ipilimumab: clinical use

Prescribing considerations

• Treatment should be initiated and supervised by clinicians experienced in cancer treatment.
• Confirm PD-L1 or MSI-H/dMMR status with an appropriate validated test where required by the licensed indication.
• Review product information for nivolumab, chemotherapy and other combination components.
• Combination immunotherapy causes immune-related toxicity more often than nivolumab alone; consider tumour characteristics, disease tempo and individual risk.
• Record the product name and batch number for biological traceability.

Contraindications and cautions

• Hypersensitivity to ipilimumab or an excipient.
• Avoid in severe active autoimmune disease where further immune activation could be imminently life-threatening.
• Use caution with other autoimmune disease, organ transplantation, baseline systemic immunosuppression, previous severe immune-mediated skin reactions, lung inflammation or significant hepatic impairment.

Monitoring

• Assess baseline clinical status and check liver and thyroid function before treatment administrations.
• Monitor renal function, glucose, electrolytes and other tests according to clinical context and combination therapy.
• Assess bowel, skin, respiratory, hepatic, endocrine, neurological, cardiac, muscular, renal and ocular symptoms.
• Exclude infection, cancer progression and other causes when immune-related toxicity is suspected. Diarrhoea or colitis requires infectious evaluation, including CMV where appropriate.
• Remain vigilant after treatment stops because delayed immune-related reactions occur.

Clinical pharmacology

A fully human IgG1κ monoclonal antibody that blocks CTLA-4-mediated inhibitory signalling, increasing effector T-cell activity and altering the effector-to-regulatory T-cell balance within tumours. It is not metabolised by CYP enzymes and has a prolonged terminal elimination half-life.

Formulation and product differences

• The selected product is a sterile concentrate for intravenous infusion and may be used undiluted or diluted with compatible sodium chloride or glucose infusion fluid.
• It must not be given by intravenous push or bolus, mixed with other medicines, or infused simultaneously through the same line.
• The formulation contains sodium; consider this for people following a controlled-sodium diet.

Solution for infusion

Route: Intravenous

Strengths: 5 mg/mL