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References

References

References

 
  1. Berger CL, Hanlon D, Kanada D, Girardi M, Edelson RL. Transimmunization, a novel approach for tumor immunotherapy. Transfus Apher Sci. 2002;26(3):205-216.
  2. Cutaneous T cell lymphoma. The Lymphoma & Leukemia Society. Available at: http://leukemia-lymphoma.org/attachments/National/br_1163608564.pdf. Accessed September 18, 2009.
  3. Data on file, Therakos, Inc.
  4. Di Renzo M, Sbano P, De Aloe G, Pasqui AL, Rubegni P, Ghezzi A, et al. Extracorporeal photopheresis affects co-stimulatory molecule expression and interleukin-10 production by dendritic cells in graft-versus-host disease patients. Clinical Exp Immunol. 2008;151(3):407-413.
  5. Edelson R, Berger C, Gasparro F, et al. Treatment of cutaneous T-cell lymphoma by extracorporeal photochemotherapy. Preliminary results. N Engl J Med. 1987;316(6):297-303.
  6. Foss FM, Gorgun G, Miller KB. Extracorporeal photopheresis in chronic graft-versus-host disease. Bone Marrow Transplant. 2002;9:719-25.
  7. Gardner JM, Evans KG, Musiek A, Rook AH, Kim EJ. Update on treatment of cutaneous T-cell lymphoma. Curr Opin Oncol. 2009, 21:131–137.
  8. Gatza E, Rogers CE, Clouthier SG, Lowler KP, Tawara I, Liu C, et al. Extracorporeal photopheresis reverses experimental graft-versus-host disease through regulatory T cells. Blood. 2008;112(4):1515-1521.
  9. Geskin LJ, Foss F, Duvic M, et al. Efficacy of extracorporeal photopheresis (ECP) monotherapy in the treatment of cutaneous T-cell lymphoma. Poster presented at: The American Society of Hematology 49th Annual Meeting and Exposition; 2007; Atlanta, GA. Abstract 2561.
  10. Gorgun G, Miller KB, Foss FM. Immunologic mechanisms of extracorporeal photochemotherapy in chronic graft-versus-host disease. Blood. 2002;100(3):941-947.
  11. Kim YM, Liu HL, Mraz-Gernhard S, Varghese A, Hoppe RT. Long-term outcome of 525 patients with mycosis fungoides and Sézary syndrome: clinical prognostic factors and risk for disease progression. Arch Dermatol. 2003;139:857-866.
  12. Lamioni A, Carsetti R, Legato A, Landolfo A, Isacchi G, Emma F, et al. The immunological effects of extracorporeal photopheresis unraveled: induction of tolerogenic dendritic cells in vitro and regulatory T cells in vivo. Transplantation. 2005;799(7):846-850.
  13. McKenna KE, Whittaker S, Rhodes LE, et al. Evidence-based practice of photopheresis 1987-2001: a report of a workshop of the British Photodermatology Group and the UK Skin Lymphoma Group. Br J Dermatol. 2006;154:7-20.
  14. Olsen E, Vonderheid E, Pimpinelli N, et al. Revisions to the staging and classification of mycosis fungoides and Sézary syndrome: a proposal of the International Society for Cutaneous Lymphomas (ISCL) and the cutaneous lymphoma task force of the European Organization of Research and Treatment of Cancer (EORTC). Blood. 2007;110:1713-1722.
  15. Suchin KR, Cassin M, Washko R, et al. Extracorporeal photochemotherapy does not suppress T- or B-cell responses to novel or recall antigens. J Am Acad Dermatol. 1999;41(6):980-986.
  16. UVADEX® (methoxsalen) Sterile Solution Prescribing Information. Manufactured by Ben Venue Laboratories, Bedford ,OH 44146-0568 for Therakos, A Johnson & Johnson Company, Exton, PA, 19341.
  17. Willemze R, Jaffe ES, Burg G, etc. WHO-EORTC classification for cutaneous lymphomas. Blood. 2005;105:3768-3785.
  18. Zelenetz AD, Abramson JS, Advani RH, et al. NCCN Clinical Practice Guidelines in Oncology – v.2.2009. www.nccn.org. Accessed Sept 18, 2009.

 

 

Important Safety Information

Indications

Methoxsalen Sterile Solution is indicated for extracorporeal administration with the THERAKOS™ UVAR XTS® or THERAKOS™ CELLEX® Photopheresis System in the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL) that is unresponsive to other forms of treatment.

Methoxsalen should be used only by physicians who have special training in the THERAKOS™ UVAR XTS® or THERAKOS™ CELLEX® Photopheresis Systems. Methoxsalen is contraindicated in patients exhibiting idiosyncratic reactions to psoralen compounds, patients with a specific history of a light sensitive disease, or patients with aphakia.

THERAKOS™ Photopheresis is not appropriate for patients who cannot tolerate extracorporeal volume loss or shifts, or patients with coagulation disorders. See Important Safety Information for additional details.

 
 

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