nivolumab: clinical use

Prescribing considerations

• Confirm indication-specific tumour biomarkers with a validated test where required.
• Discuss immune-related risks, provide the patient card and ensure rapid access to the oncology team.
• Review autoimmune disease, interstitial lung disease, brain metastases, baseline immunosuppression, organ transplantation and previous severe reactions to immune-stimulatory therapy.
• Consider risks of solid-organ rejection and complications before or after allogeneic haematopoietic stem-cell transplantation.
• When used in combination, review the complete product information for every treatment component.

Contraindications and cautions

• Hypersensitivity to nivolumab or any excipient.
• Active autoimmune disease, symptomatic interstitial lung disease, systemic immunosuppression and transplant history are important cautions rather than universal labelled contraindications; evidence may be limited because these groups were often excluded from trials.

Monitoring

• Record product name and batch number for traceability.
• Assess symptoms and laboratory evidence of immune toxicity before and throughout treatment.
• Monitor liver function, renal function, thyroid function and blood glucose; investigate adrenal, pituitary, cardiac, pulmonary, neurological or gastrointestinal toxicity when clinically indicated.
• Exclude infection and cancer-related causes when evaluating suspected immune toxicity; diarrhoea or steroid-refractory colitis requires investigation for infection, including possible CMV.
• Continue vigilance after treatment stops because immune reactions may be delayed.

Clinical pharmacology

Human IgG4 monoclonal antibody against PD-1. Blocking PD-1 interaction with PD-L1 and PD-L2 enhances T-cell activity, including antitumour responses. Nivolumab is not expected to undergo CYP metabolism.

Formulation and product differences

• The intravenous product is a concentrate for infusion that may require aseptic dilution and must not be given as an intravenous push or bolus.
• The subcutaneous product is a ready-to-use solution containing recombinant human hyaluronidase and must not be administered intravenously.
• Subcutaneous safety is broadly similar to intravenous nivolumab, with injection-site reactions as an additional formulation-related effect.
• The intravenous formulation includes the licensed adolescent melanoma indication; the selected subcutaneous product is licensed for adults.

Solution for infusion

Route: Intravenous

Strengths: 10 mg/mL

Injection

Route: Parenteral

Strengths: 600 mg