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)?

Living with multiple sclerosis (MS) can be unpredictable and exhausting, from fatigue and muscle weakness to sudden changes in mobility or vision. Modern medicine, however, continues to bring new hope. One such advancement is Ocrelizumab (brand name: Ocrevus), a prescription medication designed to slow down the progression of MS and help patients maintain independence and quality of life.

Ocrelizumab is a monoclonal antibody therapy that targets specific immune cells involved in damaging the nervous system. Approved by the U.S. Food and Drug Administration (FDA) in 2017, it is considered one of the first therapies effective for both relapsing forms of MS (RMS) and primary progressive MS (PPMS) making it a significant milestone in MS care.

What does Ocrelizumab do?

Ocrelizumab is prescribed for adults with:

  • Relapsing forms of multiple sclerosis (RMS), including relapsing-remitting disease and active secondary progressive disease.

  • Primary progressive multiple sclerosis (PPMS), a form that causes gradual worsening of symptoms without distinct relapses.

For many patients, Ocrelizumab helps:

  • Reduce relapse frequency in relapsing MS.

  • Slow disability progression in both relapsing and primary progressive forms.

  • Decrease MRI-detected brain lesions, which are markers of nerve damage.

Clinical studies have shown that patients taking Ocrelizumab experienced fewer relapses and less disability progression compared to those treated with interferon-based medications (Hauser et al., 2017). These improvements often translate to a better quality of life and longer periods of functional stability.

How does Ocrelizumab work?

Ocrelizumab works by targeting CD20-positive B cells, a specific type of immune cell that plays a role in attacking the myelin sheath (the protective covering of nerves) in people with MS. By binding to these cells, Ocrelizumab reduces abnormal immune activity while preserving the rest of the immune system’s ability to fight infections.

In simpler terms, this treatment “calms down” the immune system just enough to prevent it from damaging the brain and spinal cord without shutting it down completely.

Clinically, this mechanism helps:

  • Reduce new inflammatory lesions in the nervous system.
  • Protect nerve fibers from further degeneration.
  • Potentially delay long-term physical disability.

This targeted approach distinguishes Ocrelizumab from older MS treatments that act broadly on the immune system, leading to more side effects or reduced immunity.

Ocrelizumab side effects

Like all medications, Ocrelizumab can cause side effects, though many are manageable under medical supervision.

Common side effects include:

  • Infusion-related reactions (itching, rash, throat irritation, flushing or low blood pressure during or after infusion)
  • Fatigue
  • Upper respiratory tract infections
  • Headache

Less common but potentially serious side effects:

  • Increased risk of infections, including herpes or respiratory infections
  • Reactivation of hepatitis B virus (in patients with prior infection)
  • Rare cases of progressive multifocal leukoencephalopathy (PML), a severe brain infection

Who should avoid or use caution:

  • People with active infections should postpone treatment until fully recovered.
  • Those with a history of hepatitis B require screening and close monitoring.
  • Patients with weakened immune systems should discuss risks thoroughly with their healthcare provider.

Seek immediate medical attention if you have trouble breathing, severe rash, chest pain or signs of an allergic reaction during infusion.

While these risks sound concerning, most patients tolerate Ocrelizumab well when infusion safety protocols and monitoring guidelines are followed.

Ocrelizumab dosage

Ocrelizumab is administered as an intravenous (IV) infusion by a healthcare professional. The first dose is split into two infusions two weeks apart, followed by one infusion every six months.

Before each infusion, patients are often given medications like antihistamines or corticosteroids to minimize infusion-related reactions.

Monitoring during treatment typically includes:

  • Regular blood tests to check immune cell levels and liver function.
  • MRI scans to track disease activity and lesion development.
  • Screening for infections such as hepatitis B prior to starting therapy.

Special attention is given to older adults and those with weakened immunity, as they may be more susceptible to infections. Consistent follow-up helps ensure that the benefits of Ocrelizumab outweigh potential risks.

Does Ocrelizumab have a generic version?

As of now, no generic version of Ocrelizumab is available. It is marketed exclusively under the brand name Ocrevus by Genentech (a subsidiary of Roche).

While biosimilar versions may eventually become available, they must first undergo FDA evaluation to confirm they match the original in safety, purity, and potency.

Patients should be aware that FDA-approved biosimilars, once released, will be just as effective and safe as the brand-name drug but typically more affordable.

Conclusion

Ocrelizumab represents a major advancement in the treatment of multiple sclerosis—offering hope to those living with both relapsing and progressive forms of the disease. By selectively targeting harmful immune cells, it helps slow disease progression and protect neurological function.

While side effects and infusion reactions can occur, the overall safety and efficacy profile of Ocrelizumab make it a trusted option under the care of a qualified neurologist.

Every patient’s experience with MS and its treatment is unique. Staying informed, attending regular checkups, and discussing any new symptoms with your doctor can help you get the most out of your therapy.

Ocrelizumab is most effective when prescribed, monitored and supported by an experienced healthcare team, empowering patients to live with greater stability, control and confidence.

References

  1. Hauser, S. L., et al. (2017). Ocrelizumab in relapsing multiple sclerosis. New England Journal of Medicine, 376(3), 221–234. https://www.nejm.org/
  2. U.S. Food and Drug Administration (FDA). (2017). FDA approves new drug to treat multiple sclerosis. https://www.fda.gov/
  3. Mayo Clinic. (2024). Ocrelizumab (Intravenous Route) Description and Precautions. https://www.mayoclinic.org/

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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
    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 in greater detail in other sections of 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.
    The safety of OCREVUS has been evaluated in 1311 patients across MS clinical studies, which included 825 patients in active-controlled clinical trials in patients with relapsing forms of MS (RMS) and 486 patients in a placebo-controlled study in patients with primary progressive MS (PPMS).
    4.2Immunogenicity
    As with all therapeutic proteins, there is potential for immunogenicity. Immunogenicity data are highly dependent on the sensitivity and specificity of the test methods used. Additionally, the observed incidence of a positive result in a test method may be influenced by several factors, including sample handling, timing of sample collection, drug interference, concomitant medication, and the underlying disease. Therefore, comparison of the incidence of antibodies to OCREVUS with the incidence of antibodies to other products may be misleading.
    Patients in MS trials (Study 1, Study 2, and Study 3) were tested at multiple time points (baseline and every 6 months post-treatment for the duration of the trial) for anti-drug antibodies (ADAs). Out of 1311 patients treated with OCREVUS, 12 (~1%) tested positive for ADAs, of which 2 patients tested positive for neutralizing antibodies. These data are not adequate to assess the impact of ADAs on the safety and efficacy of OCREVUS.
    4.3Postmarketing 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 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
    Ocrevus has been selected.