OCREVUS Prescribing Information - Genentech

HIGHLIGHTS OF Prescribing INFORMATIONT hese highlights do not include all the Information needed to use OCREVUS safely and effectively. See full Prescribing Information for (ocrelizumab) injection, for intravenous useInitial Approval: 2017---------------------------RECENT MAJOR CHANGES---------------------------Dosage and Administration ( , ) 12/2020 Warnings and Precautions( , )11/2020---------------------------INDIC ATIONS AND USAGE---------------------------- OCREVUS is aCD20-directed cytolytic antibody 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(1) Primary progressive MS, in adults(1)-----------------------DOSAGE AND ADMINISTRATION----------------------- Hepatitis B virusand quantitative serum immunoglobulin screening are required before the first dose ( ) Pre-medicate with methylprednisolone (or an equiv)

and an antihistamine(e.g., diphenhydramine)prior to each infusion (2.2) AdministerOCREVUS by intravenous infusion o Start dose:300 mg intravenous infusion, followed two weeks later by a second 300 mg intravenous infusion (2.3) o Subsequent doses: 600mg intravenous infusionevery 6 months(2.3) Must be diluted prior to administration (2.3, 2.6)

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