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Important Safety Information

Healthcare professionals

What do you get when you choose
THERAKOS ECP Immunomodulation™?

ECP Strength

  • Evidence-based Treatment11-19
  • Immunomodulation3-5
  • Cost-effectiveness21-24

THERAKOS ECP EDGE

  • CELLEXTM System Performance25,26
  • Validated Technology11,26,27
  • Patient & Customer Focus
  • Access & Delivery Support
  • The Therakos Institute

Explore our website or contact your local representative to find out more

THERAKOS ECP ImmunomodulationTM

Find out more about our therapy
and its clinical applications

THERAKOSTM CELLEXTM Photopheresis System

Learn about the world’s only fully
integrated and validated ECP system

Research opportunities & Educational grants

DISCOVER EDUCATIONAL GRANTS AND RESEARCH
OPPORTUNITIES AVAILABLE TO YOU

Health Economics

LEARN ABOUT the potential economic benefits of
choosing CELLEXTM, and find out about our
funding support services

Customer support

Get in touch with us

References:

1. Operator’s Manual. THERAKOSTM CELLEXTM Photopheresis System. Therakos. 2019. 2. Hart JW, et al. Ther Adv Hematol. 2013;4:320-334. 3. Wang L, et al. Front Immunol. 2018;9:2207. 4. Ni M, et al. Front Immunol. 2019;10:547. 5. Mankarious M, et al. Front Immunol. 2020;11:81. 6. Dignan FL, et al. Bone Marrow Transplant. 2014;49(5):704-708. 7. Yoo EK, et al. J Invest Dermatol. 1996;107:235-242. 8. Morelli AE, et al. Blood. 2003;101:611-620. 9. Craciun LI, et al. Transplantation. 2002;74:995-1000. 10. Lamioni A, et al. Transplantation. 2005;79:846-850. 11. Knobler R, et al. J Eur Acad Dermatol Venereol. 2020;34(12):2693-2716. 12. Cho A, et al. Front Med (Lausanne). 2018;5:236. 13. Trautinger F, et al. Eur J Cancer. 2017;77:57-74. 14. Padmanabhan A, et al. J Clin Apher. 2019;34(3):171- 354. 15. Alfred A, et al. Br J Haematol. 2017;177:287-310. 16. Dignan FL, et al. Br J Haematol. 2012;158(1):30–45. 17. Pierelli L, et al. Transfusion. 2013;53(10):2340-2352. 18. Zeiser R. et al. Graft-versus-Host Erkrankung, akut. 2021. Available at: https://www.onkopedia.com/de/onkopedia/guidelines/graft-versus-host-erkrankung-akut/@@view/html/index.html. Accessed February 2022. 19. Costanzo MR, et al. J Heart Lung Transplant. 2010;29(8):914-956 20. Crespo C, et al. Clin Ther. 2012;34(8):1774-1787. 21. Walczak J, et al. Value Health. 2012;15:A349. 22. de Waure C, et al. Value Health. 2015;18(4):457-466. 23. Geskin L, Malone DC. J Dermatolog Treat. 2018;29(5):522-530. 24. Mayer W, et al. Retrospective data analysis related to the use of open and closed extracorporeal photopheresis systems. Presented at the 40th annual meeting of the American Society for Apheresis; 14-18 May, 2019, Portland, USA. Available at: https://doi.org/10.1002/jca.21704. Accessed November 2021. 25. Linic B, et al. The implementation of ‘lean’ working practices and THERAKOSTM CELLEXTM have resulted in a 50% increase in patient treatments with the same number of nurses employed in the unit. Presented at the 20th congress of the European Hematology Association; 11-14 June, 2015, Vienna, Austria. Poster E1428. 26. Therakos (UK) Ltd. Data on file - ref-05184. 27. Therakos (UK) Ltd. Data on file - ref-05185.

