Company

Pioneering ECP Immunomodulation for over 30 years

Therakos is a specialty brand of Mallinckrodt – a global business that develops, manufactures, markets and distributes specialty pharmaceutical products and therapies.

For over 30 years, we have played a pioneering role in advancing the science of immunotherapy delivered through ECP. We continue to invest in the highest standards of medical education, while seeking to refine our technologies, and remaining dedicated to furthering advances in ECP Immunomodulation.

Our THERAKOS^TM CELLEX^TM Photopheresis System is the only fully integrated and validated system for the delivery of ECP.¹

We strive to provide innovative therapeutic platforms and comprehensive support services to help healthcare professionals deliver optimised ECP Immunomodulation to patients.

We are dedicated to helping improve patients’ lives. That’s why we offer a comprehensive range of support services to healthcare professionals to help them feel more confident in delivering ECP Immunomodulation to their patients.

Dedicated to the practice and technological advancement of ECP for over 30 years

In 1987, we pioneered ECP treatment with the launch of our unique and innovative THERAKOS^TMUVAR XTS^TMSystem, which gained FDA approval the following year. Since then, we have been the only providers of fully integrated and validated ECP systems.

Our current platform, the THERAKOS^TM CELLEX^TMPhotopheresis System, first arrived in 2009. It has since been used to deliver over 1 million treatments and is used in over 300 treatment centres across 30 countries.²

Technological advancements from 1987 to today

The evolution of our integrated ECP
Immunomodulation platforms

Our Offer

Beyond the THERAKOS^TMCELLEX^TM Photopheresis System, we offer a range of support services to help enable healthcare professionals deliver optimised ECP Immunomodulation to patients.

Education And Knowledge Sharing

Our education and knowledge sharing, delivered through the Therakos Institute, is a valuable tool to healthcare professionals. It provides high-quality professional education provided by leading clinicians, scientific advisors and nurse trainers.

Patient and Funding Access

We offer patient and funding access support through a number of different initiatives. This helps us to advance the knowledge and clinical practice of ECP Immunomodulation for future generations.

Scientific and Clinical Partnerships

Through ourscientific and clinical partnerships, we strive to maintain the highest possible standards – uniting with leading figures across the world to ensure we provide the strongest possible service.

Comprehensive Customer Support

A key part of our service is providingcomprehensive customer support. Our aim is to help front-line users feel confident in delivering ECP Immunomodulation treatment to patients.

ECP, extracorporeal photopheresis; FDA, Food and Drug Administration.

References:

1.Knobler R, et al. J Eur Acad Dermatol Venereol. 2020;34(12):2693-2716.2.Therakos (UK) Ltd. Data on File – ref-05174.

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.

Company

Pioneering ECP Immunomodulation for over 30 years

Dedicated to the practice and technological advancement of ECP for over 30 years

Technological advancements from 1987 to today

Our Offer

Education And Knowledge Sharing

Patient and Funding Access

Scientific and Clinical Partnerships

Comprehensive Customer Support

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THERAKOS™ CELLEX™ Photopheresis System

THERAKOS ECP Immunomodulation™

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IMPORTANT SAFETY INFORMATION FOR THE THERAKOS™ PHOTOPHERESIS PROCEDURE

IMPORTANT SAFETY INFORMATION FOR METHOXSALEN USED IN CONJUNCTION WITH THERAKOSTM PHOTOPHERESIS

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