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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)
    Safety Topics Publications and Congresses
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    Safety Topics

    SECTIONS ON THIS PAGE

    Our Commitment
    General Safety
    Pregnancy and Lactation
    Serum lg Levels
    Infections
    PML
    COVID-19 and Vaccines
    Malignancies
    Fatalities
    Frequently Asked Questions
    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 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).

    Our Commitment to Safety Communication

    Safety updates from ongoing ocrelizumab clinical trials and post-marketing experience

    Data is drawn from the experience of patients who have started on ocrelizumab globally (as of March 2024): >350,000 patients (>1,000,000 patient-years), including >9,990 patients from clinical trials and open-label extension1.

    1. Data on file. Genentech. Accessed on Sep. 18, 2024.
    Report an adverse event icon

    Report an Adverse Event

    To report suspected adverse reactions, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    View global safety updates by topic and explore their associated publications, fact sheets, and post-marketing commitments below.

    The Prescribing Information is the primary source of information on the known and potential risks of ocrelizumab for relapsing forms of multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS).

    The select publications and congress posters/presentations provided below have been chosen to feature data related to the following topics of interest. These data are not an exhaustive list of published materials on this topic.

    General Safety

    View updates on safety data from the ocrelizumab clinical trials.

    Publications

    Safety of Ocrelizumab in Patients With Relapsing and Primary Progressive Multiple Sclerosis

    Hauser SL, Kappos L, Montalban X, et al. Neurology. 2021;97:e1546-e1559. Data-cut: January 2020.

    View Publication

    Congresses

    Safety of Ocrelizumab in Multiple Sclerosis: Up to 11 Years of Updated Analysis in Patients With Relapsing and Progressive Multiple Sclerosis

    Hauser SL, Kappos L, Montalban X, 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 #P300

    View ECTRIMS 2024 Poster

    Safety Of Ocrelizumab in Multiple Sclerosis: Updated Analysis in Patients With Relapsing and Primary Progressive Multiple Sclerosis

    Hauser SL, Kappos L, Montalban X, 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 P304

    View ECTRIMS 2023 Poster

    Safety of Ocrelizumab in Multiple Sclerosis: Long-Term Adverse Event Analyses Based on Initial Exposure Quartiles

    Hauser S, Bar-Or A, Weber M, et al. Presented at: 38th Congress of the European Committee for Treatment and Research in Multiple Sclerosis; October 26-28, 2022; Amsterdam, the Netherlands. Poster #eP1221.

    View ECTRIMS 2022 Poster

    Congresses

    MANUSCRIPT: Long-Term Surveillance of Ocrelizumab-Treated Patients With Multiple Sclerosis

    Wormser D, Butzkueven H, Hillert J, et al. Presented at: the European Academy of Neurology; June 29-July 2, 2019; Oslo, Norway.

    View EAN 2019 Poster

    Integration of Ocrelizumab Safety Data From the German Study CONFIDENCE Into the Global Post-Marketing Safety Studies MANUSCRIPT and VERISMO

    Ziemssen T, Berthold H, Dirks P, et al. Presented at: European Committee for Treatment and Research in Multiple Sclerosis; October 10–12, 2018; Berlin, Germany.

    View ECTRIMS 2018 Poster
    Looking for more information?

    Pregnancy and Lactation

    Roche Global Safety Database Analysis

    Family planning is an important consideration for many patients with MS. 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.

    Learn More

    Additional Resources

    Explore pregnancy and lactation data in patients treated with ocrelizumab. Check back soon for an updated fact sheet.

    View Fact Sheet

    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
    Looking for more information?

    Serum Immunoglobulin Levels

    Explore data on serum immunoglobulin (Ig) levels and infections in patients treated with ocrelizumab.

    View Fact Sheet
    Looking for more information?

    Infections

    Explore data on infections in patients treated with ocrelizumab.

    View Fact Sheet
    Looking for more information?

    PML

    View reports on cases of progressive multifocal leukoencephalopathy (PML) in patients treated with ocrelizumab.

    View Fact Sheet

    Congresses

    Cases Reported as Progressive Multifocal Leukoencephalopathy in Ocrelizumab-Treated Patients With Multiple Sclerosis

    Clifford DB, Gass A, Richert N, et al. Presented at: European Committee for Treatment and Research in Multiple Sclerosis. September 11-13, 2019, Stockholm, Sweden. Poster 970. Data-cut: July 2019.

    View ECTRIMS 2019 Poster
    Looking for more information?

    COVID-19 and Vaccines

    Explore data on COVID-19, including infections and vaccination, with ocrelizumab.

    View Fact Sheet

    Publications

    Understanding the Impacts of COVID-19 Pandemic in People With Multiple Sclerosis Treated With Ocrelizumab

    Pedotti R, Muros-Le Rouzic E, Raposo C, Schippling S, Jessop N. Mult Scler Relat Disord. 2021;55:103203. Publication data: October 2021.

