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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.

Prescribing Extracorporeal Photopheresis (ECP) to Treat CTCL Skin Symptoms in Patients Unresponsive to Other Forms of Treatment

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Cutaneous T-cell lymphoma (CTCL) is a rare, chronic disease characterized by burdensome skin symptoms2

In the United States, CTCLs constitute 71% of all primary cutaneous lymphomas3,4
The most common types of CTCL are MF (60%) and SS (5%).2

Mycosis Fungoides Thumb

Mycosis fungoides (MF)

  • Generally a more indolent form of CTCL that usually stays confined to the skin5,6

  • Characterized by a variety of skin manifestations, including scaly patches, plaques, and nodular lesions2,6

  • Lesions are often morphologically similar to other inflammatory conditions (eg, eczema, psoriasis) and, together with the slow progression of the disease, can contribute to delayed diagnosis and treatment6

Sézary Syndrome Thumb

Sézary syndrome (SS)

  • Patients typically present with erythroderma (>80% BSA), itching, and enlarged lymph nodes5

  • Commonly characterized by severe itching7

  • Tends to progress more rapidly than MF and has a worse prognosis7

Patients may experience a long series of different treatments5,8
Most patients with skin manifestations of CTCL experience slower progression of their underlying disease than patients with other forms of non-Hodgkin lymphoma (NHL) and should be treated accordingly.6,9,10 Given the chronic nature of CTCL, tolerability is an important consideration when choosing treatments.8

When patients progress and systemic treatment is next, consider starting with a therapy that is immunomodulatory.7

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THERAKOS® Photopheresis treatment regimen1

Additional dosing considerations1

  • Patients in the clinical study who were unresponsive to the normal treatment schedule were placed on the accelerated schedule and reassessed for response. The 3-month patient assessment can help inform whether to adjust the treatment schedule if indicated

  • Treatment schedule may vary based on individual response and the discretion of the healthcare provider 

  • There is no evidence to show that treatment with UVADEX beyond 6 months or using a different schedule provided additional benefit, and clinical experience does not extend beyond this treatment frequency

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Clinical staging of MF and SS4,8

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Treatment selection depends on the stage of disease or occurrence of disease progression4 

Early-stage MF (IA-IIA) is often managed with skin-directed treatments4 
  • Topicals 
  • Phototherapy 
  • Local radiation 
  • Total skin electron beam therapy 
  • Local radiation 
  • Total skin electron beam therapy 
Advanced-stage disease (IIB-IVB) is often managed with systemic treatments4 
  • Systemic retinoids 
  • Photopheresis (excluding tumor stage) 
  • Histone deacetylase inhibitors 
  • Targeted immunotherapy 
  • Chemotherapy 
  • Other 
Treatment selection may depend on several factors4,7,9 
Disease related 
  • Clinical stage (TNMB) 
  • Morphologic features 
  • Localization of malignant cells 
Patient related 
  • Age
  • Comorbidities 
  • Concomitant medications 
  • Insurance barriers 
Other considerations 
  • Recycling treatments 
  • Maintenance therapy 
  • NCCN Guidelines 
When choosing your patient’s next treatment, consider its side-effect profile and clinical efficacy.7

Prepare Your Patients by Setting Expectations

Help them know before they go

Patient adherence to medical recommendations may be impacted through the use of a patient-centered communication style to help build rapport and establish goals. Presenting patients with factual and clear recommendations can help patients follow their treatment plan.16

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Photopheresis is not an immediate-response treatment

Clinical response to immunotherapy may take longer to assess than with conventional agents because immunotherapy works by triggering an immune response.17 Set expectations that results may come, but it could take at least 3 to 6 months.18

An assessment is appropriate during the fourth treatment cycle, which is approximately 3 months after initiation. The approved course of treatment is a minimum of 7 cycles.1

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These minor lifestyle adjustments may help patients get ready

  • Hydrating prior to the procedure in anticipation of fluid shifts.19,20 Drinking enough water and juice while reducing alcohol and caffeine intake starting 2 days prior to a procedure is preferred21,22

  • Avoiding high-fat foods the night before and on the day of the procedure.15 Low-fat, healthy meals are preferred

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Patient information and resources

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Connecting Patients to Treatment Centers*

Find a local treatment center or contact our Customer Care team at 1-833-223-4ECP (1-833-223-4327).

*Treatment centers are independent, third-party facilities not owned or operated by Therakos LLC.

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Patient Stories Cta

Patient stories

It may help your patients to hear from people who were treated with THERAKOS® Photopheresis. There are a number of personal stories available that cover a range of experiences that your patients may find relatable.

