THERAKOS™ CELLEX™ Photopheresis System Operating Room Course

The Goal

The goal of this practical course is to provide state of the art guidance, tips and best practices on the use of the THERAKOS CELLEX™ Photopheresis System. The interactive setting encourages sharing best practice and discussions between peers.

Agenda

Download Agenda PDF

Day 1 - 26 September 2024

08.00 – 16.00
Interactive workshop with a visit to the ECP unit

• Welcome and introduction

• THERAKOS™ CELLEX™ Photopheresis System device overview

• ECP device set-up and treatment: THERAKOS™ CELLEX™ Photopheresis System set up and checks

• ECP Treatment overview

• Alarms and troubleshooting

• Q&A

Day 2 - 27 September 2024

08.00 – 14.00

• Sharing best practice

– Venous access management
– Patient monitoring

• Q&A

• Final remarks and close

ECP: Extracorporeal Photopheresis

Please see the THERAKOS™ CELLEX™ Photopheresis System Operator Manual for indication,
contraindications, warning, precautions and adverse events.

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

Dr Wolfgang Mayer

Senior Medical Officer, Director of the Institute’s outpatient department, Tirol Kliniken GmbH

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™ CELLEX™ Photopheresis System is indicated for patients older than 18 years of age for the administration of photopheresis in the following:

Cutaneous T Cell Lymphoma (CTCL)
Solid Organ Transplant Rejection (SOT) (heart, lung)

The THERAKOS™ CELLEX™ Photopheresis System is indicated in patients older than 3 years of age for the management of:

Acute and Chronic Graft versus Host Disease (aGvHD, cGvHD)

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^TMPhotopheresis 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.

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 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.

IMPORTANT SAFETY INFORMATION FOR METHOXSALEN USED IN CONJUNCTION WITH THERAKOS^TM PHOTOPHERESIS

Consult the 8-methoxypsoralen (Methoxsalen (20 micrograms / mL)) professional leaflet or the oral 8-methoxypsoralen formulation package insert before prescribing or dispensing any medication.

Warnings and Precautions

Patients exhibiting multiple basal cell carcinomas or having a history of basal cell carcinoma should be diligently observed and treated.
Methoxsalen may cause fetal harm when given to a pregnant woman. Women undergoing photopheresis should be advised to avoid becoming pregnant.
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.

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.

THERAKOS™ CELLEX™ Photopheresis System Operating Room Course

The Goal

Agenda

Day 1 - 26 September 2024

Day 2 - 27 September 2024

Hosted by

Brought to you by the Therakos Institute

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