Polivy and Management of Extravasation

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

This article responds to your request for information on Polivy® (polatuzumab-vedotin) and the management of extravasation.

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Last updated September 14, 2023

Summary

  • Polivy is an ADC comprised of an anti-CD79b monoclonal antibody and the anti-mitotic agent, MMAE linked through a protease-cleavable linker.
    • Polivy is not a vesicant; however, due to the class-effect of the MMAE component Polivy could be considered an irritant with potential for vesicant-like properties in the case of extravasation.
      • There is no specific treatment recommendation following extravasation of Polivy.
        • In cases of extravasation, the Polivy infusion should be stopped and symptoms of extravasation should be treated as per your institution's protocol for management of extravasation.

          Abbreviations

          ADC = antibody-drug conjugate

          ESMO = European Society for Medical Oncology

          MMAE = mono-methyl auristatin E

          NHS = National Health Service

          Vesicants, irritants, and non-vesicants

          Chemotherapy drugs may be classified based on their potential to cause tissue damage if extravasation occurs: [1]

          • Vesicants — These drugs may cause pain, inflammation, blistering, tissue death, and necrosis of local skin and underlying structures.
            • Irritants — These drugs may cause pain, inflammation, or irritation but rarely tissue breakdown.
              • Non-vesicants — These drugs are inert or neutral compounds that may cause pain but not inflammation or damage.
                  

                Any chemotherapy drugs have the potential to cause significant symptoms and tissue damage if the volume or concentration of the drug that extravasated is high.[1]

                Potential for Polivy to cause tissue damage after extravasation

                Polivy is an ADC comprised of an anti-CD79b monoclonal antibody and the anti-mitotic agent, MMAE linked through a protease-cleavable linker (maleimidocaproyl-valine-citrulline-p-aminobenzyloxycarbonyl).[2]

                An internal review of non-clinical and clinical data determined that Polivy is not a vesicant; however, due to the class-effect of the MMAE component Polivy could be considered an irritant with potential for vesicant-like properties in the case of extravasation.[3]

                Recommendations for the management of extravasation of Polivy

                There is no specific treatment recommendation following extravasation of Polivy. Please refer to your institution's protocol for management of extravasation.

                The study protocol for a Polivy pivotal clinical trial did not include guidance for management of extravasation.[4]

                Clinical guidelines

                Resources for the management of extravasation with chemotherapeutic agents have been published.[1,5,6] Examples include but are not limited to clinical practice guidelines published by ESMO [1] and the NHS [5].

                The ESMO guidelines recommend that in cases of extravasation, the infusion should be stopped and symptoms of extravasation should be treated.[1] Please refer to the full guidelines for further information.

                Extravasation experience from case reports

                Currently there are no case reports published for extravasation of Polivy.

                References

                1. Pérez FJ, García FL, Cervantes A, et al. Management of chemotherapy extravasation: ESMO-EONS Clinical Practice Guidelines. Ann Oncol 2012;23 Suppl 7:vii167-73. https://www.ncbi.nlm.nih.gov/pubmed/22997449
                  1. Palanca-Wessels M, Czuczman M, Salles G, et al. Safety and activity of the anti-CD79B antibody-drug conjugate polatuzumab vedotin in relapsed or refractory B-cell non-Hodgkin lymphoma and chronic lymphocytic leukaemia: a phase 1 study. Lancet Oncol 2015;16:704-15. https://www.ncbi.nlm.nih.gov/pubmed/25925619
                    1. Roche Internal Safety Report (Accessed on 17 August 2023).
                      1. Tilly H, Morschhauser F, Sehn L, et al. Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma. N Engl J Med 2022;386:351-363. https://www.ncbi.nlm.nih.gov/pubmed/34904799
                        1. Network Guidelines for the Management of Extravasation of a Systemic Anti-Cancer Therapy Including Cytotoxic Agents. Available at https://www.england.nhs.uk/mids-east/cancer-expert-advisory-groups/systemic-anti-cancer-therapy/. Accessed on August 4, 2023.
                          1. Kreidieh F, Moukadem H, El SN. Overview, prevention and management of chemotherapy extravasation. World J Clin Oncol 2016;7:87-97. https://www.ncbi.nlm.nih.gov/pubmed/26862492

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