General Safety
Hauser SL, Kappos L, Montalban X, et al. Presented at: ECTRIMS 2021. October 13-15, 2021. Virtual. Poster 724.
Data-cut: November 2020.
COVID-19
Hauser SL, Gold R, Cutter G, et al. Presented at: ECTRIMS 2021. October 13-15, 2021. Virtual. Poster 933.
Data-cut: May 2021.
COVID-19
Pedotti R, Muros-Le Rouzic E, Raposo C, Schippling S, Jessop N. Mult Scler Relat Disord. 2021;55:103203.
Publication data: October 2021.
Pregnancy
Dobson R, Bove R, Boriello F, et al. Presented at: ECTRIMS 2021. October 13-15, 2021. Virtual. Poster 641.
Data-cut: March 2021.
General Safety
Hauser SL, Kappos L, Montalban X, et al. Neurology. 2021;97:e1546-e1559.
Data-cut: January 2020.
COVID-19
Hughes R, Whitley L, Fitovski K, et al. Mult Scler Relat Disord. 2021;49:102725.
Data-cut: July 2020.
Vaccines
Bar-Or A, Calkwood JC, Chognot C, et al. Neurology. 2020;95:e1999-e2008.
Data-cut: February 2017.
COVID-19
Hughes R, Pedotti R, Koendgen H. Mult Scler Relat Disord. 2020;42:102192.
Data-cut: April 2020.
PML
Clifford DB, Gass A, Richert N, et al. Presented at: ECTRIMS 2019. September 11-13, 2019. Stockholm, Sweden. Poster 970.
Data-cut: July 2019.
Update on ocrelizumab and PML.
Update on ocrelizumab and malignancies.
Update on ocrelizumab and serum Ig levels.
Update on ocrelizumab and pregnancy.
Update on ocrelizumab and fatalities.
Update on ocrelizumab and infections.
Update on ocrelizumab and COVID-19 pharmacovigilance data.
Post-marketing requirements and commitments for ocrelizumab can be accessed directly on the U.S. Food and Drug Administration website. The following information has also been presented, but may be subject to change based on any further discussions with regulatory authorities:
Wormser D, Butzkueven H, Hillert J, et al. Presented at the European Academy of Neurology in Oslo, Norway; June 29 –July 2, 2019.
Wormser D, Evershed J, Ferreira G, et al. Presented at the American Academy of Neurology Annual Meeting in Philadelphia, Pennsylvania; May 4–10, 2019.
Margulis AV, Andrews EB, Hernandez-Diaz S, et al. Presented at the American Academy of Neurology Annual Meeting in Los Angeles, California; April 21–27, 2018.
Ziemssen T, Berthold H, Dirks P, et al. Presented at the European Committee for Treatment and Research in Multiple Sclerosis in Berlin, Germany; October 10–12, 2018.
Wormser D, Engel P, Hahn K, et al. Presented at the American Academy of Neurology Annual Meeting in Los Angeles, California; April 21–27, 2018.
Prescribing Information
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).
*Due to the nature of post-marketing adverse event reports, some of the investigations remain ongoing and therefore may be subject to change. For more information, please see the FAQ.
Giovannoni G, et al. Pract Neurol. 2016;16:389–393.
Giovannoni G, et al. Pract Neurol. 2016;16:389–393.
Rothman KJ, et al, eds. Modern Epidemiology. 3rd ed. Lippincott Williams and Wilkins; 2008.
Rothman KJ, et al, eds. Modern Epidemiology. 3rd ed. Lippincott Williams and Wilkins; 2008.
New Jersey Department of Health and Senior Services. Fact Sheet: Explanation of Standardized Incidence Ratios. March 2010. Available at: https://www.state.nj.us/health/ceohs/documents/eohap/haz_sites/passaic/pompton_lakes/pompton_lakes_fs_sir.pdf.
New Jersey Department of Health and Senior Services. Fact Sheet: Explanation of Standardized Incidence Ratios. March 2010. Available at: https://www.state.nj.us/health/ceohs/documents/eohap/haz_sites/passaic/pompton_lakes/pompton_lakes_fs_sir.pdf.
Varallo FR, et al. Clin Ther. 2017;39:686–696.
Varallo FR, et al. Clin Ther. 2017;39:686–696.
Porta M, ed. A Dictionary of Epidemiology 6th ed. Oxford University Press; 2014. Accessed October 2021. http://irea.ir/files/site1/pages/dictionary.pdf
Porta M, ed. A Dictionary of Epidemiology 6th ed. Oxford University Press; 2014. Accessed October 2021. http://irea.ir/files/site1/pages/dictionary.pdf
European Medicines Agency. Human regulatory. Post-authorisation. Accessed October 2021. https://www.ema.europa.eu/en/human-regulatory/post-authorisation
European Medicines Agency. Human regulatory. Post-authorisation. Accessed October 2021. https://www.ema.europa.eu/en/human-regulatory/post-authorisation
US Food and Drug Administration. Postmarketing Requirements and Commitments: reports. Updated November 25, 2020. Accessed October 2021. https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/ucm064436.htm
US Food and Drug Administration. Postmarketing Requirements and Commitments: reports. Updated November 25, 2020. Accessed October 2021. https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/ucm064436.htm
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