Toripalimab: clinical use

Prescribing considerations

• Initiate and supervise treatment through clinicians experienced in cancer therapy.
• Review autoimmune disease, interstitial lung disease, active infection, immunosuppression, CNS metastases and transplant history.
• Evidence is limited in severe renal impairment and moderate-to-severe hepatic impairment.
• Provide and explain the patient alert card; record product name and batch number for traceability.
• Exercise particular caution where immune activation could worsen autoimmune disease or precipitate transplant complications.

Contraindications and cautions

• Hypersensitivity to toripalimab or any excipient.

Monitoring

• Assess for immune-related toxicity before treatment and throughout follow-up, including after discontinuation.
• Check liver enzymes, creatinine and thyroid function at baseline and periodically; investigate symptoms promptly and exclude other causes.
• Monitor blood counts and parameters required for accompanying chemotherapy.
• Observe during infusion for hypersensitivity or infusion-related reactions.

Clinical pharmacology

A humanised IgG4 monoclonal antibody targeting PD-1. Blocking PD-1 interaction with PD-L1 and PD-L2 restores T-cell proliferation, cytokine production and cytotoxic activity. It is cleared through protein catabolism rather than cytochrome P450 metabolism.

Formulation and product differences

• Concentrate requiring dilution for intravenous infusion through an in-line filter.
• Supplied as a single-use vial; it must not be mixed or co-administered through the same infusion line with other medicines.
• The undiluted product is essentially sodium-free, although the infusion diluent contains sodium.

Solution for infusion

Route: Intravenous

Strengths: 240 mg