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Better survival.
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Systemic Anti-Cancer Therapy Regimen Library

GU URO Advanced - enfortumab vedotin and pembrolizumab

Treatment Overview

Continue until disease progression or unacceptable toxicity (up to 2 years for pembrolizumab).

Cycle 1 (and all further cycles) - 21 days

Cycle length:
21

Cycle details

Cycle 1 (and all further cycles) - 21 days

Medication Dose Route Days Max Duration
ondansetron 8 mg oral administration 1, 8
enfortumab vedotin 1.25 mg/kg Cap dose per administration at: 125 mg intravenous 1, 8 30 minutes
pembrolizumab 200 mg flat dosing intravenous 1 30 minutes
domperidone 10 mg Three times daily oral administration 1

Full details

Cycle 1 (and all further cycles) - 21 days

Day: 1

Medication Dose Route Max duration Details
ondansetron 8 mg oral administration
Instructions:

ONE hour prior to chemotherapy.

  • Alternative is dexamethasone 4 mg.
enfortumab vedotin 1.25 mg/kg Cap dose per administration at: 125 mg intravenous 30 minutes
pembrolizumab 200 mg flat dosing intravenous 30 minutes
Instructions:
Administer via a sterile, non-pyrogenic, low protein binding 0.2 to 5 micron in-line or add-on filter.
domperidone 10 mg Three times daily oral administration
Instructions:

When required for nausea and/or vomiting.

  • The choice of rescue antiemetic may be substituted to reflect institutional policy or individual patient characteristics.

Day: 8

Medication Dose Route Max duration Details
ondansetron 8 mg oral administration
Instructions:

ONE hour prior to chemotherapy.

  • Alternative is dexamethasone 4 mg.
enfortumab vedotin 1.25 mg/kg Cap dose per administration at: 125 mg intravenous 30 minutes

Supportive Care Factors

Factor Value
Emetogenicity: Low
Hypersensitivity / Infusion related reaction risk: Low - routine premedication not recommended

References

Powles T, Valderrama BP, Gupta S, et al; EV-302 Trial Investigators. Enfortumab Vedotin and Pembrolizumab in Untreated Advanced Urothelial Cancer. N Engl J Med. 2024 Mar 7;390(10):875-888., PMID: 38446675

Astellas Pharma Australia Pty Ltd. PADCEV (enfortumab vedotin) Australian Data Sheet 18 May 2023. https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2022-PI-01699-1&d=20241202172310101 (Accessed 3 December 2024)

Merck Sharp & Dohme (New Zealand) Limited. Keytruda New Zealand Data Sheet 6 November 2024. https://www.medsafe.govt.nz/profs/Datasheet/k/Keytruda.pdf (Accessed 3 December 2024).

* The medicines, doses, combinations, and schedule in this treatment regimen have been carefully reviewed against international best practice guidelines by specialists in medical oncology around New Zealand and this advice has been accepted for publication by Te Aho o Te Kahu (the Cancer Control Agency). Sometimes medicines that are used in routine clinical practice have not been through a formal review process by the NZ Medicines Regulator Medsafe and are therefore considered unapproved or off-label. These medicines are legally able to be prescribed through sections 25 and 29 of the Medicines Act and by obtaining informed consent from patients. All treatment regimens listed on this website have been through robust peer review and are considered an accepted standard of care, whether prescribed through sections 25 or 29 or carrying formal Medsafe Approval.

s29: This symbol indicates that some formulations of the associated medicine are legally only able to be prescribed under section 29 of the Medicines Act. You can see which formulations are section 29 by hovering over the s29 symbol. You can access full medication details from the New Zealand Formulary by clicking on the medication name. Each clinician retains full responsibility for ensuring they have complied with all relevant obligations and requirements of section 29 including obtaining informed patient consent prior to prescribing the applicable medicine.