Customer Support Services
THERAKOS® Photopheresis Customer Care team 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.
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 services 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
*Additional charges will apply for post-warranty on-site service. Contact a Customer Care representative for more information.
ECP, extracorporeal photopheresis.
Access to operator manuals and technical bulletins
Password-protected product documentation for customers with a CELLEX instrument at their institution.
INDICATIONS AND USAGE
UVADEX® (methoxsalen) Sterile Solution is indicated for extracorporeal administration with the THERAKOS® UVAR XTS® or 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 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
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. 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
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
Patients should be advised to avoid all exposure to sunlight during the 24 hours following photopheresis treatment
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
Instruct patients emphatically to wear UVA-absorbing, wrap-around sunglasses for 24 hours after UVADEX treatment
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.
IMPORTANT SAFETY INFORMATION
The THERAKOS UVAR XTS or THERAKOS CELLEX Photopheresis Systems are 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