Ocrelizumab

What it is and how it works

Mechanism of Action The precise mechanism by which ocrelizumab exerts its therapeutic effects in multiple sclerosis is unknown, but is presumed to involve binding to CD20, a cell surface antigen present on pre-B and mature B lymphocytes. Following cell surface binding to B lymphocytes, ocrelizumab results in antibody-dependent cellular cytolysis and complement-mediated lysis.

Mechanism class: CD20-directed Antibody Interactions

Indications

is 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 Primary progressive MS, in adults Relapsing-remitting MS, in pediatric patients 10 years of age and older who weigh 25 kg or more. OCREVUS is a CD20-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 Primary progressive MS, in adults Relapsing-remitting MS, in pediatric patients 10 years of age and older who weigh 25 kg or more

Dosage and administration (summary)

Before initiating OCREVUS, screen for Hepatitis B virus and obtain serum quantitative immunoglobulins, aminotransferases, alkaline phosphatase, and bilirubin Pre-medicate with methylprednisolone (or an equivalent corticosteroid) and an antihistamine (e.g., diphenhydramine) prior to each infusion Administer OCREVUS by intravenous infusion Adults and pediatric patients (10 years of age and older), who weigh 35 kg or more: Start dose: 300 mg intravenous infusion, followed two weeks later by a second 300 mg intravenous infusion Subsequent doses: 600 mg intravenous infusion every 6 months Pediatric patients (10 years of age and older) who weigh 25 kg to less than 35 kg: Start dose: 150 mg intrave…

Contraindications

is contraindicated in patients with: Active HBV infection A history of life-threatening infusion reaction to OCREVUS Active hepatitis B virus infection History of life-threatening infusion reaction to OCREVUS

Warnings and precautions

Infusion Reactions: Management recommendations for infusion reactions depend on the type and severity of the reaction. Permanently discontinue OCREVUS if a life-threatening or disabling infusion reaction occurs ( 2.3 , 5.1 ) Infections: Serious, including life-threatening and fatal infections, have occurred. Delay OCREVUS administration in patients with an active infection until the infection is resolved.

Pregnancy

Pregnancy Risk Summary OCREVUS is a humanized monoclonal antibody of an immunoglobulin G1 subtype and immunoglobulins are known to cross the placental barrier. There are no adequate data on the developmental risk associated with use of OCREVUS in pregnant women.

Storage and supply

Store OCREVUS vials at 2°C to 8°C (36°F to 46°F) in the outer carton to protect from light. Do not freeze or shake.

Source: Ocrelizumab (Ocrevus) — US FDA prescribing information, 2026-05-14, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.