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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.

THERAKOS® CELLEX® Photopheresis System

Cellex Hero Image

Get to know the ECP procedure with the CELLEX® System

Steps in the procedure1:

  1. The instrument collects a fraction of blood from the patient
  2. The blood is separated by centrifugation
  3. Red blood cells and plasma are returned to the patient
  4. UVADEX® (methoxsalen), a photosensitizing agent,* is added to the buffy coat fraction† and cells are photo activated by UVA light
  5. The photoactivated buffy coat fraction† is reinfused to the patient

Please refer to the appropriate operator’s manual for further details prior to prescribing ECP therapy.


ECP, extracorporeal photopheresis; UVA, ultraviolet A.
*Exact mechanism of action (MoA) of UVADEX is unknown.
†The buffy coat fraction of a whole blood sample following centrifugation contains most of the white blood cells and platelets.
1. UVADEX (methoxsalen) Sterile Solution (prescribing Information). Therakos, Inc.

The THERAKOS® CELLEX® Photopheresis System is the world’s only FDA-approved ECP system.1,2

CELLEX® System average treatment time3

  • Single-needle mode: 105 mins per treatment
  • Double-needle mode: 75 mins per treatment

Key features

  • Flexibility of switching between single- or double-needle modes during the procedure1,4
  • Enables adapting to the patients’ venous access conditions1
  • Because your patient remains connected throughout the procedure:
    • Re-infusion errors and risk of cross-contamination is minimized2,4,5
    • Risk of microbial contamination is minimized2,5

 

1. THERAKOS® CELLEX® Photopheresis System Operator's Manual. 147493_Rev06_EN-US. Mallinckrodt; 2020. 2. Perotti C, Sniecinski I. Transfus Apher Sci. 2015;52(3):360-368. 3. Data on file. Ref-01420. Mallinckrodt Pharmaceuticals. 4. Bisaccia E, et al. Br J Dermatol. 2009;161(1):167-169. 5. Knobler R, et al. J Eur Acad Dermatol Venereol. 2020;34(12):2693-2716.

CELLEX® System provides the versatility to treat a range of patients based on the following parameters1:

Vascular access
Choice of single- or double-needle mode and ability to switch between the two according to venous access conditions

Abnormal lipid and bilirubin in plasma
Bowl optic sensor allows customization of the system to the needs of abnormal plasma conditions

Adjustable to cardiac, pulmonary or renal function

Fluid shifts minimized in double-needle mode

 

1. THERAKOS® CELLEX® Photopheresis System Operator's Manual. 147493_Rev06_EN-US. Mallinckrodt; 2020.

Automated photosensitizing agent dosing calculations help minimize dosage errors caused by human computational mistakes1

Specific algorithm for consistent UVA irradiation automatically calculates and sets photoactivation time according to lamp life, % hematocrit of the leukocyte-enriched blood fraction, and treatment volume1

 

UVA, ultraviolet A.

1. THERAKOS® CELLEX® Photopheresis System Operator's Manual. 147493_Rev06_EN-US. Mallinckrodt; 2020.

CELLEX® System automatically controls buffy coat collection1

Bowl optic sensor automatically identifies the red cell layer

Allows automated adaptation to the patient’s plasma conditions and delivery of a consistent buffy coat

Automated flow rate controls may reduce pressure alarms and associated treatment interruptions

Hematocrit sensor provides automated detection of hematocrit

Automatically determines when buffy coat collection should end and final data automatically informs photoactivation time

 

1. THERAKOS® CELLEX® Photopheresis System Operator's Manual. 147493_Rev06_EN-US. Mallinckrodt; 2020.

Key features of the CELLEX® System

  • The world’s only fully integrated and validated platform for ECP1
  • Single, uninterrupted sterile fluid path2
  • Automated flow rate controls2
  • Automated flow rates may reduce pressure alarms and associated treatment interruptions2

Fully integrated and validated technology

  • One technology interface (integrated touchscreen)
  • One kit (single/double needle) for all procedures
  • Ability to capture procedural data
  • Device mobility enables use in both inpatient and outpatient settings*

*Contact your Therakos representative if you intend to move the CELLEX® device within your unit.

ECP, extracorporeal photopheresis.

1. Knobler R, et al. J Eur Acad Dermatol Venereol. 2020;34(12):2693-2716. 2. THERAKOS® CELLEX® Photopheresis System Operator's Manual. 147493_Rev06_EN-US. Mallinckrodt; 2020.

The THERAKOS CELLEX® Photopheresis system is designed for efficiency in extracorporeal photopheresis (ECP) administration—specifically developed to deliver ECP immunomodulation.1

 

1. THERAKOS® CELLEX® Photopheresis System Operator's Manual. 147493_Rev06_EN-US. Mallinckrodt; 2020.

Cellex Machine

Learn more about the THERAKOS® CELLEX® system components

The THERAKOS® Photopheresis system includes:

Cellex Instrument Thumb 2

CELLEX Instrument

The CELLEX instrument performs the extraction, treatment, and reinfusion of white blood cells for an integrated, closed photopheresis procedure.1

Download the CELLEX brochure

UVADEX Thumb

UVADEX (methoxsalen) Sterile Solution

UVADEX is the photosensitizing agent used to treat the white blood cells in the CELLEX photoactivation chamber.1

Full Prescribing Information for UVADEX

Procedural Kit Thumb

Procedural Kit

The procedural kit includes all single-use supplies needed to perform one treatment, including the photoactivation module, centrifuge bowl, treatment bag, return bag, and pump tubing.1 Customers can access updates to the Operator’s Manual and technical bulletin(s) through the MyTHERAKOS portal.

VISIT MYTHERAKOS PORTAL

1. THERAKOS® CELLEX® Photopheresis System Operator's Manual. 147493_Rev06_EN-US. Mallinckrodt; 2020.

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THERAKOS Photopheresis

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Clinical Profile

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Prescribing ECP

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Supporting Access to Treatment

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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.

For the THERAKOS® CELLEX® Photopheresis Procedure:

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.

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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