rituximab: clinical use

Prescribing considerations

• Use under experienced supervision where full resuscitation facilities are available.
• Exclude active severe infection and assess recurrent infection, immunodeficiency and cardiovascular history.
• Screen every patient for hepatitis B; seek liver-specialist input for positive serology.
• Check immunoglobulins, blood counts and vaccination status before treatment.
• Review tumour burden and tumour-lysis risk in haematological malignancy.
• Record the administered brand and batch number for biological traceability.
• Provide relevant patient alert information for autoimmune indications.

Contraindications and cautions

• Hypersensitivity to rituximab, murine proteins or formulation excipients
• For the subcutaneous product, hypersensitivity to hyaluronidase
• Active severe infection
• Severely immunocompromised state
• For licensed autoimmune uses, severe heart failure or severe uncontrolled cardiac disease

Monitoring

• Observe closely for administration-related reactions and altered blood pressure.
• Monitor full blood count, including neutrophils and platelets.
• Monitor for infection, hepatitis B reactivation and hypogammaglobulinaemia.
• Investigate new neurological, cognitive or psychiatric symptoms promptly for possible PML.
• Monitor patients with cardiac disease or previous cardiotoxic therapy closely.
• Assess local reactions after subcutaneous administration.

Clinical pharmacology

Rituximab is a chimeric IgG1 monoclonal antibody against CD20. Its Fc region recruits immune-effector mechanisms that produce B-cell lysis. The subcutaneous formulation also contains recombinant human hyaluronidase to aid dispersion and absorption.

Formulation and product differences

• The selected Ruxience product is an intravenous concentrate with oncology and autoimmune indications.
• The selected MabThera subcutaneous product is restricted to specified adult non-Hodgkin lymphomas.
• Subcutaneous treatment must follow successful full intravenous administration and is injected only into the abdominal wall.
• Administration-related reactions occur with both routes; local skin reactions are particularly associated with the subcutaneous formulation.

Solution for infusion

Route: Intravenous

Strengths: 100 mg, 500 mg

Injection

Route: Parenteral

Strengths: 1400 mg