Ocrevus (Ocrelizumab)

What it is and what it treats

Ocrevus (ocrelizumab) is a humanised monoclonal antibody that selectively targets CD20-expressing B lymphocytes, a cell population implicated in the inflammatory and neurodegenerative processes underlying multiple sclerosis (MS).

It is approved for the treatment of relapsing forms of multiple sclerosis and, notably, for primary progressive multiple sclerosis (PPMS), a form of the disease for which few disease-modifying options exist. Regulatory approval for the PPMS indication was based on the ORATORIO trial, which described a reduction in confirmed disability progression relative to placebo.

In relapsing MS, Phase III trials comparing ocrelizumab with interferon beta-1a described reductions in annualised relapse rates and MRI lesion activity, supporting its role as a disease-modifying therapy for patients with active relapsing disease as determined by a treating neurologist.

Presentations and dosage forms

• Concentrate for solution for infusion, 300 mg per 10 mL vial
• Administered following dilution, by intravenous infusion only
• No subcutaneous, oral or self-administered presentation is authorised

How it is administered

The EU SmPC describes an initial dosing regimen of 300 mg administered by intravenous infusion, followed by a second 300 mg infusion two weeks later. Subsequent doses are described as 600 mg administered by intravenous infusion once every six months.

Each infusion is administered over an extended period with a defined starting rate that may be increased if tolerated, and premedication with a corticosteroid and an antihistamine is described in the label to reduce the frequency and severity of infusion-related reactions.

Administration takes place in a healthcare setting equipped to manage infusion reactions and with access to management of hypersensitivity. The label describes screening for hepatitis B and other relevant precautions prior to initiating treatment, along with ongoing clinical monitoring.

Storage and handling

• Store at 2–8 °C under continuous refrigeration; do not freeze
• Keep the vial in the outer carton to protect from light
• Do not shake the vial
• Diluted infusion solution should be used within the timeframe described in the SmPC
• Cold-chain integrity must be maintained throughout transport and storage

Side effects

The following reflects the adverse reaction profile described in the approved EU SmPC for ocrelizumab.

Commonly reported

Serious effects requiring medical attention

Patients should seek prompt medical attention for signs of infection, new neurological symptoms, or reactions during or after infusion; suspected adverse reactions should be reported through the relevant national pharmacovigilance scheme.

Ocrevus compared with other multiple sclerosis therapies

Ocrevus is distinguished from other B-cell-depleting or immune-modulating MS therapies, such as ofatumumab (a self-administered subcutaneous anti-CD20 antibody dosed monthly) and natalizumab (an alpha-4 integrin inhibitor dosed every four weeks), by its twice-yearly intravenous infusion schedule and its additional approval for primary progressive disease.

Selection among disease-modifying therapies for MS depends on disease subtype, activity, prior treatment history and individual risk factors, and should be made by a neurologist experienced in MS management rather than by direct comparison of dosing convenience alone.

Availability and supply route

Marketing authorisation status for Ocrevus varies by country, and approved indications, dosing schedules and pack presentations may differ between the EU, US and other regulated markets. Institutions should confirm local registration status before planning treatment.

Where local registration or supply is limited, named-patient or specials import frameworks exist in many jurisdictions to permit supply of a foreign-registered medicine against a valid prescription and appropriate regulatory documentation, under the responsibility of the treating physician.

Pharmacy Remedy is a licensed Turkish pharmaceutical wholesaler that supplies medicines through licensed distribution channels to hospitals, pharmacies and other authorised institutions; it does not sell medicines directly to the public and all supply is conditional on valid prescriptions and applicable import documentation.

Frequently asked questions

Primary sources

• EMA EPAR — Ocrevus
• FDA prescribing information — Ocrevus

Further reading and regulatory routes

• Which country Ocrevus is sourced from, and why prices differ
• How to verify a medicine is genuine
• Why medicines cost less in Türkiye
• WHO falsified medicine alerts
• Named patient supply
• UAE import guide
• For healthcare professionals
• All medicine monographs

Related medicines

• Ilaris (canakinumab)
• Keytruda (pembrolizumab)
• Opdivo (nivolumab)