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

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Family Planning
Pregnancy and Infant Outcomes
Breastfeeding
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 ECTRIMS 2023.

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 2023 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 July 2023
  • Prospective: Final outcomes were unknown at initial notification (n=2,446)
  • Retrospective: Final outcomes were known at initial notification (n=868)

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=351)		 EXPOSED
(n=512)		 TOTALd
(n=1,145)		 GENERAL POPULATION
Live birthse 88.3% 84.2% 83.6% 70.2%18
Full term (≥37 weeks)f 70.9% 65.7% 61.4% -
Preterm (<37 weeks)f 8.4% 9.5% 8.5% 6.5-10.4%18-20
Unknown gestational agef 20.7% 24.8% 30.2% -
Live births with MCAf 1.3% 1.6% 1.3% 2.0-4.4%18-23
Ectopic pregnancye 0.9% 0.8% 1.2% 1.1-2.0%18,19
Elective terminatione 1.7% 7.4% 5.1% 18.2%18
Intrauterine fetal deathe
Spontaneous abortion, ≤22 weeks 9.1% 7.4% 10.0% 10-20%18,19
Stillbirth, >22 weeks - 0.2% <0.1% 0.2-0.7%18,20

The developmental risk associated with the use of Ocrevus in pregnant women has not been determined.14 Please consult the Ocrevus 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 [n=310], exposed in utero [n=431], total [n=957]).

Roche Global Safety Database Analysis: 1-Year Follow-Up Data in Infants Exposed to Ocrelizumab

Swipe to see the full table

Known Infant Outcomes With Follow-Up in the First Year of Life (n=226)13,g
  Not exposed in utero
(N=54)		 Exposed in utero
(N=127)		 Unknown exposure (N=45) Total
(N=226)
Live or live-attenuated vaccines administered, n(%)h Yes 14 (25.9%) 29 (22.8%) 7 (15.6%) 50 (22.1%)
No - - - -
Unknown 40 (74.1%) 98 (77.2%) 38 (84.4%) 176 (77.9%)
Infections reported, n (%) Yes 9 (16.7%)j 33 (26.0%)k 17 (37.8%)l 59 (26.1%)
No 21 (38.9%) 34 (26.8%) 17 (37.8%) 72 (31.9%)
Unknown 24 (44.4%) 60 (47.2%) 11 (24.4%) 95 (42.0%)
B-cell levels, n (%)i Normal 4 (7.4%) 39 (30.7%) 12 (26.7%) 55 (24.3%)
Abnormal - 6 (4.7%)m - 6 (26.5%)
Unknown 50 (92.6%) 82 (64.6%) 33 (73.3%) 165 (73.0%)

The developmental risk associated with use of Ocrevus in pregnant women has not been determined.14 Please consult the Ocrevus Prescribing Information

  1. Includes all known outcomes, either prospectively or retrospectively reported.
  2. As of July 2023, there have been no reports of breakthrough infections following administration of common childhood vaccines in infants born to mothers receiving ocrelizumab within 6 months prior to the LMP and/or during pregnancy, enrolled in WA40063 (OCREVUS pregnancy registry).
  3. Where actual B-cell levels were reported, adjudication on whether results were below the lower limit of normal was made according to Borriello et al, 2022.24
  4. Cold (n=1), COVID-19 (n=1), ear infection (n=1), hyperbilirubinemia (n=2), UTI (n=1), respiratory syncytial virus (n=1), vomiting and fever after 6-month vaccine (n=1), non-specified infection (n=1).
  5. Asphyxia (n=1), common cold (n=1), COVID-19 (n=3), COVID-19, influenza and hand-foot-mouth disease (n=1), hyperbilirubinemia and anemia (n=1), acidosis (n=1), Kawasaki disease (n=1), nasopharyngitis (n=1), non-specified infection (n=5), prematurity (n=1), respiratory distress (n=6), respiratory syncytial virus (n=5), sepsis (n=2), URTI (n=1), UTI and ear infection (n=1), volvulus (n=1), vomiting/swelling (n=1).
  6. Bradycardia (n=1), COVID-19 (n=1), COVID-19, enterococcus faecalis, staphylococcus and respiratory syncytial virus (n=1), eye infection (n=1), gastrointestinal infection and otitis (n=1), group B streptococcus (n=2), non-specified infection (n=3), oral candidiasis and UTI (n=1), oral candidiasis (n=1), nephritis (n=1), respiratory distress (n=1), sepsis and pneumonia (n=1), pneumonia (n=1), UTI (n=1).
  7. Lower B-cell levels at birth, not further specified (n=3); at 2 weeks, CD19 of 0 (n=1); at 17 days of age, B-cell levels were 85/ul (n=1); lower B-cell levels with timing and levels not specified (n=1).

