EIA Terms and Conditions

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Advancing ECP Immunomodulation Investigator Award in Graft versus host disease:
Refining THERAKOS ECP Immunomodulation™

Terms and Conditions

The following terms and conditions apply:

Submissions must demonstrate a significant focus on investigating the mechanisms behind THERAKOS ECP Immunomodulation™ in the field of Graft versus Host disease.
As part of the application process, applicants are required to provide a detailed outline of their plans for the grant funding according to the above-mentioned criteria. The provided template might serve as a guide for your application, but other formats are acceptable as well.
Applications without a detailed budget justification will not be accepted.
Project proposal must not only demonstrate a reasonable and detailed budget but also feasibility within a timeline of 18 months.
All submissions must be in English.
The winner must complete and sign the grant contract within an agreed timeline after selection. Failure to execute the contract in a timely manner may result in default of the award, in which case the runner-up would receive the award.
Projects are expected to be completed within 18 months following the distribution of funds.
Awardees are not nominated nor selected as an inducement or reward for purchasing, prescribing, using or recommending Mallinckrodt products.
Details of the award will also be declared in line with Transparency Reporting requirements.

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.

EIA Terms and Conditions

Advancing ECP Immunomodulation Investigator Award in Graft versus host disease:Refining THERAKOS ECP Immunomodulation™

Terms and Conditions

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IMPORTANT SAFETY INFORMATION FOR THE THERAKOS™ PHOTOPHERESIS PROCEDURE

IMPORTANT SAFETY INFORMATION FOR METHOXSALEN USED IN CONJUNCTION WITH THERAKOSTM PHOTOPHERESIS

Advancing ECP Immunomodulation Investigator Award in Graft versus host disease:
Refining THERAKOS ECP Immunomodulation™

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