OCREVUS

What it is

Ocrevus is a recombinant humanised anti-CD20 monoclonal antibody (IgG1 subtype). The intravenous formulation is supplied as a concentrate solution for infusion containing 30 mg/mL ocrelizumab, with each vial containing 300 mg of ocrelizumab in 10 mL. The subcutaneous formulation is supplied as a solution for injection containing 40 mg/mL ocrelizumab, with each vial containing 920 mg ocrelizumab in 23 mL.

Approved indications

— Relapsing forms of multiple sclerosis (RMS) to delay the progression of physical disability and to reduce the frequency of relapse. — Primary progressive multiple sclerosis (PPMS) to delay the progression of physical disability.

Dosing overview

Ocrevus IV is administered by intravenous infusion as a 600 mg dose every 6 months. The initial 600 mg dose is administered as two separate intravenous infusions of 300 mg each, separated by two weeks. Subsequent doses are administered as a single 600 mg intravenous infusion every 6 months, with a minimum interval of 5 months maintained between each dose. Patients may start Ocrevus treatment using either the intravenous or subcutaneous formulation, and patients currently receiving Ocrevus IV may switch to Ocrevus SC.

Key safety warnings

Premedication with 100 mg intravenous methylprednisolone (or an equivalent) approximately 30 minutes prior to each Ocrevus infusion and with an antihistaminic drug approximately 30–60 minutes before each infusion is recommended to reduce the frequency and severity of infusion-related reactions. Patients should be observed for at least one hour after the completion of the infusion. Ocrevus IV is administered through a dedicated line under the close supervision of an experienced healthcare professional with access to appropriate medical support to manage severe reactions such as serious infusion-related reactions.

PBS listing

The subcutaneous formulation 920 mg in 23 mL is listed on the PBS with 2 items, streamlined restriction, and an ex-manufacturer price of A$16,656.36. The intravenous concentrate solution 300 mg in 10 mL is listed on the PBS with 2 items, streamlined restriction, and an ex-manufacturer price of A$8,328.18.

Regulatory history

The intravenous formulation (ARTG 275778) was first listed on 13 July 2017. The TGA approved Ocrevus on 3 July 2017. In July and November 2017, the PBAC recommended Ocrevus for the treatment of relapsing-remitting multiple sclerosis and primary progressive multiple sclerosis in adult patients. In July 2025, the PBAC recommended the new subcutaneous formulation for relapsing-remitting multiple sclerosis under the same conditions as the intravenous form. The subcutaneous formulation (ARTG 446150) was first listed on 27 March 2025.