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A practical guide to the handling and administration of talimogene laherparepvec in Europe
Talimogene laherparepvec is a herpes simplex virus-1-based intralesional oncolytic immunotherapy and is the first oncolytic virus to be approved in Europe. It is indicated for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (stage IIIB, IIIC, and IVM1a)...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Dove Medical Press
2017
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5546812/ https://www.ncbi.nlm.nih.gov/pubmed/28814886 http://dx.doi.org/10.2147/OTT.S133699 |
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author | Harrington, Kevin J Michielin, Olivier Malvehy, Josep Pezzani Grüter, Isabella Grove, Lorna Frauchiger, Anna Lisa Dummer, Reinhard |
author_facet | Harrington, Kevin J Michielin, Olivier Malvehy, Josep Pezzani Grüter, Isabella Grove, Lorna Frauchiger, Anna Lisa Dummer, Reinhard |
author_sort | Harrington, Kevin J |
collection | PubMed |
description | Talimogene laherparepvec is a herpes simplex virus-1-based intralesional oncolytic immunotherapy and is the first oncolytic virus to be approved in Europe. It is indicated for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (stage IIIB, IIIC, and IVM1a) with no bone, brain, lung, or other visceral disease. Talimogene laherparepvec is a genetically modified viral therapy, and its handling needs special attention due to its deep freeze, cold-chain requirements, its potential for viral shedding, and its administration by direct intralesional injection. This review provides a practical overview of handling, storage, and administration procedures for this agent in Europe. Talimogene laherparepvec vials should be transported/stored frozen at a temperature of −90°C to −70°C, and once thawed, vials must not be refrozen. Universal precautions for preparation, administration, and handling should be followed to avoid accidental exposure. Health care providers should wear personal protective equipment, and materials that come into contact with talimogene laherparepvec should be disposed of in accordance with local institutional procedures. Individuals who are immunocompromised or pregnant should not prepare or administer this agent. Talimogene laherparepvec is administered by intralesional injection into cutaneous, subcutaneous, and/or nodal lesions that are visible, palpable, or detectable by ultrasound. Treatment should be continued for ≥6 months. As with other immunotherapies, patients may experience an increase in the size of existing lesion(s) or the appearance of new lesions (ie, progression) prior to achieving a response (“pseudo-progression”). As several health care professionals (eg, physicians [dermatologists, surgeons, oncologists, radiologists], pharmacists, nurses) are involved in different stages of the process, there is a need for good interdisciplinary collaboration when using talimogene laherparepvec. Although there are specific requirements for this agent’s storage, handling, administration, and disposal, these can be effectively managed in a real-world clinical setting through the implementation of training programs and straightforward standard operating procedures. |
format | Online Article Text |
id | pubmed-5546812 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | Dove Medical Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-55468122017-08-16 A practical guide to the handling and administration of talimogene laherparepvec in Europe Harrington, Kevin J Michielin, Olivier Malvehy, Josep Pezzani Grüter, Isabella Grove, Lorna Frauchiger, Anna Lisa Dummer, Reinhard Onco Targets Ther Review Talimogene laherparepvec is a herpes simplex virus-1-based intralesional oncolytic immunotherapy and is the first oncolytic virus to be approved in Europe. It is indicated for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (stage IIIB, IIIC, and IVM1a) with no bone, brain, lung, or other visceral disease. Talimogene laherparepvec is a genetically modified viral therapy, and its handling needs special attention due to its deep freeze, cold-chain requirements, its potential for viral shedding, and its administration by direct intralesional injection. This review provides a practical overview of handling, storage, and administration procedures for this agent in Europe. Talimogene laherparepvec vials should be transported/stored frozen at a temperature of −90°C to −70°C, and once thawed, vials must not be refrozen. Universal precautions for preparation, administration, and handling should be followed to avoid accidental exposure. Health care providers should wear personal protective equipment, and materials that come into contact with talimogene laherparepvec should be disposed of in accordance with local institutional procedures. Individuals who are immunocompromised or pregnant should not prepare or administer this agent. Talimogene laherparepvec is administered by intralesional injection into cutaneous, subcutaneous, and/or nodal lesions that are visible, palpable, or detectable by ultrasound. Treatment should be continued for ≥6 months. As with other immunotherapies, patients may experience an increase in the size of existing lesion(s) or the appearance of new lesions (ie, progression) prior to achieving a response (“pseudo-progression”). As several health care professionals (eg, physicians [dermatologists, surgeons, oncologists, radiologists], pharmacists, nurses) are involved in different stages of the process, there is a need for good interdisciplinary collaboration when using talimogene laherparepvec. Although there are specific requirements for this agent’s storage, handling, administration, and disposal, these can be effectively managed in a real-world clinical setting through the implementation of training programs and straightforward standard operating procedures. Dove Medical Press 2017-08-02 /pmc/articles/PMC5546812/ /pubmed/28814886 http://dx.doi.org/10.2147/OTT.S133699 Text en © 2017 Harrington et al. This work is published and licensed by Dove Medical Press Limited The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. |
spellingShingle | Review Harrington, Kevin J Michielin, Olivier Malvehy, Josep Pezzani Grüter, Isabella Grove, Lorna Frauchiger, Anna Lisa Dummer, Reinhard A practical guide to the handling and administration of talimogene laherparepvec in Europe |
title | A practical guide to the handling and administration of talimogene laherparepvec in Europe |
title_full | A practical guide to the handling and administration of talimogene laherparepvec in Europe |
title_fullStr | A practical guide to the handling and administration of talimogene laherparepvec in Europe |
title_full_unstemmed | A practical guide to the handling and administration of talimogene laherparepvec in Europe |
title_short | A practical guide to the handling and administration of talimogene laherparepvec in Europe |
title_sort | practical guide to the handling and administration of talimogene laherparepvec in europe |
topic | Review |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5546812/ https://www.ncbi.nlm.nih.gov/pubmed/28814886 http://dx.doi.org/10.2147/OTT.S133699 |
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