Columvi 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 ColumviTM (glofitamab) and the management of extravasation.

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Last updated May 17, 2024

Summary

  • Columvi is a monoclonal antibody.
    • Monoclonal antibodies are classified as non vesicants or as irritants. Extravasation of Columvi is not expected to result in outcomes typical for vesicants.
      • There is no specific treatment recommendation following extravasation of Columvi.
        • In cases of extravasation, the Columvi infusion should be stopped and symptoms of extravasation should be treated as per your institution's protocol for management of extravasation.

          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 Columvi to cause tissue damage after extravasation

                Columvi is a monoclonal antibody.[2] Monoclonal antibodies are either classified as non vesicants [1,3] or as irritants due to the possibility of local allergic reactions rather than direct cellular toxicity.[4] Extravasation of Columvi is not expected to result in outcomes typical for vesicants. 

                Recommendations for the management of extravasation of Columvi

                There is no specific treatment recommendation following extravasation of Columvi.[5] Please refer to your institution's protocol for management of extravasation.

                The study protocol for a Columvi pivotal clinical trial did not include guidance for management of extravasation.[6]

                Clinical guidelines

                Resources for the management of extravasation with chemotherapeutic agents have been published.[1,3,7] Examples include but are not limited to clinical practice guidelines published by the European Society for Medical Oncology (ESMO) [1] and the National Health Service (NHS).[7]

                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 Columvi.

                References

                1. Pérez FJA, 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. Dickinson MJ, Carlo-Stella C, Morschhauser F, et al. Glofitamab for Relapsed or Refractory Diffuse Large B-Cell Lymphoma. N Engl J Med 2022;387:2220-2231. https://www.ncbi.nlm.nih.gov/pubmed/36507690
                    1. Kreidieh FY, Moukadem HA, El SNS. Overview, prevention and management of chemotherapy extravasation. World J Clin Oncol 2016;7:87-97. https://www.ncbi.nlm.nih.gov/pubmed/26862492
                      1. Pluschnig U, Haslik W, Bartsch R, et al. Extravasation emergencies: state-of-the-art management and progress in clinical research. Memo 2016;9:226-230. https://www.ncbi.nlm.nih.gov/pubmed/28058065
                        1. Roche Internal Regulatory Document (Accessed on 14 May 2024).
                          1. Protocol for Glofitamab for relapsed or refractory diffuse large B-cell lymphoma. Available at https://www.nejm.org/doi/suppl/10.1056/NEJMoa2206913/suppl_file/nejmoa2206913_protocol.pdf. Accessed on May 14, 2024.
                            1. Network Guidelines for the Management of Extravasation of a Systemic Anti-Cancer Therapy Including Cytotoxic Agents. Available at https://www.england.nhs.uk/midlands/wp-content/uploads/sites/46/2019/05/management-extravasation-of-a-systemic-anti-cancer-therapy-including-cytotoxic-agents.pdf. Accessed on May 16, 2024.

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