THERAKOS™ CELLEX™ Photopheresis System

The THERAKOS™ CELLEX™ Photopheresis System has received CE Certification under the European Union Medical Device Regulation (EU MDR)

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Welcome to the home of ECP. With over 30 years of pioneering innovation.

THERAKOS is the pioneer and global leader in extracorporeal photopheresis (ECP), with over 30 years of experience advancing this innovative therapy. Discover how our expertise, technology and commitment to innovation are helping transform care for patients with immune-mediated diseases.

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Healthcare Professionals

Learn about THERAKOS ECP Immunomodulation™, including its proposed mechanism of action and clinical applications. Discover the CELLEX™ system and the full range of services we offer to HCPs.

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Patients and Caregivers

Find out more about ECP, how it works, and what to expect before starting treatment. Hear from patients who have undergone the procedure and find answers to frequently asked questions.

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Discover our CELLEX™ System

THERAKOS™ CELLEX™ Photopheresis System, the world’s only fully integrated  and validated ECP system.

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Harness their natural strength^1,2

Our patients are the inspiration behind everything we do
THERAKOS ECP Immunomodulation™ employs the patient's own immune cells to modulate disregulated immune function^1-9.
The mechanisms by which ECP exerts its clinical effects are under continual investigation to be more fully understood.

1. Therakos Operator’s Manual. THERAKOS® CELLEX® Photopheresis System. 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. Yoo EK, et al. J Invest Dermatol. 1996;107:235-242. 7. Morelli AE,  et al. Blood. 2003;101:611-620. 8. Craciun LI, et al. Transplantation. 2002;74:995-1000. 9. Lamioni A, et al. Transplantation. 2005;79:846-850.

IMPORTANT SAFETY INFORMATION FOR THE THERAKOS™ PHOTOPHERESIS PROCEDURE

Indications

The THERAKOS™ CELLEX™ Photopheresis System is indicated for patients older than 18 years of age for the administration of photopheresis in the following:

Cutaneous T Cell Lymphoma (CTCL)
Solid Organ Transplant Rejection (SOT) (heart, lung)

The THERAKOS™ CELLEX™ Photopheresis System is indicated in patients older than 3 years of age for the management of:

Acute and Chronic Graft versus Host Disease (aGvHD, cGvHD)

Contraindications

THERAKOS^TM 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

THERAKOS^TMPhotopheresis 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.

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 THERAKOS 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.

IMPORTANT SAFETY INFORMATION FOR METHOXSALEN USED IN CONJUNCTION WITH THERAKOS^TM PHOTOPHERESIS

Consult the 8-methoxypsoralen (Methoxsalen (20 micrograms / mL)) professional leaflet or the oral 8-methoxypsoralen formulation package insert before prescribing or dispensing any medication.

Warnings and Precautions

Patients exhibiting multiple basal cell carcinomas or having a history of basal cell carcinoma should be diligently observed and treated.
Methoxsalen may cause fetal harm when given to a pregnant woman. Women undergoing photopheresis should be advised to avoid becoming pregnant.
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.

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.

THERAKOS™ CELLEX™ Photopheresis System

The THERAKOS™ CELLEX™ Photopheresis System has received CE Certification under the European Union Medical Device Regulation (EU MDR)

Pioneering ECP Immunomodulation for over 35 years

Discover more about the pioneers of ECP Immunomodulation

Ask the Expert

Book your Ask the Expert session today

Therakos Institute

Discover our full educational offer including Educational Courses – Centres of Excellence, Webinars, Speaker Meetings and more

Register Now

Get access to the Therakos Institute, e-learning platform and myTherakos to keep up to date with Therakos ECP ImmunomodulationTM

Therakos Institute

Follow us on and stay up to date with the latest news and events in ECP Education

Welcome to the home of ECP

Welcome to the home of ECP. With over 30 years of pioneering innovation.

Healthcare Professionals

Patients and Caregivers

Therakos Institute

Discover our CELLEX™ System

Harness their natural strength1,2

You are leaving the Therakos.eu website.

IMPORTANT SAFETY INFORMATION FOR THE THERAKOS™ PHOTOPHERESIS PROCEDURE

IMPORTANT SAFETY INFORMATION FOR METHOXSALEN USED IN CONJUNCTION WITH THERAKOSTM PHOTOPHERESIS

Get access to the Therakos Institute, e-learning platform and myTherakos to keep up to date with Therakos ECP Immunomodulation^TM

Harness their natural strength^1,2

IMPORTANT SAFETY INFORMATION FOR METHOXSALEN USED IN CONJUNCTION WITH THERAKOS^TM PHOTOPHERESIS