Tisotumab vedotin: clinical use

Prescribing considerations

• Treatment should be initiated and supervised by a clinician experienced in anticancer therapy.
• Arrange baseline ophthalmic assessment, including visual acuity and slit-lamp examination, and repeat when clinically indicated.
• Assess pre-existing ocular surface disease, neuropathy, and hepatic or renal impairment.
• Confirm pregnancy status where relevant and provide contraception and fertility counselling.
• Review concomitant strong CYP3A4 inhibitors and inducers.
• Exposure to MMAE may increase in mild hepatic impairment; moderate or severe hepatic impairment has not been studied.
• Severe renal impairment and end-stage renal disease have not been studied.

Contraindications and cautions

• Hypersensitivity to tisotumab vedotin or any excipient.

Monitoring

• Inspect the eyes and ask about ocular symptoms before administration; refer promptly for new or worsening symptoms.
• Monitor for peripheral sensory or motor neuropathy.
• Monitor for blistering, peeling, mucosal lesions or other signs of severe cutaneous reactions.
• Review blood counts and assess anaemia, neutropenia, infection and bleeding.
• Record the product name and batch number for traceability.

Clinical pharmacology

A fully human IgG1-kappa antibody–drug conjugate targeting tissue factor, linked through a protease-cleavable linker to MMAE. Internalisation and MMAE release disrupt microtubules, causing cell-cycle arrest and apoptosis.

Formulation and product differences

• Powder for concentrate requiring reconstitution and dilution before intravenous infusion.
• The reconstituted product contains no preservative and is intended for single use.
• It must not be given by intravenous push or bolus.
• Excipients include histidine compounds, sucrose and mannitol.