Ocrevus (Ocrelizumab)

Generic Name

Ocrelizumab

Brand Names

Ocrevus, Ocrevus Zunovo

FDA approval date: March 28, 2017

Classification: CD20-directed Cytolytic Antibody

Form: Injection

What is Ocrevus (Ocrelizumab)?

OCREVUS is indicated for the treatment of: Relapsing forms of multiple sclerosis , to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults Primary progressive MS, in adults OCREVUS is a CD20-directed cytolytic antibody indicated for the treatment of: Relapsing forms of multiple sclerosis , to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults Primary progressive MS, in adults

Approved To Treat

Multiple Sclerosis (MS)

Top Global Experts

Save this treatment for later

Not sure about your diagnosis?

Check Your Symptoms

Related Clinical Trials

A Prospective, Multicenter, Single-arm Study of Ocrelizumab Administered Subcutaneously in Patients With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy

Enrollment Status: Recruiting

Publish Date: September 08, 2026

Intervention Type: Drug

Study Phase: Phase 4

Summary: The purpose of this study is to assess the imaging biomarkers, patient outcomes, safety, tolerability, and treatment satisfaction of ocrelizumab (OCR) combined with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) in participants with relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS) after switching from another anti-cluster of differenti...

A Randomized, Open-label, Parallel-group, Non-inferiority Study Comparing Efficacy, Safety, and Tolerability of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis, Followed by Open-label Treatment With Remibrutinib

Enrollment Status: Recruiting

Publish Date: August 26, 2026

Intervention Type: Drug

Study Phase: Phase 3

Summary: The purpose of this Phase 3b study is to assess the efficacy, safety and tolerability of remibrutinib after switching from ocrelizumab and compared to continuous ocrelizumab treatment, in patients living with relapsing multiple sclerosis (plwRMS).

Comparative Effectiveness of Kesimpta® (Ofatumumab) Versus Ocrevus® (Ocrelizumab) in Real-world Practice: A Retrospective Study

Enrollment Status: Recruiting

Publish Date: August 21, 2026

Summary: This study aims to generate real-world evidence on the clinical effectiveness and economic burden of ofatumumab (OMB) versus ocrelizumab (OCR) in patients diagnosed with multiple sclerosis (MS) in the United States (US). Clinical effectiveness will be assessed using annualized relapse rate (ARR), while economic burden will be assessed using healthcare resource utilization (HCRU) and healthcare cos...

View All Clinical Trials

Related Latest Advances

Pregnancy Exposure to Anti-CD20 Monoclonal Antibodies in Patients With Multiple Sclerosis: Results From an Italian Multicenter Registry Study.

Journal: Neurology(R) neuroimmunology & neuroinflammation

Published: August 28, 2026

FCGR3A Polymorphism Controls B-Cell Repopulation Kinetics in People With Multiple Sclerosis Treated With Ocrelizumab.

Journal: Neurology(R) neuroimmunology & neuroinflammation

Published: August 11, 2026

Natalizumab and Tyruko (natalizumab biosimilar) for treating highly active relapsing-remitting multiple sclerosis after at least one disease-modifying therapy: a systematic review and economic model.

Journal: Health technology assessment (Winchester, England)

Published: August 11, 2026

View All Latest Advances

Brand Information

OCREVUS (ocrelizumab)

1INDICATIONS AND USAGE

OCREVUS 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.

2DOSAGE FORMS AND STRENGTHS

Injection: 300 mg/10 mL (30 mg/mL) clear or slightly opalescent, and colorless to pale brown solution in a single-dose vial.

3CONTRAINDICATIONS

OCREVUS is contraindicated in patients with:

Active HBV infection
A history of life-threatening infusion reaction to OCREVUS

4ADVERSE REACTIONS

The following serious adverse reactions are discussed elsewhere in the labeling:

Infusion Reactions
Infections
Progressive Multifocal Leukoencephalopathy
Reduction in Immunoglobulins
Malignancies
Immune-Mediated Colitis
Liver Injury

4.1Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

4.2Postmarketing Experience

The following adverse reactions have been identified during postapproval use of OCREVUS. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

5DESCRIPTION

Ocrelizumab is a recombinant humanized monoclonal antibody directed against CD20-expressing B-cells. Ocrelizumab is a glycosylated immunoglobulin G1 (IgG1) with a molecular mass of approximately 145 kDa.

OCREVUS (ocrelizumab) injection for intravenous infusion is a preservative-free, sterile, clear or slightly opalescent, and colorless to pale brown solution supplied in single-dose vials. Each mL of solution contains 30 mg ocrelizumab, glacial acetic acid (0.25 mg), polysorbate 20 (0.2 mg), sodium acetate trihydrate (2.14 mg), and trehalose dihydrate (40 mg) at pH 5.3.

6HOW SUPPLIED/STORAGE AND HANDLING

OCREVUS (ocrelizumab) injection is a preservative-free, sterile, clear or slightly opalescent, and colorless to pale brown solution supplied as a carton containing one 300 mg/10 mL (30 mg/mL) single-dose vial (NDC 50242-150-01).

7PATIENT COUNSELING INFORMATION

Advise the patient and caregiver to read the FDA-approved patient labeling (Medication Guide).

8PRINCIPAL DISPLAY PANEL - 300 mg/10 mL Vial Carton

NDC 50242-150-01

Ocrevus

300 mg/10 mL

For Intravenous Infusion.

Single-Dose Vial.

Attention Pharmacist: Dispense the

Rx only

1 vial

Genentech

10233065

PRINCIPAL DISPLAY PANEL - 300 mg/10 mL Vial Carton