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 be diluted prior to administration ( , ) Monitor patients closely during
Hepatitis B virusand quantitative serum immunoglobulin screening are ... See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. ... refrigerator at 2°Cto 8°C(36°Fto 46°F) and 8 hours at room temperatureup to 25°C (77°F), which includes infusion time. In the event an intravenousinfusion cannot be completed the same day, discard ...
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