Our Commitment to Safety Communication
Verified safety updates from ongoing ocrelizumab clinical trials and post-marketing experience
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).
As of December 2020, more than 200,000 patients with RMS and PPMS have started ocrelizumab globally, amounting to a total of more than 300,000 patient-years.1
The following ocrelizumab global safety updates are available. Click below to learn more:
Updated Safety Analysis
Additional Topics of Interest
Post-marketing Commitments
Indication:
Ocrelizumab is indicated for the treatment of:
- Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults
- Primary progressive MS, in adults
Report an Adverse Event:
Phone: (888) 835-2555
Hours: 24 hrs/day, 7 days/week
Medical Communications:
Submit a question online
Phone: (800) 821-8590
Hours: Monday - Friday, 5am - 5pm PT
Contact an MSL:
Request follow-up with a Genentech medical science liaison (MSL)
-
-
Genentech data on file: December 31, 2020, post-marketing experience; March 27, 2020, clinical trials data cut-off
Genentech data on file: December 31, 2020, post-marketing experience; March 27, 2020, clinical trials data cut-off
-
Rothman KJ, Greenland S, Lash TL. Modern Epidemiology. 3rd ed. Philadelphia, PA: Lippincott Williams and Wilkins; 2008. Available at: https://sgp1.digitaloceanspaces.com/proletarian-library/books/246ede0435010d90ce710415b214f21b.pdf
Rothman KJ, Greenland S, Lash TL. Modern Epidemiology. 3rd ed. Philadelphia, PA: Lippincott Williams and Wilkins; 2008. Available at: https://sgp1.digitaloceanspaces.com/proletarian-library/books/246ede0435010d90ce710415b214f21b.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.
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.
-
US Food and Drug Administration. Postmarketing Requirements and Commitments: Reports. https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/ucm064436.htm. Accessed January 2018
US Food and Drug Administration. Postmarketing Requirements and Commitments: Reports. https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/ucm064436.htm. Accessed January 2018
-
Giovannoni G, et al. Pract Neurol. 2016; 16:389–393.Giovannoni G, et al. Pract Neurol. 2016; 16:389–393.
-
Varallo FR, et al. Clin Ther. 2017;39:686–96.
Varallo FR, et al. Clin Ther. 2017;39:686–96.
-
-