Transcription of OCREVUS Prescribing Information - Genentech
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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 equivalent corticosteroid) and an antihistamine( , diphenhydramine)prior to each infusion ( ) AdministerOCREVUS by intravenous infusionoStart dose: 300 mg intravenous infusion, followed two weeks later by a second 300 mg intravenous infusion ( )oSubsequent doses: 600 mg intravenous infusionevery 6 months( ) Must b
OCREVUS® (ocrelizumab) injection, for intravenous use Initial U.S. Approval: 2017-----RECENT MAJOR CHANGES-----Dosage and Administration (2.1, 2.3) 12/2020 Warnings and Precautions(5.2, 5.3) 11/2020 ... and possibly other pre-medication to reduce the risk of infusion reactions prior to each infusion]was34to 40%,withthe highest incidence with ...
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