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Important Safety Information
For the TherakosTM Photopheresis
Procedure

Indications

The THERAKOSTM CELLEXTM Photopheresis System is indicated for the administration of photopheresis. Please refer to the appropriate product labelling for a complete list of warnings and precautions.

Contraindications

THERAKOSTM Photopheresis is contraindicated in:

  • Patients possessing a specific history of a light sensitive disease.
  • Patients who cannot tolerate extracorporeal volume loss or who have white blood cell counts greater than 25,000 / mm3.
  • Patients who have coagulation disorders or who have previously had a splenectomy.

Warnings and Precautions

THERAKOSTM 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. Safety in children has not been established.

  • Do not expose the device to a magnetic resonance (MR) environment. The device may present a risk of projectile injury, and thermal injury and burns may occur. The device may generate artifacts in the MR image, or may not function properly.
  • Thromboembolic events, including pulmonary embolism and deep vein thrombosis, have been reported in the treatment of Graft versus Host Disease (GvHD). Special attention to adequate anticoagulation is advised when treating patients with GvHD.
  • When prescribing and administering THERAKOSTM Photopheresis for patients receiving concomitant therapy, exercise caution when changing treatment schedules to avoid increased disease activity that may be caused by abrupt withdrawal of previous therapy.

Adverse Events

  • Hypotension may occur during any treatment involving extracorporeal circulation. Closely monitor the patient during the entire treatment for hypotension.
  • Transient pyretic reactions, 37.7–38.9°C (100–102°F), have been observed in some patients within six to eight hours of reinfusion of the photoactivated leukocyte-enriched blood. A temporary increase in erythroderma may accompany the pyretic reaction.
  • Treatment frequency exceeding labelling recommendations may result in anaemia.
  • Venous access carries a small risk of infection and pain.

Please refer to the THERAKOSTM CELLEXTM Photopheresis System Operator Manual for a complete list of warnings and precautions.

IMPORTANT SAFETY INFORMATION FOR METHOXSALEN USED IN CONJUNCTION WITH THERAKOSTM PHOTOPHERESIS

Contraindications

Methoxsalen is contraindicated in:

  • Patients exhibiting idiosyncratic or hypersensitivity reactions to methoxsalen, psoralen compounds, or any of the excipients
  • Patients with co-existing melanoma, basal cell or squamous cell skin carcinoma
  • Patients who are pregnant, and sexually active men and women of childbearing potential unless adequate contraception is used during treatment
  • Patients with aphakia because of the significantly increased risk of retinal damage due to the absence of a lens

Warnings and Precautions

  • Special care should be exercised in treating patients who are receiving concomitant therapy (either topically or systemically) with known photosensitizing agents.
  • Oral administration of methoxsalen followed by cutaneous UVA exposure (PUVA therapy) is carcinogenic.
  • Patients should be told emphatically to wear UVA absorbing, wrap-around sunglasses for twenty-four (24) hours after methoxsalen treatment. They should wear these glasses any time they are exposed to direct or indirect sunlight, whether they are outdoors or exposed through a window.
  • Safety in children has not been established.

Refer to the package insert for methoxsalen sterile solution (20 micrograms / mL) or the oral 8-methoxypsoralen dosage formulation for a list of all warnings and precautions.

Please refer to the THERAKOSTM CELLEXTM Photopheresis System Operator Manual for a complete list of warnings, precautions and adverse events.

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If you are a French resident, please visit www.therakos.fr

Applications for the 2022 EIA are now closed.
The 2022 ECP Immunomodulation Investigator Award has been awarded to Professor Andrew Fisher, Professor of Respiratory Transplant Medicine at Newcastle University, and Honorary Consultant Respiratory and Transplant Physician at The Newcastle upon Tyne Hospitals NHS Foundation Trust's Institute of Transplantation. The objective of his project is to perform an in depth mechanistic assessment of Extracorporeal Photopheresis (ECP) treatment in patients suffering from Chronic lung Allograft Dysfunction (CLAD).

Full details are available on our press release page.

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