Ocrelizumab Drug Label Updated With New Safety Information

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The FDA approved an updated drug label for the multiple sclerosis drug, including updates on immunizations and risks in specific patient populations.

The US FDA has approved updates to the drug label of ocrelizumab (Ocrevus; Roche/Genentech) reflecting new information about infusion reactions, vaccinations, and risks in specific patient populations.

The drug, which was approved in 2017 for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, as well as secondary progressive and primary progressive disease, is delivered via intravenous infusion every 6 months following a loading dose.

Several updates were made to the drug label under the Warnings and Precautions and Patient Counseling Information sections.

Anaphylaxis has been added to the list of possible infusion-related reactions. Under the Infections sub-section, information regarding the need for immunizations has been added. The drug label now advises that all immunizations should be administered according to immunization guidelines at least 4 weeks prior to initiating treatment with ocrelizumab for live or live-attenuated vaccines. When possible, non-live vaccines should be administered at least 2 weeks prior to treatment initiation. In addition, it also advises that infants of mothers who were exposed to ocrelizumab during pregnancy should not receive live or live-attenuated vaccines before confirming that B-cell counts have recovered as measured by CD19+ B-cells, as depletion of B-cells can increase the risks associated with these vaccines. The administration of non-live vaccines to infants can be done prior to B-cell recovery with the consideration of assessing vaccine immune response to assess whether a protective immune response was mounted.

The update also included the addition of a subsection under Drug Interactions, which detailed findings from a phase 3b open-label study examining the concomitant use of ocrelizumab and non-live vaccines. The findings suggest that concomitant use attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide, pneumococcal conjugate vaccines, and seasonal inactivated influenza vaccines; however, the impact on vaccine effectiveness is unknown.

The drug label update also features revisions to the pregnancy risk summary, which now points out that immunoglobulins are known to cross the placental barrier, which may be associated with B-cell depletion in infants born to mothers exposed to ocrelizumab. The duration and impact of that depletion in infants is unknown.

Updates to the Patient Counseling section include prompts for patients to inform their healthcare provider of any planned vaccinations prior to the start of treatment. It also requests that patients consult their healthcare provider prior to receiving any non-live vaccines, including the seasonal flu vaccine, while being treated with ocrelizumab. Finally, it prompts patients who are pregnant or planning on becoming pregnant to consult their physician regarding infant vaccinations, as some precautions may be necessary.

REFERENCE

Drug Safety-related Labeling Changes (SrLC). US FDA website. January 15, 2020. accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm. Accessed January 15, 2020.