{
  "abstract": "Background and Importance Tezepelumab is an anti-TSLP monoclonal antibody used in uncontrolled severe asthma. Hypersensitivity to excipients in biological therapies is a significant clinical challenge, as many of these components are shared among these. In most cases, treatment is avoided unless no therapeutic alternatives exist. In this context, the hospital pharmacy plays a crucial role preparing desensitisation protocols, ensuring traceability and maintaining process safety.Aim and Objectives To describe a subcutaneous desensitisation protocol to tezepelumab in a patient with severe asthma and polysorbate hypersensitivity, and to highlight the pharmacy service’s contribution to preparation, quality control and patient safety.Material and Methods A 48-year-old man with severe asthma allergic to polysorbate 80. Previous treatments included omalizumab (hypersensitivity in first dose) and dupilumab (both ineffective), benralizumab (discontinued due to an allergic reaction attributed to polysorbate 20), and reslizumab (ineffective, the only without polysorbate). Consequently, desensitisation to tezepelumab was proposed.Results The content of the commercial pen (CP) (210 mg/1.91 mL pen) was withdrawn using a syringe. A stepwise desensitisation protocol was designed based on the preparation of dilutions from the marketed formulation. Three solutions were prepared: A (0,71 mL CP + 0,29 mL saline solution 0,9% (SS)), B (0,61 mL CP + 0,39 mL SS) and X (0,59 mL CP + 2,51 mL SS). From the X solution five dilutions were prepared.Each dilution was administered subcutaneously every 20 minutes, with a total duration of 140 minutes and a cumulative dose of 210 mg. This process is repeated each 4 weeks. The solutions are prepared in a laminar flow cabin and it’s necessary to make a quality control by visual inspection.The patient initiated therapy with tezepelumab in 2023 with the first administration performed in the intensive care unit. To the date, he has completed 16 administrations and continues to receive the medication in the day hospital, maintaining adequate asthma control without severe hypersensitivity reactions.Conclusion and Relevance The role of the pharmacy service was essential in the development of a desensitisation protocol that ensured patient safety and minimised manipulation. This protocol contributes valuable evidence in a field with limited published data and may serve as a model for future desensitisation strategies.Conflict of Interest No conflict of interest",
  "authors": [
    {
      "affiliations": [
        "A Coruña University Hospital Complex, Pharmacy Department, A Coruña, Spain"
      ],
      "name": "M Vázquez Vázquez"
    },
    {
      "affiliations": [
        "A Coruña University Hospital Complex, Pharmacy Department, A Coruña, Spain"
      ],
      "name": "MB Feal Cortizas"
    },
    {
      "affiliations": [
        "A Coruña University Hospital Complex, Pharmacy Department, A Coruña, Spain"
      ],
      "name": "M Mateos Salvador"
    },
    {
      "affiliations": [
        "A Coruña University Hospital Complex, Pharmacy Department, A Coruña, Spain"
      ],
      "name": "MM Calvín Lamas"
    },
    {
      "affiliations": [
        "A Coruña University Hospital Complex, Pharmacy Department, A Coruña, Spain"
      ],
      "name": "A Torres Pérez"
    },
    {
      "affiliations": [
        "A Coruña University Hospital Complex, Pharmacy Department, A Coruña, Spain"
      ],
      "name": "M Neira Rodríguez-Hermida"
    },
    {
      "affiliations": [
        "A Coruña University Hospital Complex, Pharmacy Department, A Coruña, Spain"
      ],
      "name": "C Fernández Diz"
    },
    {
      "affiliations": [
        "A Coruña University Hospital Complex, Pharmacy Department, A Coruña, Spain"
      ],
      "name": "E Gómez Costa"
    },
    {
      "affiliations": [
        "A Coruña University Hospital Complex, Pharmacy Department, A Coruña, Spain"
      ],
      "name": "L Caeiro Martínez"
    },
    {
      "affiliations": [
        "Research Group of Hospital Pharmacy. Biomedical Research Institute A Coruña Inibic. A Coruña University Hospital Chuac- Sergas. A Coruña University Udc., Pharmacy Department, A Coruña, Spain"
      ],
      "name": "L Margusino Framiñán"
    }
  ],
  "title": "4CPS-221 Tezepelumab desensitisation protocol in a patient allergic to polysorbate: a case report",
  "uid": "796448a7-065a-5411-aa44-2fb1d971cbec"
}