References

  1. Hellwig K, et al. Pregnancy and infant outcomes. Poster presented at: ECTRIMS Annual Meeting; October 11-13, 2023; Milan, Italy.
  2. OCREVUS. Prescribing Information. Accessed May 24, 2023. 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.
  10. Centers for Disease Control and Prevention (CDC). MMWR Morb Mortal Wkly Rep. 2008;57(1):1-5.
  11. EMA Guideline on the exposure to medicinal products during pregnancy. Accessed November 28, 2023. https://www.ema.europa.eu/en/​documents/​regulatory-procedural-guideline/guideline-exposure-medicinal-products-during-pregnancy-need-post-authorisation-data_en.pdf.
  12. Borriello F, et al. J Allergy Clin Immunol. 2022;150(5):1216-1224.

Breastfeeding

Roche Global Safety Database Analysis: Cases of Infant Exposure to OCR Through Breastfeeding (n=126)13,a

Swipe to see the full table

  Vaccinations, n(%) Infections, n(%) Normal B-cell levelsb, n(%) Exposure in utero, n(%)
Yes 4.0% 8.7%c 5.6% 63.5%
No - 3.2% - 36.5%
Unknown 96.0% 88.1% 94.4% -

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Ocrevus and any potential adverse effects on the breastfed infant from Ocrevus or from the underlying maternal condition.14 Please consult the Ocrevus Prescribing Information.

  1. Includes all known outcomes, either prospectively or retrospectively reported.
  2. Percentages represent fractions of the total reports of potential infant OCR exposure through breastfeeding for the respective outcomes (vaccines administered, infections/adverse events reported, B-cell levels reported, also exposed in utero). Where actual B-cell levels were reported, adjudication on whether results were below the lower limit of normal was made according to Borriello et al, 2022.24
  3. Conjunctivitis and otitis media (n=1); eye infection (n=1); pelvic inflammation/nephritis (n=1); excessive vomiting/swelling due to potential dairy allergies (n=1); life-threatening breathing disorder and mild neurodermatitis (n=1); vomiting and fever after 6-month vaccine (n=1); unspecified neonatal infection (n=2); respiratory syncytial virus infection (n=2); upper respiratory tract infection (n=1).

References

  1. Hellwig K, et al. Pregnancy and infant outcomes. Poster presented at: ECTRIMS Annual Meeting; October 11-13, 2023; Milan, Italy.
  2. OCREVUS. Prescribing Information. Accessed November 29, 2023. https://www.gene.com/download/​pdf/​ocrevus_prescribing.pdf.
  1. Borriello F, et al. J Allergy Clin Immunol. 2022;150(5):1216-1224.

Resources

Explore additional resources related to this safety topic.

View Fact Sheet
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ECTRIMS 2023 Poster

See the full data from the Roche Global Safety Database presented at ECTRIMS 2023.

