Important Safety Information for THERAKOS® CELLEX® Photopheresis Procedure

INDICATION

The THERAKOS® CELLEX® Photopheresis System is indicated for use in the ultraviolet-A (UVA) irradiation, in the presence of the photoactive drug 8-methoxypsoralen (8-MOP), of extracorporeally circulating leukocyte-enriched blood, in the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL) and systemic sclerosis (SSc).

CONTRAINDICATIONS

Certain underlying medical conditions contraindicate THERAKOS CELLEX Photopheresis, including:

WARNINGS & PRECAUTIONS

THERAKOS CELLEX Photopheresis treatments should always be performed in locations where standard medical emergency equipment is available. Volume replacement fluids and/or volume expanders should be readily available throughout the procedure.

ADVERSE REACTIONS

Hypotension may occur during any treatment involving extracorporeal circulation. Monitor the patient closely during the entire treatment.

Transient pyretic reactions, 37.7-38.9 °C (100-102 °F), have been observed in some patients within 6-8 hours of reinfusion of the photoactivated leukocyte-enriched blood. A temporary increase in erythroderma may accompany the pyretic reaction.

Treatment frequency exceeding labeling recommendations may result in anemia.

Venous access carries a small risk of infection and pain.

Important Safety Information for Methoxsalen Sterile Solution Used in Conjunction with THERAKOS® CELLEX® Photopheresis System

CONTRAINDICATIONS

Methoxsalen Sterile Solution is contraindicated in:

SERIOUS WARNINGS & PRECAUTIONS

FOR MORE INFORMATION

See product monograph for methoxsalen sterile solution (if used in conjunction with the THERAKOS CELLEX Photopheresis System) and the Operator’s Manual for the CELLEX system at health-products.canada.ca/dpd-bdpp or by calling 1-833-223-4ECP (1-833-223-4327).

References:

  1. Knobler R, et al. J Eur Acad Dermatol Venereol. 2014;28(suppl 1):1-37.
  2. Health Canada Medical Devices Active Licence Listing Database. https://health-products.canada.ca/mdall-limh/information.do?companyId_idCompanie=129103&lang=eng. Accessed May 27, 2021.
  3. Therakos LLC. Data on File. February 2021.

References:

  1. Therakos, Inc. Operator’s Manual. THERAKOS™ CELLEX™ Photopheresis System.
  2. Bisaccia E, et al. Br J Dermatol. 2009;161(1):167-169.
  3. Knobler R, et al. J Eur Acad Dermatol Venereol. 2014;28(suppl 1):1-37.
  4. Perotti C, Sniecinski I. Transfus Apher Sci. 2015;52(3):360-368.
  5. Hart JW, et al. Ther Adv Hematol. 2013;4:320-334.
  6. UVADEX (methoxsalen) Product Monograph. West Chester, PA, USA: Therakos, Inc.: May 2013.
  7. Rook AH, et al. Arch Dermatol. 1992;128(3):337-346.
  8. Knobler R, et al. J Am Acad Dermatol. 2006;54:793-799.
  9. Therakos LLC. Data on File. February 2021.
  10. European Council. Council Directive 93/42/EEC. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31993L0042&from=EN. Accessed February 9, 2021.
  11. International Organization for Standardization. ISO 9001:2015 Quality Management Systems – Requirements. Published online September 2019. https://www.iso.org/standard/62085.html. Accessed March 16, 2021.
  12. International Organization for Standardization. ISO 13485:2003 Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes. Published online July 2003. https://www.iso.org/standard/36786.html. Accessed March 16, 2021.
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