Pharmacokinetics-Based Safety Evaluation in Half-Dose Verteporfin Photodynamic Therapy.

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  • Additional Information
    • Source:
      Publisher: Karger Country of Publication: Switzerland NLM ID: 0267442 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1423-0259 (Electronic) Linking ISSN: 00303747 NLM ISO Abbreviation: Ophthalmic Res Subsets: MEDLINE
    • Publication Information:
      Original Publication: Basel, New York, Karger.
    • Subject Terms:
      Verteporfin*/pharmacokinetics ; Verteporfin*/administration & dosage ; Photochemotherapy*/methods ; Photosensitizing Agents*/pharmacokinetics ; Photosensitizing Agents*/administration & dosage; Humans ; Male ; Macular Degeneration/drug therapy ; Female ; Porphyrins/pharmacokinetics ; Porphyrins/administration & dosage ; Dose-Response Relationship, Drug
    • Abstract:
      Introduction: This study was conducted to assess the systemic pharmacokinetic profiles of half-dose verteporfin photodynamic therapy (PDT) using concentration data from a previous clinical trial and to subsequently suggest safety precaution guidelines.
      Methods: Coefficients for the bi-exponential model were obtained from published data on post-infusion plasma verteporfin concentrations within a period of 0.17-4 h. Using the extrapolative forecasting method, we plotted the 48-h post-verteporfin plasma concentration model. The time required to achieve a comparable level of verteporfin 48 h after a conventional dose (6 mg/m2 body surface area, BSA) infusion was calculated for a half-dose infusion (3 mg/m2 BSA).
      Results: At 24 and 48 h post-verteporfin infusion, the plasma concentration following the conventional dose was 1.28 × 10-4 µg/mL and 5.06 × 10-8 µg/mL, compared to 3.57 × 10-5 µg/mL and 7.54 × 10-9 µg/mL for the half-dose PDT, representing concentrations that were 3.6 times and 6.7 times higher, respectively. The estimated time required to attain the same level of verteporfin 48 h after a conventional dose was calculated as 42-h post-half-dose PDT.
      Conclusions: The results of this study indicate that precautionary measures should be taken to avoid sunlight following both half and conventional doses of PDT during the similar post-treatment periods of two days. Nevertheless, given the substantially higher plasma concentration levels associated with conventional-dose PDT compared with the half-dose, systemic safety should be carefully considered when administering conventional-dose PDT.
      (© 2024 The Author(s). Published by S. Karger AG, Basel.)
    • Contributed Indexing:
      Keywords: Pharmacokinetics; Photodynamic therapy; Photosensitivity; Verteporfin
    • Accession Number:
      0X9PA28K43 (Verteporfin)
      0 (Photosensitizing Agents)
      0 (Porphyrins)
    • Publication Date:
      Date Created: 20240926 Date Completed: 20241029 Latest Revision: 20241029
    • Publication Date:
      20241031
    • Accession Number:
      10.1159/000541619
    • Accession Number:
      39326395