Celebrating 30 years of
Therakos ECP Immunomodulation^TM for GvHD patients

Discover More

Welcome to the home of ECP

Discover more about the pioneers of ECP Immunomodulation

Ask the Expert

Book your Ask the Expert session today

Learn more

Therakos Institute

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

Learn more

Register Now

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

Learn more

Therakos Institute

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

Introducing the Therakos Institute

Your educational platform to advance knowledge and understanding around ECP immunomodulation.

DISCOVER MORE

Find out more about our

Upcoming Webinars

DISCOVER MORE

Find out more about our

Educational Courses

DISCOVER MORE

Book an Ask the Expert session

DISCOVER MORE

Our

On Demand Webinars

DISCOVER MORE

Find out more about our

Upcoming Events

Discover More

Discover our CELLEX™ System

The world’s only fully integrated and validated ECP system

DISCOVER MORE

Our Legacy

We are the pioneers of ECP, and have been for over 30 years.

Discover more

Healthcare Professionals

Find out about our full range of services tailored to you.

DISCOVER MORE

Patients and Caregivers

Discover more about extracorporeal photopheresis and see our patient support materials.

DISCOVER MORE

Upcoming Congresses

IMPORTANT SAFETY INFORMATION FOR THE THERAKOS™ PHOTOPHERESIS PROCEDURE

Indications

The THERAKOS^TM CELLEX^TM 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

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^TM 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 THERAKOS^TM 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 THERAKOS^TM CELLEX^TM Photopheresis System Operator Manual for a complete list of warnings and precautions.

IMPORTANT SAFETY INFORMATION FOR METHOXSALEN USED IN CONJUNCTION WITH THERAKOS^TM 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 THERAKOS^TM CELLEX^TMPhotopheresis System Operator Manual for a complete list of warnings, precautions and adverse events.

Celebrating 30 years of Therakos ECP ImmunomodulationTM for GvHD patients

Welcome to the home of ECP

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

Introducing the Therakos Institute

Discover our CELLEX™ System

Our Legacy

Healthcare Professionals

Patients and Caregivers

Upcoming Congresses

Welcome to the Home of ECP

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

Celebrating 30 years of
Therakos ECP Immunomodulation^TM for GvHD patients

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

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