Mallinckrodt is a global business that develops, manufactures, markets and distributes specialty pharmaceutical products and therapies. We are the only providers of integrated systems for the delivery of ECP Immunomodulation.
As such, we are pioneers and global leaders in ECP Immunomodulation, (an approach that employs the patient’s own immune cells to modulate dysregulated immune function[1-3]) with a well-established record of safety and clinical impact.[1,4,5] We are committed to supporting you in your efforts to enhance the safety and efficacy of ECP Immunomodulation by providing high quality products backed by world-class service and training and by pursuing additional approved indications.
Helping people take a more nurturing approach to the immune system in GvHD
THERAKOS ECP Immunomodulation™ enables you to nurture the patient’s immune system[6-8] in GvHD to achieve high response without suppressing immune function. [9-12] Watch our new video to discover the benefits of our distinct approach to treat GvHD.
THERAKOS™ Photopheresis systems are CE marked for the administration of photopheresis.
For the THERAKOS™ Photopheresis Procedure:
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.
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. 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.
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.
TO REPORT AN ADVERSE EVENT
Available from most countries in Europe, Middle East and Africa
Support en français:
+33 18 288 0867
Unterstützung auf Deutsch:
+49 32 221 093 619
Supporto in italiano:
+39 051 042 0666
800 149 844
Support in English:
+44 154 860 0009
Within the UK:
0808 238 6011
Asistencia en español:
+34 932 20 2094
Dentro de España:
800 600 798
Healthcare professionals, patients and caregivers play an important role in the reporting process of safety related information. To enable Mallinckrodt to provide the most up-to-date safety information on our products, your support is pivotal in our continued commitment to patient and drug safety.
Marshall SR. Nat Clin Pract Oncol. 2006 Jun;3(6):302-314.
Bruserud Ø, et al. Cancer Immunol Immunother. 2014;63(8):757-777.
Hart JW, et al. Ther Adv Hematol. 2013;4:320-334.
Knobler R, et al. J Eur Acad Dermatol Venereol. 2014;28(suppl 1):1-37.
Garnett C, et al. Ther Adv Hematol. 2013;4:366-378.
Craciun LI, et al. Transplantation. 2002;74:995-1000.
Peritt D. Biol Blood Marrow Transplant. 2006;12(1 Suppl 2):7-12.
Lamioni A, et al. Transplantation. 2005;79:846-850.
Greinix HT, et al. Haematologica. 2006;91:405-408.
Flowers ME, et al. Blood. 2008;112:2667-2674.
Dignan FL, et al. Bone Marrow Transplant. 2014;49:704-708.
Das-Gupta E, et al. Bone Marrow Transplant. 2014;49:1251-1258.