Mallinckrodt Announces Study Demonstrating Effectiveness of ECP Immunomodulation, as an adjunct to local standard therapy, in Treatment of Lung Transplant Patients with Bronchiolitis Obliterans Syndrome (BOS) - Seite 2

The presentation abstract can be viewed here.

Mallinckrodt is the world's only provider of approved, fully-integrated systems for administering immunomodulatory therapy through ECP. Its Therakos therapeutic platforms, including the latest generation THERAKOS CELLEX Photopheresis System, are used by academic medical centres, hospitals, and treatment centres in nearly 40 countries and have delivered more than 1 million treatments globally. For more information, please visit www.therakos.co.uk.

UVAR XTS and THERAKOS CELLEX Photopheresis Systems are approved in a number of global markets, including Europe, for the administration of photopheresis. Please refer to your local approved labelling for more information on approved uses for specific therapeutic areas.

Important Safety Information for the THERAKOS^TM 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 mm³. 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.