    View Publication

    COVID-19 in Ocrelizumab-Treated People With Multiple Sclerosis

    Hughes R, Whitley L, Fitovski K, et al. Mult Scler Relat Disord. 2021;49:102725. Data-cut: July 2020.

    View Publication

    COVID-19 in Persons With Multiple Sclerosis Treated With Ocrelizumab - A Pharmacovigilance Case Series

    Hughes R, Pedotti R, Koendgen H. Mult Scler Relat Disord. 2020;42:102192. Data-cut: April 2020.

    View Publication

    Effect of Ocrelizumab on Vaccine Responses in Patients With Multiple Sclerosis: The VELOCE Study

    Bar-Or A, Calkwood JC, Chognot C, et al. Neurology. 2020;95(14):e1999-e2008. Data-cut: February 2017.

    View Publication

    Congresses

    COVID-19 in People With Multiple Sclerosis Treated With Ocrelizumab: Clinical Outcomes in Vaccinated Patients

    Hauser S, Gold R, Cutter G, et al. Presented at: 38th Congress of the European Committee for Treatment and Research in Multiple Sclerosis; October 26-28, 2022; Amsterdam, the Netherlands. Poster #EP1238.

    View ECTRIMS 2022 Poster

    SARS-CoV-2 Vaccination and COVID-19 Infections in People With Multiple Sclerosis Treated With Ocrelizumab in the Prospective, Multicentre, Noninterventional MuSicalE and CONFIDENCE Studies

    Trojano M, Meuth S, Buttmann M, et al. Presented at: 38th Congress of the European Committee for Treatment and Research in Multiple Sclerosis; October 26-28, 2022; Amsterdam, the Netherlands. Poster #P562.

    View ECTRIMS 2022 Poster

    SARS-CoV-2 Vaccine-Induced Immune Responses and Breakthrough Infections in People With Multiple Sclerosis Treated With Ocrelizumab

    Bar-Or A, Bhargava P, Patti F, et al. Presented at: 38th Congress of the European Committee for Treatment and Research in Multiple Sclerosis; October 26-28, 2022; Amsterdam, the Netherlands. Poster #P553.

    View ECTRIMS 2022 Poster
    Looking for more information?

    Malignancies

    Explore data on malignancies, including breast cancer, in patients treated with ocrelizumab.

    View Fact Sheet

    Congresses

    VERISMO: A Post-Marketing Safety Study to Determine the Incidence of All Malignancies and Breast Cancer in Patients With Multiple Sclerosis Treated With Ocrelizumab

    Wormser D, Evershed J, Ferreira G, et al. Presented at: American Academy of Neurology Annual Meeting; May 4–10, 2019; Philadelphia, PA, USA.

    View AAN 2019 Poster
    Looking for more information?

    Fatalities

    Explore data on fatalities among patients treated with ocrelizumab.

    View Fact Sheet
    Looking for more information?

    Frequently Asked Questions

    This section is not a comprehensive source of safety information on ocrelizumab. Due to the nature of post-marketing adverse event reports, information may be duplicated and/or incomplete. Some investigations remain ongoing, and therefore, information is subject to change. Additionally, the existence of an adverse event report does not establish causation. We evaluate these reports through our drug safety department, and attempt to verify the information to the extent possible. The Prescribing Information remains the primary source of information on the known and potential risks of ocrelizumab for RMS and PPMS.

    An adverse event is an untoward medical occurrence in a patient or participant in a clinical investigation, but does not necessarily have a causal relationship with an administered treatment. A post-marketing adverse event report is a report received by Genentech regarding an adverse event in a patient taking one of our marketed products.

    Robust global systems are in place to continuously monitor the safety of a drug, from the time it is first evaluated in clinical studies through commercialization. All adverse event reports are received by Genentech/Roche and due diligence is performed. The reports are then submitted to the FDA as per regulatory requirements.

    Yes; this website includes post-marketing adverse event reports received by Genentech/Roche. As part of our robust global pharmacovigilance process, these adverse event reports are reviewed, assessed, and due diligence is performed.

    The FAERS database generally includes post-marketing cases reported by the Market Authorization Holder. However, FAERS may also include reports from clinical trials based on the specific requirements set in FDA regulations along with reports that are submitted voluntarily to the FDA by other resources. As the FDA acknowledges, unverified information, as well as incomplete or duplicate cases, can be reported in the FAERS dashboard.

    Looking for more information?

    Reach out to a Genentech Medical Science Liaison near you, or connect with the contact center.

    Connect with an MSL
    Submit a Request

    Call Us: 1-800-821-8590 Hours: Monday-Friday, 5am-5pm PT

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    Publications icon

    Publications and Congresses

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

    Publications: The list of publications is not an exhaustive list of published materials on the product. The list of references by data topics is selected per evidence-based medicine criteria. To browse a full listing of published scientific literature:

    Visit PubMed

    Congresses: The list of congresses is a subset of Roche/Genentech posters and oral presentations for the product with data presented at scientific meetings in the recent 24 months. To browse full Roche/Genentech congress presentations and posters:

    Visit Medically

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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

    • Cmax
      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

    • EFSefficacy
      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