Educational Course on GvHD

The Goal

The goal of the GvHD interactive course is to provide a holistic approach and the latest information on the GvHD treatments using ECP therapy and foster discussion between peers.

Agenda

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Day 1 - 20 March 2024

Arrival of participants

20:00 – 20:15
Meeting at hotel lobby

20:15
Dinner with the faculty

Day 2 - 21 March 2024

09:00 – 09:30
Welcome & ECP overview introduction- Prof Robert Knobler

09:30 – 10:00
Achieving immune tolerance in GvHD - Prof Thomas Wekerle

10:00 – 10:30
Extracorporeal Photopheresis, proposed mechanism of immunomodulation - Medical Affairs, Mallinckrodt

10:30 – 10:40
Interactive discussion

10:40 – 10:55
Coffee break

10:55 – 11:25
Acute GvHD: the role of ECP - Prof Hildegard Greinix
• Patient selection for ECP treatment
• Treatment schedule

11:25 – 11:45
Break

11:45 – 12:15
Acute GvHD: the role of ECP - Prof Hildegard Greinix
• Response assessment
• Steroid / immunosuppressant tapering

12:15 – 12:25
Interactive discussion

12:25 – 13:25
Lunch

13:25 – 13:55
NIH diagnostic criteria for chronic GvHD - Prof Hildegard Greinix
• NIH Consensus on diagnostic and scoring
• Patient selection for ECP therapy based on organ involvement – the Vienna experience

13:55 – 14:10
Coffee break

14:10 – 14:50
NIH diagnostic criteria for chronic GvHD - Prof Hildegard Greinix
• Treatment schedule
• Response assessment including change of co-medication especially steroid / immunosuppressant taper

14:50 – 15:00
Interactive discussion

15:00 – 15:40
Procedural aspects of ECP in GvHD – the Vienna experience - Prof Nina Worel

15:40 – 16:00
Patient cases discussion - All

16:00 – 16:15
Final discussion, remarks and close

GvHD: Graft versus Host Disease, ECP: Extracorporeal Photopheresis, NIH: National Institutes of Health

For this course, participants are required to submit one patient case for discussion 15 days in advance of the session.

All speakers are subject to contract.
This is a commercial programme run by Therakos (UK) Ltd, part of Mallinckrodt Pharmaceuticals
This information is not intended for healthcare professionals based in the US and Canada.

Hosted by

Prof Robert Knobler

Associate Professor of Dermatology, Department of Dermatology, Division for Special & Environmental Dermatology, Medical University of Vienna

Brought to you by the Therakos Institute

This is a commercial programme run by Therakos (UK) Ltd, part of Mallinckrodt Pharmaceuticals

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IMPORTANT SAFETY INFORMATION FOR THE THERAKOS™ 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.

Educational Course on GvHD

The Goal

Agenda

Day 1 - 20 March 2024

Day 2 - 21 March 2024

Hosted by

Brought to you by the Therakos Institute

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