View on Medically

Congresses

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

View ECTRIMS 2023 Presentation

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

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
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TOP

  • AAAAI
    American Academy of Allergy Asthma & Immunology

  • AE
    Adverse event

  • Ang2
    Angiopoietin-2

  • ARR
    Annualized Relapse Rate

  • ART
    Assisted Reproductive Technology

  • ASTCT
    American Society for Transplantation and Cellular Therapy

  • ATG
    Anti-thymocyte globulin

  • CAR
    Chimeric antigen receptor

  • CD3
    Cluster of differentiation 3

  • CD4
    Cluster of differentiation 4

  • CD8
    Cluster of differentiation 8

  • CD19
    Cluster of differentiation 19

  • CD20
    Cluster of differentiation 20

  • CD226
    Cluster of differentiation 226

  • CDC
    Centers for Disease Control and Prevention

  • CI
    Confidence Interval

  • COVID-19
    Coronavirus disease of 2019

  • CPAP
    Continuous positive airway pressure

  • CR
    Complete response

  • CRP
    C-reactive protein

  • CRS
    Cytokine release syndrome

  • CT
    Computed tomography

  • CTCAE
    Common Terminology Criteria for Adverse Events

  • DIC
    Disseminated intravascular coagulation

  • DLBCL
    Diffuse large B-cell lymphoma

  • DMT
    Disease-modifying therapy

  • DMT
    Disease-modifying treatment

  • DoCR
    Duration of complete response

  • DoR
    Duration of response

  • DBPCFC
    Double-blind, placebo-controlled food challenge

  • ECOG PS
    Eastern Cooperative Oncology Group performance status

  • ECTRIMS
    European Committee for Treatment and Research in Multiple Sclerosis

  • EDSS
    Expanded Disability Status Scale

  • EMA
    European Medicines Association

  • FAERS
    FDA Adverse Event Reporting System

  • FDA
    Food and Drug Administration

  • FDA
    US Food and Drug Administration

  • FL
    Follicular lymphoma

  • HCP
    Health Care Provider

  • HGBCL
    High-grade B-cell lymphoma

  • HLH
    Hemophagocytic lymphohistiocytosis

  • ICANS
    Immune effector cell-associated neurotoxicity syndrome

  • ICU
    Intensive care unit

  • Ig
    Immunoglobulin

  • IgE
    Immunoglobulin E

  • IgG1
    Immunoglobulin G1

  • INR
    International normalized ratio

  • IRC
    Independent Review Committee

  • IRR
    Infusion-related reaction

  • ITIM
    Immunoreceptor tyrosine-based inhibitory motif

  • LLN
    Lower limit of normal

  • LMP
    last menstrual cycle

  • LMP
    Last menstrual period

  • MAS
    Macrophage activation syndrome

  • MCA
    Major congenital anomalies

  • MHC
    Major histocompatibility complex

  • MS
    Multiple sclerosis

  • MSKCC
    Memorial Sloan Kettering Cancer Center

  • NK
    Natural killer

  • NO
    Nitric oxide

  • NOS
    Not otherwise specified

  • OB/Gyn
    Obstetrics and Gynecology

  • OCR
    OCREVUS (ocrelizumab)

  • OR
    Odds ratio

  • ORR
    Objective response rate

  • PD-1
    Programmed cell death protein 1

  • PD-L1
    Programmed death-ligand 1

  • PET
    Positron emission tomography

  • PFS
    Progression-free survival

  • PMBCL
    Primary mediastinal B-cell lymphoma

  • PML
    progressive multifocal leukoencephalopathy

  • PPMS
    Primary progressive multiple sclerosis

  • PTT
    Partial thromboplastin time

  • PVR
    Poliovirus receptor

  • RID
    Relative infant dose

  • RMS
    Relapsing multiple sclerosis

  • RRMS
    Relapsing-remitting multiple sclerosis

  • SAE
    Serious adverse event

  • T
    Trimester

  • TCR
    T-cell receptor

  • TIGIT
    T cell immunoreceptor with Ig and ITIM domains

  • UCSF
    University of California San Francisco

  • USPI
    United States Prescribing Information

  • URTI
    Upper respiratory tract infection

  • UTI
    Urinary tract infection

  • VWF
    von Wilebrand factor

  • NIH
    National Institutes of Health