Ocrelizumab Updated Safety Analysis

Ongoing safety evaluations from clinical trials and the associated open-label extension, as well as information from the post-marketing experience (e.g., infusion reactions, infections, malignancies, progressive multifocal leukoencephalopathy, and fatalities)

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 American Academy of Neurology Annual Meeting in Los Angeles, California; April 21-27, 2018.

 

Additional Information on Topics of Interest*

Progressive Multifocal Leukoencephalopathy (PML)

Update on ocrelizumab and PML.

Fatalities

Update on ocrelizumab and fatalities.

 

Post-marketing Requirements and Commitments

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:

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 the American Academy of Neurology Annual Meeting in Los Angeles, California; April 21-27, 2018.

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 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.