View patient stories

References:
1. UVADEX (methoxsalen) Sterile Solution (prescribing information). Therakos LLC 2. Knobler R, Arenberger P, Arun A, et al. European dermatology forum—updated guidelines on the use of extracorporeal photopheresis 2020—part 1. J Eur Acad Dermatol Venereol. 2020;34(12):2693-2716. doi:10.1111/jdv.16890 3. Bradford PT, Devesa SS, Anderson WF, Toro JR. Cutaneous lymphoma incidence patterns in the United States: a population-based study of 3884 cases. Blood. 2009;113(21):5064-5073. doi:10.1182/blood-2008-10-184168 4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Primary Cutaneous Lymphomas V.3.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed August 26, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org. 5. Pulitzer M. Cutaneous T-cell lymphoma. Clin Lab Med. 2017;37(3):527-546. doi:10.1016/j.cll.2017.06.006 6. Yumeen S, Girardi M. Insights into the molecular and cellular underpinnings of cutaneous T cell lymphoma. Yale J Biol Med. 2020;93(1):111-121. 7. Dummer R, Vermeer MH, Scarisbrick JJ, et al. Cutaneous T cell lymphoma. Nat Rev Dis Primers. 2021;7(1):61. doi:10.1038/s41572-021-00296-9 8. Olsen EA, Whittaker S, Willemze R, et al. Primary cutaneous lymphoma: recommendations for clinical trial design and staging update from the ISCL, USCLC, and EORTC. Blood. 2022;140(5):419-437. doi:10.1182/blood.2021012057 9. Olsen EA. Evaluation, diagnosis, and staging of cutaneous lymphoma. Dermatol Clin. 2015;33(4):643-654. doi:10.1016/j.det.2015.06.001 10. Trautinger F, Eder J, Assaf C, et al. European Organisation for Research and Treatment of Cancer consensus recommendations for the treatment of mycosis fungoides/Sézary syndrome. Eur J Cancer. 2017;77:57-74 11. Willemze R, Jaffe ES, Burg G, et al. WHO-EORTC classification for cutaneous lymphomas. Blood. 2005;105(10):3768-3785. 12. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology. Primary Cutaneous Lymphoma. V1.2023. Accessed January 5, 2023. nccn.org 13. Diamandidou E, Cohen PR, Kurzrock R. Mycosis fungoides and Sezary syndrome. Blood. 1996;88(7):2385-2409. 14. Hwang ST, Janik JE, Jaffe ES, et al. Mycosis fungoides and Sézary syndrome. Lancet. 2008;371(9616):945-957. 15. Prip A, Moller KA, Nielsen DL, et al. The patient-healthcare professional relationship and communication in the oncology outpatient setting: a systematic review. Cancer Nurs. 2018;41:E11-E22. 16. Lucas AS, Ciccolini K. Nursing best practice referral algorithm for the early detection of mycosis fungoides. J Derm Nurs Assoc. 2016;8(2):109-120. 17. Sharma P, Wagner K, Wolchok JD, Allison JP. Novel cancer immunotherapy agents with survival benefit: recent successes and next steps. Nat Rev Cancer. 2011;11(11):805-812. 18. Bisaccia E, Gonzalez J, Palangio M, et al. Extracorporeal photochemotherapy alone or with adjuvant therapy in the treatment of cutaneous T-cell lymphoma: a 9-year retrospective study at a single institution. J Am Acad Dermatol. 2000;43(2 Pt 1):263-271. 19. THERAKOS® CELLEX® Photopheresis System: Operator’s Manual for Use With Software 5.4. 1470493_Rev06_EN-US. Therakos LLC; 2020. 20. Hoen L, Pfeffer D, Schmidt JR, et al. Hydration status of geriatric patients is associated with changes in plasma proteome, especially in proteins involved in coagulation. Nutrients. 2023;15(17):3789. 21. Montoya GA, Bakuradze T, Eirich M, et al. Modulation of 3',5'-cyclic AMP homeostasis in human platelets by coffee and individual coffee constituents. Br J Nutr. 2014;112(9):1427-1437. 22. Sailer CO, Refardt J, Bissig S, et al. Effects of alcohol consumption on copeptin levels and sodium-water homeostasis. Am J Physiol Renal Physiol. 2020;318(3):F702-F709.

TKS-25-04816 updated 12/2025

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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

CAUTION: READ THE THERAKOS® CELLEX® PHOTOPHERESIS SYSTEM’S OPERATOR’S MANUAL PRIOR TO PRESCRIBING OR DISPENSING THIS MEDICATION.

UVADEX (methoxsalen) Sterile Solution should be used only by physicians who have special competence in the diagnosis and treatment of cutaneous T-cell lymphoma and who have special training and experience in the THERAKOS CELLEX Photopheresis System. Please consult the CELLEX Operator's Manual before using this product.

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, 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

ADVERSE REACTIONS

  • Side effects of photopheresis (UVADEX used with the THERAKOS Photopheresis Systems) were primarily related to hypotension secondary to changes in extracorporeal volume (>1%)

For the THERAKOS® CELLEX® Photopheresis Procedure:
INDICATIONS
The THERAKOS CELLEX Photopheresis System is indicated for use in the ultraviolet-A (UVA) irradiation, in the presence of the photoactive drug 8-methoxypsoralen (8-MOP), of extracorporeally circulating leukocyte-enriched blood, in the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL), in persons who have not been responsive to other forms of treatment.

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:

  • 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

ADVERSE REACTIONS

  • 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

Please see accompanying Full Prescribing Information, including the BOXED WARNING for UVADEX, and see the THERAKOS Photopheresis System Operator’s Manual.

 

IMPORTANT SAFETY INFORMATION
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CAUTION: READ THE THERAKOS® CELLEX® PHOTOPHERESIS SYSTEM’S OPERATOR’S MANUAL PRIOR TO PRESCRIBING OR DISPENSING THIS MEDICATION.

UVADEX (methoxsalen) Sterile Solution should be used only by physicians who have special competence in the diagnosis and treatment of cutaneous T-cell lymphoma and who have special training and experience in the THERAKOS CELLEX Photopheresis System. Please consult the CELLEX Operator's Manual before using this product.

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