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References

References

References

 
  1. Criscione VD, Weinstock MA. Incidence of cutaneous T-cell lymphoma in the United States. Arch Dermatol. 2007;143(7):854-859.
  2. CTCL-MF fast facts. Cutaneous Lymphoma Foundation Web site.
    http://www.clfoundation.org/about_cutaneous_lymphoma/CL_fast_facts.htm.
  3. Cutaneous T-cell lymphoma. The Lymphoma & Leukemia Society. http://leukemia-lymphoma.org/attachments/National/br_1163608564.pdf. Accessed September 18, 2009.
  4. Data on file, Therakos, Inc.
  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. 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; December 8-11, 2007; Atlanta, GA. Abstract 2561.
  7. McCann SA. Cutaneous T-cell lymphoma: overview and nursing perspectives. Nurs Clin North Am. 2007;42(3):421-455, vi-vii.
  8. McKenna KE, Whittaker S, Rhodes LE, et al; British Photodermatology Group; U.K. Skin Lymphoma Group. Evidence-based practice of photopheresis 1987-2001: a report of a workshop of the British Photodermatology Group and the U.K. Skin Lymphoma Group. Br J Dermatol. 2006;154(1):7-20.
  9. Mycosis fungoides and Sézary syndrome Treatment. National Cancer Institute Web site. http://www.cancer.gov.
  10. Mycosis fungoides/Sézary syndrome. In: NCCN Clinical Practice Guidelines in Oncology: Non-Hodgkin's Lymphomas. v.1.2009. Fort Washington, PA: National Comprehensive Cancer Network; 2009:MFSS-1-MFSS-B.2.:70.
  11. 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.
  12. THERAKOS™ CELLEX® Photopheresis System Operator's Manual. Rev. 3.0-1460436.
  13. UVADEX® (methoxsalen) Sterile Solution Prescribing Information. Manufactured by Ben Venue Laboratories, Bedford, OH 44146-0568 for Therakos, Inc, a Johnson & Johnson Company, Exton, PA, 19341.
  14. Willemze R, Jaffe ES, Burg G, et al. WHO-EORTC classification for cutaneous lymphomas. Blood. 2005;105(10):3768-3785.
  15. Zelenetz AD, Abramson JS, Advani RH, et al. NCCN Clinical Practice Guidelines in Oncology. 2009. www.nccn.org. Accessed September 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 is not appropriate for patients who have had a reaction to psoralen compounds, patients who have had a light sensitive disease, or patients with an absence of one or both lenses of the eye.

THERAKOS Photopheresis is not appropriate for patients who cannot tolerate blood volume changes or patients with blood clotting disorders. See Important Safety Information for additional details.

 
 

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