Where passion becomes expertise™
The THERAKOS INSTITUTETM (also known as TI) brings together innovative learning programs and passionate individuals to help build a community of expert THERAKOS Photopheresis operators.
The THERAKOS INSTITUTE is designed to help facilitate the understanding of the photopheresis procedure through stimulating learning experiences. These hands-on skill enrichment programs help drive community knowledge sharing that is intended to help elevate the photopheresis experience.
Innovative digital learning platform
Personalized instruction at your facility
Learning laboratory skill center
NOTE: The educational material located at TI Online is not intended to constitute complete instruction on performing a procedure. Before independently operating the THERAKOS® CELLEX® Photopheresis System Instrument, Operators should, at a minimum, receive training from a THERAKOS Clinical Specialist that is beyond the information contained in the educational material; consult the Operator’s Manual, Reference Guides, and UVADEX® (methoxsalen) Sterile Solution package insert; and use their own clinical judgement when performing procedures. It is ultimately the facility’s responsibility to determine if an operator is qualified to use the device.
Call the THERAKOS Customer Care Team at 877-566-9466 or visit this page for more information about THERAKOS INSTITUTE Onsite or THERAKOS INSTITUTE OnPoint.
Access to operator manuals and technical bulletins
Password-protected product documentation for customers with a CELLEX System Instrument at their institution.
Customer Support Services
THERAKOS® Total Care is available 24 hours a day, 7 days a week
Customer Care representatives are available to help answer questions you may have
For general inquiries, orders, or to report a complaint, your first point of contact is our team of dedicated Customer Care representatives. They will be familiar with your account and can get you the help you may need. The toll-free phone number to reach this multilingual team is 1-877-566-9466.
As a CELLEX® System customer, you have complimentary access to the following services, with the exception of post-warranty on-site technical services, which are available for an incremental charge.
Your consistent point of contact
People familiar with your account are available to help you 24/7/365
For operator training
Personalized attention from clinical specialists with on-site instruction as needed
For instrument service and maintenance
Responsive field engineers handle regular preventive maintenance and service requests
For procurement and cost-center needs
Dedicated team to help support the contract process
For questions related to the THERAKOS Photopheresis System
Providing access to product information through live, professional phone support
To report a side effect/adverse drug experience or quality complaint:
Call Mallinckrodt at 1-877-566-9466, 24 hours a day, 7 days a week, or email TherakosCustomerCare@mnk.com.
*Additional charges will apply for post-warranty on-site service. Contact a Customer Care representative for more information.
Contact a THERAKOS Business Manager
THERAKOS Business Managers (TBMs) are prepared to help you find answers to questions regarding information on this website.
Request a meeting and someone will be in touch to schedule an appointment that works with your schedule.
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
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, including lupus erythematosus, porphyria cutanea tarda, erythropoietic protoporphyria, variegate porphyria, xeroderma pigmentosum, and albinism
Patients with aphakia because of significantly increased risk of retinal damage
Patients that have contraindications to the photopheresis procedure
WARNINGS AND PRECAUTIONS
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
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
Methoxsalen may cause fetal harm when given to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant. 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
Severe photosensitivity can occur in patients treated with UVADEX. Advise patients to wear UVA absorbing, wrap-around sunglasses and cover exposed skin or use a sunblock (SPF 15 or higher), and avoid all exposure to sunlight for twenty-four (24) hours following photopheresis treatment
After methoxsalen administration, exposure to sunlight and/or ultraviolet radiation may result in "premature aging" of the skin
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
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
Exposure to large doses of UVA light causes cataracts in animals. Oral methoxsalen exacerbates this toxicity
Safety in children has not been established
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
Side effects of photopheresis (UVADEX used with the THERAKOS Photopheresis Systems) were primarily related to hypotension secondary to changes in extracorporeal volume (>1%)
IMPORTANT SAFETY INFORMATION
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:
who cannot tolerate extracorporeal volume loss during the leukocyte-enrichment phase
exhibiting idiosyncratic or hypersensitivity reactions to 8-methoxypsoralen/psoralen compounds
with coagulation disorders
who have had previous splenectomy
WARNINGS AND PRECAUTIONS
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
Patients who may not be able to tolerate the fluid changes associated with extracorporeal photopheresis should be monitored carefully
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
Individual patients may require a heparin dosage that varies from the recommended dose to prevent post-treatment bleeding or clotting during a treatment
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 labeling recommendations may result in anemia
Venous access carries a small risk of infection and pain