Partnerships

Enhanced Partnership with GITMO

We are thrilled to announce the elevation of our partnership with GITMO, a cornerstone in the Bone Marrow Transplantation field. This collaboration not only elevates our reputation but also expands the clinical insights into the utilisation of Therakos ECP Immunomodulation in the GvHD treatment algorithm.

We are confident that this reinforced partnership with GITMO will drive advancements in Bone Marrow Transplantation and further our mission to serve the medical and patients' communities.

Key Highlights:

Webinar Collaboration: We are supporting a webinar facilitated by GITMO that will focus on "Therakos ECP Immunomodulation in Combinational Therapy Approaches in GvHD Treatment."

Patient Case Discussion Platform: We are introducing a dedicated platform for discussions of patient cases. This initiative, led by a committee of GITMO experts, invites participation from all Italian hospitals and GITMO members.

Educational Endeavors: GITMO has graciously agreed to promote Mallinckrodt's educational activities, ensuring that our valuable insights reach the broader medical community.

Strengthened Alliance with ESOT

We are honored to announce the strengthening of our strategic partnership with ESOT (European Society of Solid Organ Transplantation). This collaboration underscores our mutual commitment to advancing scientific knowledge and education in the realm of Solid Organ Transplantation (SOT).

Key Objectives: Foster discussions centered on the latest scientific advancements and therapeutic strategies, with a particular focus on Therakos ECP immunomodulation.

Strategic Initiatives

Survey Initiative: A comprehensive survey targeting all International institutions to gain insights into the prevailing standard of care.

Main outcomes are:

Webinars: Two webinars aimed at disseminating knowledge and fostering dialogue.
Workshops: Five specialized workshops addressing critical topics within the SOT domain.
Expert Forum: A platform for thought leaders to discuss and deliberate on pressing new challenges in the field of Solid Organ Transplants.
Masterclass: An intensive session dedicated to in-depth learning and expertise sharing.

ESOT/ETPO Alliance Collaboration: Engaging discussions to enhance awareness and education for SOT patients.

Patient Education Resources: Dedicated materials to empower and inform SOT patients.

All the aforementioned projects will be spearheaded by a distinguished group of experts, appointed by the ESOT Board. We remain steadfast in our commitment to excellence and look forward to the positive outcomes this collaboration with ESOT will yield.

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.