Cutaneous T-Cell Lymphoma (CTCL)

Reimagine Immunotherapy1-3

Activate the system, target the disease3,4

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THERAKOS® Photopheresis delivered a meaningful response in clinical trials5

In 3 multicentre, single-arm, open-label trials, efficacy and safety were established in patients (N=147) unresponsive to skin-directed CTCL treatments, including tough-to-treat disease.5,6 

A successful treatment response was defined as a ≥25% reduction in overall skin score from baseline maintained for 4 consecutive weeks.5

Study designs

Only patients with patch plaque, extensive plaque, and erythrodermic disease were enrolled in these studies. No patients with disease in the tumour phase were treated.5

  • CTCL 1 permitted prednisone up to 10 mg/day in addition to topical steroids5

  • CTCL 2 was a 5-year post approval follow-up to evaluate long-term safety and had no concomitant medication restriction5

  • CTCL 3, the clinical trial using UVADEX5,6,a

    • Patients had difficult-to-treat diseaseb and were on an average of 4.3 prior therapies 

    • There are no data available regarding the efficacy of UVADEX in patients with disease in the tumour phase

    • Patients were only permitted to use topical steroids for the treatment of fissures on the soles of the feet and palms of the hands (all other steroids, topical or systemic, were prohibited)

  • In CTCL 3:

    • Of the 17 responses, 15 were observed within 6 months and 2 after 6 months5

    • Clinical experience does not extend beyond this treatment duration, and there is no evidence to show that treatment with UVADEX beyond 6 months, or using a different schedule, provided additional benefit5

Although the response rate with UVADEX in CTCL 3 was similar to oral methoxsalen in CTCL 2, the possibility that UVADEX is inferior in efficacy to oral methoxsalen cannot be excluded due to the design and size of the clinical trials. The higher response rate with oral methoxsalen in CTCL 1 may be partly due to patients receiving more treatments (mean of 64 in CTCL 1, 31 in CTCL 2, and 20 in CTCL 3) and to the administration of systemic steroids in CTCL 1.5



warning-icon.svgParticipants were not required to have blood involvement to qualify for the trials, nor were they screened for it if they met inclusion criteria based on another positive criterion.5,6

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Given the chronic nature of CTCL, safety and tolerability are important considerations when choosing treatments7,8

THERAKOS® Photopheresis has been on the global market for almost 40 years with an established safety profile5,7*

  • Adverse events (AEs) in clinical trials were primarily related to hypotension secondary to changes in ECV (>1%)

  • In the UVADEX® (methoxsalen) clinical trial CTCL 3 (N=51):

    • 6 serious cardiovascular AEs (5 unrelated to Photopheresis) were reported in 5 patients (10%)

    • 6 infections were also reported in 5 patients

      • 2 were Hickman catheter infections in 1 patient

      • 4 infections were not related to Photopheresis

  • Adverse reactions reported from postmarketing experience included nausea, dysgeusia, photosensitivity reaction, pyrexia, and hypersensitivity reactions, including anaphylaxis and rash

warning-icon.svgPracticing proper infection control is critical to mitigating the potential for infection.

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References: 1. Worel N, Leitner G. Transfus Med Hemother. 2012;39(4):254-262. 2. Stevens SR, et al. Arch Dermatol. 2002;138(10):1347-1350. 3. Tsai YC, et al. Br J Dermatol. 2023;189(5):603-611. 4. Bladon J, Taylor PC. J Photochem Photobiol B. 2003;69(2):129-138. 5. UVADEX® (methoxsalen) Sterile Solution [product monograph]. Therakos (Canada) Company. 6. Data on File – REF-25-00334. Therakos (Canada) Company. 7. Knobler R, et al. J Eur Acad Dermatol Venereol. 2020;34(12):2693-2716. 8. 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.


NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.


aUVADEX formulation of methoxsalen and the UVAR Photopheresis System. UVAR is no longer manufactured and was replaced by the THERAKOS® CELLEX® Photopheresis System

bDefined as exhibiting progressive disease during the prior year6

*The THERAKOS UVAR was launched in 1987. The THERAKOS UVAR XTS™ Photopheresis System was first licensed in Canada in 1999 for the palliative treatment of the skin manifestations of CTCL unresponsive to other forms of treatment.

Important Safety Information for THERAKOS® CELLEX® Photopheresis Procedure

INDICATION

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) and systemic sclerosis (SSc).

CONTRAINDICATIONS

Certain underlying medical conditions contraindicate THERAKOS CELLEX Photopheresis, including:

  • Patients who cannot tolerate extracorporeal volume loss during the leukocyte enrichment phase

  • Patients exhibiting idiosyncratic or hypersensitivity reactions to 8-methoxypsoralen/psoralen compounds

  • Patients with coagulation disorders or who have had previous splenectomy

WARNINGS & PRECAUTIONS

THERAKOS CELLEX 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.

  • MR-Unsafe: Do not expose the device to a magnetic resonance (MR) environment. The device may present a risk of projective injury, and thermal injury and burns may occur. The device may generate artifacts in the MR image, or may not function properly.

  • Thromboembolic Events: Thromboembolic events, including pulmonary embolism and deep vein thrombosis, have been reported in the treatment of Graft versus Host Disease (GvHD), an indication not approved in Canada. Special attention to adequate anticoagulation is advised when treating patients with GvHD.

  • Concomitant Therapy: When prescribing and administering THERAKOS CELLEX 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 REACTIONS

Hypotension may occur during any treatment involving extracorporeal circulation. Monitor the patient closely during the entire treatment.

Transient pyretic reactions, 37.7-38.9 °C (100-102 °F), have been observed in some patients within 6-8 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.

Important Safety Information for Methoxsalen Sterile Solution Used in Conjunction with THERAKOS® CELLEX® Photopheresis System

CONTRAINDICATIONS

Methoxsalen Sterile Solution is contraindicated in:

  • Patients exhibiting idiosyncratic reactions to psoralen compounds

  • Patients with aphakia

  • Patients possessing a specific history of a light-sensitive disease state

SERIOUS WARNINGS & PRECAUTIONS

  • Concomitant Therapy: Exercise care in treating patients who are receiving concomitant therapy (either topically or systemically) with known photosensitizing agents.

  • Carcinogenicity: Oral administration of methoxsalen followed by cutaneous UVA exposure (PUVA therapy) is carcinogenic. Patients exhibiting multiple basal cell carcinomas or having a history of basal cell carcinoma should be diligently observed and treated.

  • Teratogenicity: Methoxsalen may cause fetal harm when given to a pregnant woman. Women undergoing photopheresis should be advised to avoid becoming pregnant.

  • Cataractogenicity: Patients should be told emphatically to wear UVA absorbing, wrap-around sunglasses for twenty-four (24) hours after methoxsalen treatment, any time they are exposed to direct or indirect sunlight and whether they are outdoors or exposed through a window.

  • Safety in children has not been established.

FOR MORE INFORMATION

See product monograph for methoxsalen sterile solution (if used in conjunction with the THERAKOS CELLEX Photopheresis System) and the Operator’s Manual for the CELLEX system at health-products.canada.ca/dpd-bdpp or by calling 1-833-223-4ECP (1-833-223-4327).

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Important Safety Information for THERAKOS® CELLEX® Photopheresis Procedure
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INDICATION

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) and systemic sclerosis (SSc).