enfortumab vedotin: prescribing and clinical use
Focused clinical detail for use alongside current product information, local policy and patient-specific assessment.
enfortumab vedotin: clinical details
Prescribing considerations
- Confirm that the tumour setting and previous treatment meet the licensed indication.
- Assess pre-existing diabetes or hyperglycaemia, neuropathy, skin disease, respiratory symptoms, infection and ocular problems.
- Moderate or severe hepatic impairment has limited supporting evidence and may increase MMAE exposure.
- End-stage renal disease has not been evaluated.
- Provide the patient leaflet and skin-reaction patient card; record product name and batch number for traceability.
Contraindications and cautions
- Hypersensitivity to enfortumab vedotin or any excipient.
Monitoring
- Inspect for skin reactions from treatment initiation onwards; urgently assess bullous lesions or suspected severe cutaneous adverse reactions.
- Check blood glucose before administration and periodically according to clinical risk.
- Monitor for new or worsening neuropathy, cough, dyspnoea, hypoxia, infection and ocular symptoms.
- Ensure secure venous access and monitor for extravasation during and after administration.
- Monitor for treatment-related haematological abnormalities, liver-enzyme changes and weight loss as clinically appropriate.
Clinical pharmacology
A fully human IgG1-kappa antibody–drug conjugate targeting Nectin-4. Internalisation and proteolytic linker cleavage release MMAE, causing microtubule disruption, cell-cycle arrest, apoptosis and immunogenic cell death.
Formulation and product differences
- Available as 20 mg and 30 mg single-dose vials of white to off-white powder for concentrate for intravenous infusion.
- After reconstitution, both vial strengths produce the same enfortumab vedotin concentration.
- Excipients include histidine, histidine hydrochloride monohydrate, trehalose dihydrate and polysorbate 20.
enfortumab vedotin preparations and strengths
Solution for infusion
Route: Intravenous
Strengths: 20 mg, 30 mg
enfortumab vedotin interactions
Formal interaction studies are limited. The oncology team should review prescribed, over-the-counter and herbal products.
Strong CYP3A4 inhibitors, including clarithromycin, itraconazole, posaconazole, voriconazole, cobicistat and ritonavir
May increase exposure to the cytotoxic component; monitor more closely for toxicity.
Strong CYP3A4 inducers, including rifampicin, carbamazepine, phenobarbital and phenytoin
May reduce exposure to the cytotoxic component and potentially alter treatment effect.
St John’s wort
May reduce exposure to the cytotoxic component; tell the cancer team before using it.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.