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My Therakos

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Therakos e-learning platform

Prof Peter Jaksch

Expert:

Prof Peter Jaksch

Speciality:

Solid Organ Transplantation

Institution:

Medical University of Vienna

Bio:

I am working since more than 20 years in one the largest lung TX centres worldwide with more than 100 transplants performed per year. We build an excellent network with a lot of other TX centres (Europe, US and Asia) conducting an number of single and multicentre studies in the field of LuTX.

My main interest are clinical research projects dealing with immunosuppressive protocols, induction therapy, CLAD and immunomonitoring.

Since 20 years we are using ECP in our department in cooperation with the Depatment of dermatology (Prof R. Knobler) and Department of Blood Group Serology and Transfusion Medicine (Prof N. Worel) : main indication was CLAD/BOS but in the last 10 years more and more new ECP indictaions evolved like CNI sparing protocoles, use as induction therapy and treatment of donor specific antibodies.

Regarding educational projects in our lung TX centre:
Since 7 years we perform so called “TX academies” for pulmologists, surgeons, ICU doctors and other interested specialist about all aspects of lung transplantation with excellent acceptance.

In the last years we initiated a number of scientific projects with different LuTX centres in Europe (Hannover, Oslo, Leuven, Budapest, etc.) with led to some very interesting scientific papers (LuTX in pats after BMT, influence of use of antifibrotic drugs on postTX outcome, etc). This is for sure something what could and should be enforced.

Furthermore, cooperations with different countries is mandatory to establish better and pan-European registries and databases to have the chance to learn and improve outcomes in comparing different strategies and concepts.
Finally, I want to mention our PR work together with lung transplanted patients – we climbed successfully Mt Kilimanjaro together with 10 LuTX recipients which accompanied by 24 medical doctors, psychologists, nurses and friends. This track entailed a large number of TV and radio interviews, presentations on medical meetings and scientific papers. Furthermore, this event encouraged patients to accept lung transplantation as a treatment option.

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Important Safety Information
For the Therakos^TM 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.