffuse large B-cell lymphoma

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    Disease-modifying therapy

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    Disease-modifying treatment

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    Duration of complete response

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    Double-blind, placebo-controlled food challenge

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    Eastern Cooperative Oncology Group performance status

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    European Committee for Treatment and Research in Multiple Sclerosis

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    Expanded Disability Status Scale

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    event-free survival for efficacy causes (time from randomization to the earliest occurrence of disease progression/relapse, death due to any cause, initiation of any non-protocol specified anti-lymphoma treatment, or biopsy-confirmed residual disease after treatment completion)

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    gadolinium-enhancing

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    glial fibrillary acidic protein

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    geometric mean ratio

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    immunoglobulin G

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    Immunoglobulin G1

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    injection reaction

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    Independent Review Committee

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    Immunoreceptor tyrosine-based inhibitory motif

  • ITT
    intention-to-treat

  • IV
    intravenous

  • LLN
    Lower limit of normal

  • LLOQ
    lower limit of quantification

  • LMP
    last menstrual cycle

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    Last menstrual period

  • MAS
    Macrophage activation syndrome

  • MBP
    myelin basic protein

  • MCA
    Major congenital anomalies

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    Medical Dictionary for Regulatory Activities

  • MHC
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  • min
    minutes

  • MRI
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  • MS
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    Memorial Sloan Kettering Cancer Center

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    Multiple Sclerosis Severity Scale

  • N/E
    new/enlarging

  • NfH
    neurofilament heavy chain

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    neurofilament light chain

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  • NO
    Nitric oxide

  • NOS
    Not otherwise specified

  • OB/Gyn
    Obstetrics and Gynecology

  • OCR
    ocrelizumab

  • OCR
    OCREVUS (ocrelizumab)

  • OCT
    optical coherence tomography

  • OR
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    overall survival

  • PD
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    Programmed cell death protein 1

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    Programmed death-ligand 1

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  • PK
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  • PMBCL
    Primary mediastinal B-cell lymphoma

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    progressive multifocal leukoencephalopathy

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    rituximab plus cyclophosphamide, doxorubicin, vincristine, prednisone

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    Reserve Against Disability in Early MS

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    rapid automatized naming

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    recombinant human hyaluronidase PH20

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    subcutaneous

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  • T
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    hour