The Food and Drug Administration (FDA) has approved updated labeling for Ocrevus (ocrelizumab; Genentech) to include new information on the timing of vaccine administration in patients planning to initiate treatment.

Ocrevus is indicated for the treatment of adult patients with relapsing or primary progressive forms of multiple sclerosis. Because vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation until B-cell repletion, immunizations should be administered ≥4 weeks prior to initiation of Ocrevus for live or live-attenuated vaccines and, whenever possible, ≥2 weeks prior to initiation for non-live vaccines. Previously, the labeling stated that immunizations should be administered ≥6 weeks prior to initiating treatment.

According to a Phase 3b open-label study, Ocrevus may interfere with the effectiveness of non-live vaccines. Among the MS patients included in the study, 68 were undergoing treatment with Ocrevus at the time of vaccination, while 34 were not receiving treatment. Results showed that concomitant exposure to Ocrevus was found to attenuate antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide, pneumococcal conjugate vaccines, and seasonal inactivated influenza vaccines. However, the impact of the attenuation on vaccine effectiveness remains unknown.

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A new section has also been included under the Warnings and Precautions section of the labeling regarding the vaccination of infants born to mothers treated with Ocrevus during pregnancy. In these infants, live or live-attenuated vaccines should not be administered before confirming the recovery of B-cell counts as measured by CD19+ B-cells; depletion of B-cells may increase the risks from live or live-attenuated vaccines. Non-live vaccines may be administered prior to recovery from B-cell depletion, however vaccine immune response assessment should be considered to see if a protective immune response has been mounted.

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