Ublituximab: clinical use

Prescribing considerations

• Initiate and supervise through clinicians experienced in neurological disease, with facilities for managing serious infusion reactions.
• Assess active infection, immune status, hepatitis B status, vaccination requirements, malignancy history and pregnancy potential before treatment.
• Delay administration until an active infection has resolved.
• Record the product name and batch number for biological traceability.

Contraindications and cautions

• Hypersensitivity to ublituximab or an excipient
• Severe active infection
• Severely immunocompromised state
• Known active malignancy

Monitoring

• Observe for infusion reactions during administration and recognise that reactions can occur after leaving the unit.
• Monitor clinically for infection, hepatitis B reactivation and new or worsening neurological symptoms suggestive of PML.
• Assess immune status and relevant blood results; ublituximab can reduce immunoglobulins, lymphocytes and neutrophils.
• Review vaccine status before treatment and confirm B-cell recovery before live vaccination after treatment.
• Consider infant B-cell measurement before live vaccination following exposure during pregnancy.

Clinical pharmacology

Ublituximab is a chimeric IgG1 monoclonal antibody targeting CD20-expressing B cells. It produces B-cell lysis mainly through antibody-dependent cell-mediated cytotoxicity, with a smaller contribution from complement-dependent cytotoxicity. As a protein, it is expected to be cleared through catabolism into peptides and amino acids.

Formulation and product differences

• The product is a single-use concentrate requiring dilution in sodium chloride solution before intravenous administration.
• It is clear to opalescent and colourless to slightly yellow; it must not be shaken or frozen and should be protected from light.

Solution for infusion

Route: Intravenous

Strengths: 150 mg