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Ocrelizumab

    Brands

    DEA Class;  Rx

    Common Brand Names; Ocrevus

    •  Monoclonal Antibodies; 
    • Multiple Sclerosis Treatments

    CD20-directed cytolytic monoclonal antibody which targets B-cells
    Used in adults for primary progressive MS and relapsing forms of MS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease
    Infusion reactions are common; pre-medication is needed prior to infusion

    Indicated for the treatment of primary progressive or relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

    Active HBV infection

    History of life-threatening infusion reaction to ocrelizumab

    • Upper respiratory tract infections (40-49%)
    • Infusion-related reactions (34-40%)
    • Skin infections (14%)
    • Decreased neutrophil counts (13%)
    • Lower respiratory tract infections (8-10%)
    • Depression (8%)
    • Cough (7%)
    • Back pain (6%)
    • Herpes virus-associated infections (5-6%)
    • Diarrhea (6%)
    • Peripheral edema (6%)
    • Pain in extremity (5%)
    • Gastrointestinal disorders: Immune-mediated colitis
    • Infections and infestations: Serious herpes infections and progressive multifocal leukoencephalopathy

    Infusion reactions (eg, pruritus, rash, urticaria, erythema, bronchospasm, throat irritation, oropharyngeal pain, dyspnea, pharyngeal or laryngeal edema, flushing, hypotension, pyrexia, fatigue, headache, dizziness, nausea, tachycardia) may occur; monitor during treatment and at least 1 hr after treatment; inform patients that infusion reactions can occur up to 24 hours after infusion

    B-cell depleting therapy decreases immunoglobulin levels, which is associated with increased rates of serious infections; monitor levels of quantitative serum immunoglobulins during treatment and after discontinuing until B-cell repletion; consider discontinuing in patients with serious opportunistic or recurrent serious infection, and if prolonged hypogammaglobulinemia requires treatment with IVIG

    Increased risk of malignancy, including breast cancer exists; patients should follow standard breast cancer screening guidelines

    No data available to assess risk in pregnant women

    Unknown if distributed in human breast milk

    Adults

    600 mg/dose IV.

    Geriatric

    600 mg/dose IV.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Infants

    Not indicated.

    Ocrelizumab

    solution for injection

    • 30mg/mL (10mL single-dose vial)