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Important Safety Information
For the TherakosTM Photopheresis
The THERAKOSTM CELLEXTM Photopheresis System is indicated for the administration of photopheresis. Please refer to the appropriate product labelling for a complete list of warnings and precautions.
THERAKOSTM 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
THERAKOSTM 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 THERAKOSTM 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.
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 THERAKOSTM CELLEXTM Photopheresis System Operator Manual for a complete list of warnings and precautions.
IMPORTANT SAFETY INFORMATION FOR METHOXSALEN USED IN CONJUNCTION WITH THERAKOSTM PHOTOPHERESIS
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 THERAKOSTM CELLEXTM Photopheresis System Operator Manual for a complete list of warnings, precautions and adverse events.
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Applications for the 2022 EIA are now closed.
The 2022 ECP Immunomodulation Investigator Award has been awarded to Professor Andrew Fisher, Professor of Respiratory Transplant Medicine at Newcastle University, and Honorary Consultant Respiratory and Transplant Physician at The Newcastle upon Tyne Hospitals NHS Foundation Trust's Institute of Transplantation. The objective of his project is to perform an in depth mechanistic assessment of Extracorporeal Photopheresis (ECP) treatment in patients suffering from Chronic lung Allograft Dysfunction (CLAD).
Full details are available on our press release page.
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