Drug Interaction Report

GENERALLY AVOID: The administration of live, attenuated virus or bacterial vaccines during immunosuppressant therapy with ocrelizumab may be associated with a risk of disseminated infection due to enhanced replication of vaccine virus or bacteria in the presence of diminished immune competence. Additionally, there is a lack of data on the safety of immunization following discontinuation of ocrelizumab. Ocrelizumab use causes a depletion of B-cells and can be expected to similarly increase the risk of a decreased or suboptimal immunologic vaccine response if immunization occurs before B-cells counts have recovered. Pharmacodynamic data has shown the median time to B-cell repletion following discontinuation of ocrelizumab is 72 weeks (range 27 to 175 weeks). For infants of mothers who have been exposed to ocrelizumab during pregnancy, there is a potential for depletion of B cells in their infants.

MANAGEMENT: Administration of live, attenuated vaccines should be avoided in patients receiving immunosuppressive therapy. Their use in patients who are severely immunocompromised is generally considered a contraindication. Live virus or bacterial vaccines should not be administered to patients during or after discontinuing ocrelizumab therapy until recovery from B-cell depletion occurs. Immunization status should be assessed prior to initiating ocrelizumab and recommended immunization with live or attenuated live vaccines should be completed at least 4 weeks prior to ocrelizumab initiation (some authorities have recommended at least 6 weeks). For infants of mothers exposed to ocrelizumab during pregnancy, live or live-attenuated vaccines should be delayed until B-cell levels have recovered; therefore, measuring CD19 positive B-cell levels prior to vaccination in these infants is recommended. Current local immunization guidelines and prescribing information for individual vaccines should be consulted for further information.