THERAKOS ECP Immunomodulation™

The THERAKOS™ Photopheresis platform is the worlds only approved, fully-integrated system for administering ECP Immunomodulation.  Our system is used by academic medical centres, hospitals and treatment centres in more than 30 countries and has delivered over one million treatments globally.
 
THERAKOS™ Photopheresis Systems are the only CE marked devices for the administration of ECP and the only FDA-approved systems for administering photopheresis.* 

CELLEX™ Photopheresis System
 

The CELLEX™ Photopheresis System, our latest-generation photopheresis platform, combines state-of-the-art cell collection, photoactivation, and reinfusion technologies in a single, integrated system. The fully-validated, automated system design allows for single-operator management of the photopheresis process intended to reduce the risks of infection, cross-contamination, and patient reinfusion errors.[1,2] In addition, with the CELLEX™ Photopheresis System an ECP treatment can be completed in approximately 90 minutes.[†3]

With its range of enhanced features, the CELLEX™ Photopheresis System helps connect the needs of clinicians, operators and managers to the needs of patients.


Minimised procedure time frees up hospital resources and the patient:

  • Single-cycle buffy coat optimises treatment fluids, leading to reduced photoactivation time

  • Option of double-needle access shortens procedure time compared with single-needle access[3]

Optimised procedure for procedural confidence and patient comfort

  • Patient remains connected throughout, maximising sterility and eliminating the risk of improper reinfusion

  • Ability to switch between double- and single-needle access at any time based on venous access conditions

  • Automated 8-MOP dosage and photoactivation time calculations for operator ease of use

  • Bowl Optic Sensor enables customising the system for abnormal plasma conditions (e.g. abnormal lipid or bilirubin levels)

  • State-of-the-art user interface to easily monitor and adjust procedural parameters to ensure the best conditions for the patient

  • Integrated alerts and troubleshooting allows operators to respond rapidly and accurately to changes in procedural status

  • Improved fluid balance management and double-needle mode minimises extracorporeal volume and fluid shifts[‡3]
    – making CELLEX™ suitable for patients with haemodynamic instability, low body weight or compromised cardiac, pulmonary or renal function

  • Peristatic pumps provide smooth vein pressure, maximising patient comfort

New CELLEX™ PLUS System Upgrade


As part of our ongoing commitment to improve our technology according to your evolving needs, we are now introducing a new System upgrade called “PLUS”. With this upgrade, both operators and patients may benefit from a quieter, more continuous treatment experience with fewer interruptions.

  • A new system of automatic flow rate controls has been introduced to reduce unnecessary operator interventions

  • With the new blood prime feature, portions of the blood prime procedure are automated reducing the burden on operators

  • Additional system checks during prime have been introduced to minimise the risk of alarms and procedure interruptions

  • Enhancements on the user interface aim to improve operator interactions

  • To personalise fluid balance management, we have added automated fluid-balance calculations as well as a fluid balance reset control 
     

For the THERAKOS™ Photopheresis Procedure:


Indications
The THERAKOS™ UVAR XTS™ and THERAKOS™ CELLEX™ Photopheresis Systems are indicated for the administration of photopheresis. Please refer to the appropriate product labelling for a complete list of warnings and precautions.

Contraindications
THERAKOS™ Photopheresis is contraindicated in patients possessing a specific history of a light sensitive disease. THERAKOS™ Photopheresis is contraindicated in patients who cannot tolerate extracorporeal volume loss or who have white blood cell counts greater than 25,000 mm[3]. THERAKOS™ Photopheresis is contraindicated in patients who have coagulation disorders or who have previously had a splenectomy.

Warnings and Precautions
THERAKOS™ 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.

Both men and women should take adequate contraceptive precautions both during and after completion of photopheresis 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 appropriate product labelling for a complete list of warnings and precautions.

Therakos CellEx Thumbnail.png
Click the link below to view in another language
THERAKOS™ CELLEX™ PHOTOPHEREIS PROCEDURAL VIDEO
THERAKOS™ ECP IMMUNOMODULATION™ PROPOSED MOA VIDEO
Therakos-ECP-Immunomodulation.jpg

*For the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma [CTCL] in persons who have not been responsive to other forms of treatment.[4] CTCL is characterised by malignant T cells that become activated, achieve clonal dominance, and accumulate in the skin, lymph nodes, and peripheral blood.[5,6]
†With dual-needle access. With single-needle access, treatment time may be approximately 100 minutes.[3]
‡Compared to single-needle mode.

  1. Knobler R, et al. J Eur Acad Dermatol Venereol. 2014;28 Suppl 1:1-37.

  2. Perotti C, Sniecinski I. Transfus Apher Sci. 2015;52(3):360-368.

  3. Bisaccia E, et al. Br J Dermatol. 2009;161(1):167-169.

  4. UVADEX® (methoxsalen) Sterile Solution [package insert]. 3 Lotus Park, The Causeway, Staines, Surrey, TW18 3AG, UK

  5. Girardi M, et al. N Engl J Med. 2004; 350: 1978–1988;

  6. Kim EJ, et al. J Clin Invest. 2005; 115: 798–812.

 

 

Mallinckrodt, the 'M' brand mark, the Mallinckrodt Pharmaceuticals logo and other brands are trademarks of a Mallinckrodt company.

 

© 2018 Mallinckrodt. Mallinckrodt Pharmaceuticals is a registered business name of Mallinckrodt plc, which is registered in Ireland as a public limited company with registration number 522227 and has its registered office at Damastown, Mulhuddart, Dublin 15, Ireland.