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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

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.

Explore the Data

Family Planning

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

Women are 3 times more likely than men to have MS^1-4

~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 diagnosis^2,4

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

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

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General recommendations are to discontinue DMTs temporarily prior to conception^3-8

Man, woman, and child icon

Certain DMTs are associated with an increased risk of rebound upon cessation^3,5,6,9,10

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Recommended washout periods for DMTs should be considered to mitigate the risks of fetal exposure, especially in the case of DMTs with teratogenic potential^8,11,12

References

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

Exposure classification is based on OCR t_1/2=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 gestation^13,14.

Roche Global Safety Database Analysis: Pregnancy Outcomes by Exposure^13,b,c

Swipe to see the full table

	Prospective Cases With Known Outcomes
	NON-EXPOSED (n=454)	EXPOSED (n=655)	TOTAL^d (n=1,502)	GENERAL POPULATION
Live births^e	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 age^f	19.5%	24.9%	30.7%	-
Live births with MCA^f	1.5%	1.8%	1.3%	2.7-4.0%^18,20
Ectopic pregnancy^e	0.7%	0.6%	0.9%	1.1-2.0%^18,19
Elective termination^e	1.8%	6.3%	4.7%	18.2%¹⁸
Intrauterine fetal death^e
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.

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

References

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.
Ocrevus. Prescribing Information. Accessed Feb 10, 2025. https://www.gene.com/download/pdf/ocrevus_prescribing.pdf.
Gibiansky E, et al. Br J Clin Pharmacol. 2021;87(6):2511-2520.
Palmeira P, et al. Clin Dev Immunol. 2012;2012:985646.
Simister NE. Vaccine. 2003;21(24):3365-3369.
Anderson et al. EJN. 2022;30(1):162-171.
Khan E, et al. J Neuroimmunol. 2023;383:578178.
MacDonald SC, et al. Am J Epidemiol. 2019;188(1):57-66.
Lopez-Leon S, et al. J Neurol. 2020;267(9):2721-2731.

Resources

Explore additional resources related to this safety topic.

View Fact Sheet

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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.

View Publication

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.

View ECTRIMS 2024 Poster

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

View ECTRIMS 2024 Poster

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

View ECTRIMS 2024 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

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

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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9HPT
9-hole peg test
AAAAI
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
ASTCT
American Society for Transplantation and Cellular Therapy
ATG
Anti-thymocyte globulin
AUC
area under the serum concentration–time curve
CALs
chronic active lesions
CAR
Chimeric antigen receptor
cCDP
composite clinical disease progression
CCOD
clinical cut-off date
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
CDA
confirmed disability accumulation
CDC
Centers for Disease Control and Prevention
CDP
clinical disease progression
CI
Confidence Interval
CIS
clinically isolated syndrome
C_max
maximum serum concentration
COVID-19
Coronavirus disease of 2019
CNS
central nervous system
CPAP
Continuous positive airway pressure
CR
Complete response
CRP
C-reactive protein
CRS
Cytokine release syndrome
CSF
cerebrospinal fluid
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
EFS_efficacy
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)
EMA
European Medicines Association
EOT
end of treatment
EPIC
expression/genomics, proteomics, imaging, and clinical
FAERS
FDA Adverse Event Reporting System
FDA
Food and Drug Administration
FDA
US Food and Drug Administration
FL
Follicular lymphoma
GCB
germinal-center B-cell–like subtype
Gd
gadolinium-enhanced
Gd+
gadolinium-enhancing
GFAP
glial fibrillary acidic protein
GMR
geometric mean ratio
HCP
Health Care Provider
HGBCL
High-grade B-cell lymphoma
HGBL
high-grade B-cell lymphoma
HHV8
human herpesvirus 8
HLA
human leukocyte antigen
HLH
Hemophagocytic lymphohistiocytosis
HR
hazard ratio
ICANS
Immune effector cell-associated neurotoxicity syndrome
ICU
Intensive care unit
Ig
Immunoglobulin
IgE
Immunoglobulin E
IgG
immunoglobulin G
IgG1
Immunoglobulin G1
INR
International normalized ratio
IPI
International Prognostic Index
IR
injection reaction
IRC
Independent Review Committee
IRR
Infusion-related reaction
ITIM
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
LMP
Last menstrual period
MAS
Macrophage activation syndrome
MBP
myelin basic protein
MCA
Major congenital anomalies
MedDRA
Medical Dictionary for Regulatory Activities
MHC
Major histocompatibility complex
min
minutes
MRI
magnetic resonance imaging
MS
Multiple sclerosis
MSFC
Multiple Sclerosis Functional Composite
MSKCC
Memorial Sloan Kettering Cancer Center
MSSS
Multiple Sclerosis Severity Scale
N/E
new/enlarging
NfH
neurofilament heavy chain
NfL
neurofilament light chain
NK
Natural killer
NO
Nitric oxide
NOS
Not otherwise specified
OB/Gyn
Obstetrics and Gynecology
OCR
ocrelizumab
OCR
OCREVUS (ocrelizumab)
OCT
optical coherence tomography
OR
Odds ratio
ORR
Objective response rate
OS
overall survival
PD
pharmacodynamic
PD-1
Programmed cell death protein 1
PD-L1
Programmed death-ligand 1
PET
Positron emission tomography
PDR
protocol-defined relapse
PFS
Progression-free survival
PIRA
progression independent of relapse activity
PK
pharmacokinetics
PMBCL
Primary mediastinal B-cell lymphoma
PML
progressive multifocal leukoencephalopathy
Pola-R-CHP
polatuzumab plus rituximab, cyclophosphamide, doxorubicin, prednisone
PPMS
Primary progressive multiple sclerosis
PRLs
paramagnetic rim lesions
PRO
patient reported outcome
PTT
Partial thromboplastin time
PVR
Poliovirus receptor
R-CHOP
rituximab plus cyclophosphamide, doxorubicin, vincristine, prednisone
R-CHP
rituximab plus cyclophosphamide, doxorubicin, prednisone
RADIEMS
Reserve Against Disability in Early MS
RAN
rapid automatized naming
RAW
relapse-associated worsening
rHuPH20
recombinant human hyaluronidase PH20
RID
Relative infant dose
RMS
relapsing forms of multiple sclerosis
RMS
Relapsing multiple sclerosis
RRMS
Relapsing-remitting multiple sclerosis
SAE
Serious adverse event
SC
subcutaneous
SELs
slowly expanding lesions
SPMS
secondary progressive multiple sclerosis
T
Trimester
T25FW
Timed 25-Foot Walk
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
h
hour