Updated safety analysis

                      
                      

General Safety

Safety of ocrelizumab in multiple sclerosis: Up to 11 years of updated analysis in patients with relapsing and progressive multiple sclerosis
Data-cut: November 2023
                      
                      

Infections

Long-term analysis of infections and associated risk factors in patients with multiple sclerosis treated with ocrelizumab: Pooled analysis of 13 interventional clinical trials
Data-cut: November 2022
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Pregnancy

Pregnancy and infant outcomes in women with multiple sclerosis receiving ocrelizumab: Analysis of approximately 4,000 pregnancies to date
Data-cut: March 2024
                      
                      

Pregnancy

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
Data-cut: April 2024
                      
                      

Lactation

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
Data-cut: March 2024
                      
                      

IRRs

Infusion-related reactions with ocrelizumab in relapsing multiple sclerosis: Over 9 years of data from OPERA OLE
Data-cut: November 2021
                      
                      

Pregnancy

Ocrelizumab during pregnancy and lactation: Rationale and design of the MINORE and SOPRANINO studies in women with MS and their infants
Publication date: August 2022
                      


General Safety

Safety of ocrelizumab in patients with relapsing and primary progressive multiple sclerosis
Data-cut: January 2020
                      
                      

COVID-19

Understanding the impacts of COVID-19 pandemic in people with multiple sclerosis treated with ocrelizumab
Publication date: October 2021
                      
                      

COVID-19

COVID-19 in ocrelizumab-treated people with multiple sclerosis
Data-cut: July 2020
                      
                      

Vaccines

Effect of ocrelizumab on vaccine responses in patients with multiple sclerosis: The VELOCE study
Data-cut: February 2017
                      
                      

COVID-19

COVID-19 in persons with multiple sclerosis treated with ocrelizumab - A pharmacovigilance case series
Data-cut: April 2020

Abbreviations

COVID-19, coronavirus disease 2019; ECTRIMS, European Committee for Treatment and Research in MS; IRR, infusion-related reaction; OLE, open-label extension.

Prescribing information

Indications vary in different countries. The local prescribing information from your country is the primary source of information on the known and potential risks associated with ocrelizumab.
Archived data reports for fatalities were last updated February 2021. Please note that there will be no further updates of these archived materials
M-XX-00019243 (Date of preparation: December 2024)