Clinical Efficacy for THERAKOS® Photopheresis

HELP TACKLE CTCL SKIN SYMPTOMS WITH A STRATEGIC TREATMENT APPROACH

Clinical trial efficacy was established in patients unresponsive to skin-directed CTCL treatments, including tough-to-treat disease1,2*

 

  • Three multicenter, single-arm, open-label trials studied efficacy and safety. Success was predefined as a skin score reduction of ≥25% from baseline maintained for 4 consecutive weeks1

  • Although the response rates with UVADEX in Trial 3 and oral methoxsalen in Trial 2 were similar, the possibility that UVADEX is inferior in efficacy to oral methoxsalen cannot be excluded due to the design and size of the clinical trials1

  • In Trial 3, 15 of 17 responses were observed within 6 months and 2 responses were observed after 6 months1

  • The higher response rate with oral methoxsalen in Trial 1 may be partly due to the coadministration of systemic steroids and patients receiving more ECP treatments (mean number of treatments: Trial 1=64; Trial 2=31; Trial 3=20)1

  • No patients with disease in the tumor phase were treated and there are no data available regarding efficacy of UVADEX in patients with disease in the tumor phase1

Tolerability Profile

Well-tolerated therapy that helps manage the skin manifestations of CTCL*

THERAKOS Photopheresis has an established tolerability profile.

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

  • In Trial 31:

    • Six serious cardiovascular AEs (5 unrelated to photopheresis) were reported in 5 patients (10%)

    • Six infections were also reported in 5 patients

    • Two were Hickman catheter infections in 1 patient

    • <0.01% incidence of rash, allergic reaction, pyrexia, nausea, and dysgeusia, as shown in a postmarketing data analysis

*UVADEX is indicated for extracorporeal administration with the THERAKOS UVAR XTS or THERAKOS CELLEX Photopheresis System in the palliative treatment of the skin manifestations of CTCL that are unresponsive to other forms of treatment.

Real-world Experience for Over 30 Years and More Than 1 Million Treatments Administered2

Hear from patients with CTCL skin symptoms treated with THERAKOS Photopheresis

Snapshot of Ann's video

Actual photopheresis patient who has been
compensated for sharing her story.

Patient profile: Ann

The most obvious initial improvement that I experienced was relief from persistent itchiness. This may not seem like an important improvement to people who have not experienced the itching and other skin issues caused by CTCL.

Actual photopheresis patient who has been
compensated for sharing his story.

Patient profile: Lou

When I went on vacation, I missed a treatment, and I didn’t go for 2 months. Big mistake. I started flaring up. My skin became red and hot, and that chapped-and-chafed look came back. That’s how I really knew that photopheresis was having an effect.

References:

  1. UVADEX (methoxsalen) [prescribing information]. West Chester, PA: Therakos, Inc.; February 2018.

  2. Data on file. Mallinckrodt Pharmaceuticals.

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 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.

ADVERSE REACTIONS

Side effects of photopheresis (UVADEX used with the THERAKOS Photopheresis System) 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.
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