In-Office Materials
CELLEX Overview Brochure

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Description of the technological features that help make the CELLEX instrument a state-of-the-art innovation in extracorporeal photopheresis (ECP)
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Overview of the buffy coat harvesting process
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Detailed instrument diagram
Total Care Overview Brochure

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Overview of all the services available within THERAKOS Total Care support
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Summary of support resources available from Mallinckrodt
Reimbursement Reference Guide

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Billing and coding information for the THERAKOS® Photopheresis procedure*
*You are ultimately responsible for determining the appropriate reimbursement processes and billing codes.
THERAKOS Photopheresis Dosing and Titration Guide

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A quick reference guide for the 2 treatment and assessment schedules
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Graphics outline standard and accelerated treatment
Treatment Center Directory

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Listing of treatment centers offering THERAKOS Photopheresis
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PDF is current as of August 2019

For Operator’s Manuals or product certifications, please log in to the MyTHERAKOS portal
Find a THERAKOS Photopheresis Treatment Center Near You
To search for a center near you that provides ECP, please visit the patient website.
You can also download the THERAKOS Extracorporeal Photopheresis Treatment Center Directory
Treatment centers are independent, third-party facilities not owned, operated, or controlled by Mallinckrodt. This resource is provided for informational use only and may not be comprehensive.
INDICATIONS AND USAGE
UVADEX® (methoxsalen) Sterile Solution is indicated for extracorporeal administration with the THERAKOS® CELLEX® Photopheresis System in the palliative treatment of the skin manifestations of Cutaneous T-Cell Lymphoma (CTCL) that is unresponsive to other forms of treatment.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
UVADEX is contraindicated in patients exhibiting idiosyncratic or hypersensitivity reactions to methoxsalen, other psoralen compounds, or any of the excipients. Patients possessing a specific history of a light-sensitive disease state should not initiate methoxsalen therapy.
Diseases associated with photosensitivity include lupus erythematosus, porphyria cutanea tarda, erythropoietic protoporphyria, variegate porphyria, xeroderma pigmentosum, and albinism.
UVADEX is contraindicated in patients with aphakia because of the significantly increased risk of retinal damage due to the absence of lenses.
Patients should not receive UVADEX if they have any contraindications to the photopheresis procedure.
WARNINGS AND PRECAUTIONS
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Patients who are receiving concomitant therapy (either topically or systemically) with known photosensitizing agents such as anthralin, coal tar or coal tar derivatives, griseofulvin, phenothiazines, nalidixic acid, halogenated salicylanilides (bacteriostatic soaps), sulfonamides, tetracyclines, thiazides, and certain organic staining dyes such as methylene blue, toluidine blue, rose bengal, and methyl orange may be at greater risk for photosensitivity reactions with UVADEX
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Oral administration of methoxsalen followed by cutaneous UVA exposure (PUVA therapy) is carcinogenic. Methoxsalen also causes DNA damage, interstrand cross-links and errors in DNA repair
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Methoxsalen may cause fetal harm when given to a pregnant woman. There are no adequate and well-controlled studies of methoxsalen in pregnant women. If UVADEX is used during pregnancy, or if the patient becomes pregnant while receiving UVADEX, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant. It is not known whether this drug is excreted in human milk
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After methoxsalen administration, exposure to sunlight and/or ultraviolet radiation may result in "premature aging" of the skin
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Since oral psoralens may increase the risk of skin cancers, monitor closely those patients who exhibit multiple basal cell carcinomas or who have a history of basal cell carcinomas
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Serious burns from either UVA or sunlight (even through window glass) can result if the recommended dosage of methoxsalen is exceeded or precautions are not followed
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Patients should be advised to avoid all exposure to sunlight during the 24 hours following photopheresis treatment
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Exposure to large doses of UVA light causes cataracts in animals. Oral methoxsalen exacerbates this toxicity. Serum methoxsalen concentrations are substantially lower after extracorporeal UVADEX treatment than after oral methoxsalen treatment. Nevertheless, if the lens is exposed to UVA light while methoxsalen is present, photoactivation of the drug may cause adducts to bind to biomolecules within the lens
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Instruct patients emphatically to wear UVA-absorbing, wrap-around sunglasses for 24 hours after UVADEX treatment
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Safety in children has not been established
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Thromboembolic events, such as pulmonary embolism and deep vein thrombosis, have been reported with UVADEX administration through photopheresis systems for treatment of patients with graft-versus-host disease, a disease for which UVADEX is not approved.
ADVERSE REACTIONS
INDICATIONS
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
The THERAKOS CELLEX Photopheresis System is not designated, sold, or intended for use except as indicated.
Certain underlying medical conditions contraindicate THERAKOS Photopheresis, including patients:
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who cannot tolerate extracorporeal volume loss during the leukocyte-enrichment phase
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exhibiting idiosyncratic or hypersensitivity reactions to 8-methoxypsoralen/psoralen compounds
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with coagulation disorders
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who have had previous splenectomy
WARNINGS AND PRECAUTIONS
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THERAKOS 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
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Patients who may not be able to tolerate the fluid changes associated with extracorporeal photopheresis should be monitored carefully
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Procedures, such as renal dialysis, which might cause significant fluid changes (and expose the patient to additional anticoagulation) should not be performed on the same day as extracorporeal photopheresis
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Individual patients may require a heparin dosage that varies from the recommended dose to prevent post-treatment bleeding or clotting during a treatment
ADVERSE REACTIONS
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Hypotension may occur during any treatment involving extracorporeal circulation. Closely monitor the patient during the entire treatment for hypotension
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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
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Treatment frequency exceeding labeling recommendations may result in anemia
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Venous access carries a small risk of infection and pain