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UVADEX® (methoxsalen) Sterile Solution is used with the THERAKOS CELLEX® Photopheresis System for the treatment of skin problems associated with cutaneous T-cell lymphoma (CTCL) in patients who have not responded to other types of treatment prescribed by their doctor.

Learn About CTCL Skin Symptoms

CTCL Hero

 

Cutaneous T-Cell Lymphoma (CTCL) is known for the red, scaly, itchy, skin symptoms and rash it may cause. CTCL skin symptoms can help doctors diagnose CTCL but they can also be confused with other diseases.

CTCL is a type of non-Hodgkin's lymphoma (a type of cancer). It is caused by cells that change in the blood and travel to the skin. CTCL is known as a systemic disease because these cells are found throughout the body.

Doctors diagnose CTCL based on signs, symptoms, and the results of blood and skin tests. They assign a stage to describe how advanced the disease is. CTCL staging also helps the healthcare team to find the right treatment to manage the skin symptoms of CTCL.

Nurse Patient Leaflet Edge

There are 2 main types of CTCL skin symptoms:

MYCOSIS FUNGOIDES (MF)

(my-KOH-sis fun-GOID-ees)

  • The most common type of CTCL
  • Tends to happen slowly over years

SÉZARY SYNDROME (SS)

(SEY-zhair-ee SIN-drohmm)

  • A less common type of CTCL
  • Happens faster
  • Cancer cells are found in the blood and the skin

What causes CTCL skin symptoms?

Treating the skin symptoms of CTCL

There are two main types of treatment for the skin symptoms of CTCL:

Skin-directed treatments

target skin lesions

  • Ultraviolet (UV) light
  • Steroids
  • Local radiation
  • Chemotherapy (put on the skin)
  • Retinoids (put on the skin)

Systemic treatments

work throughout the body

  • Photopheresis
  • Retinoids (taken by mouth)
  • Interferon
  • Chemotherapy (taken by mouth or through an IV)

Talk with your healthcare team about your CTCL skin symptoms and treatments that may help to control them.

Get answers to some common questions about CTCL skin symptoms

Remember that your healthcare team is always the best source of information about your diagnosis and treating your skin symptoms.
What is Cutaneous T-Cell Lymphoma (CTCL)?

CTCL is a rare type of lymphoma. This type of cancer is caused by cancerous T-cells. T-cells are a type of white blood cell that help find and fight infection throughout the body, including in the skin. When cancerous T-cells live in the skin, it is known as Cutaneous (skin) T-cell Lymphoma. 

What causes CTCL and CTCL skin symptoms?

Right now, there is no known cause of CTCL and its skin symptoms. It is not a genetic disease, so it is unlikely that you can pass it on to your children. CTCL is not contagious, so it cannot be spread to someone else.

CTCL Numbers Edge
Who is affected by CTCL and CTCL skin symptoms?

In the United States, it is thought that more than 25,000 people have CTCL. Each year, about 3,000 more people will learn they have CTCL. CTCL is hard to diagnose, so these numbers are only estimates. 

Cells Graphic Edge
How are the symptoms I see on my skin caused by cells in my blood?

CTCL is a cancer caused when lymphocytes, a type of white blood cell, change and travel through the blood but collect in the skin.

Once there, they cause the main symptoms of CTCL.

Is CTCL skin cancer?

CTCL is a type of blood cancer, not a type of skin cancer. CTCL involves T-cells—a type of white blood cell—that change and travel through the blood and affect the skin.

Most forms of CTCL are indolent. That means that they grow slowly over time. Some types, including Sézary syndrome, can be more aggressive.

Talk with your healthcare team to be sure you know what type of CTCL you have and what treatment options can best manage your CTCL skin symptoms.

What is the difference between mycosis fungoides (MF) and Sézary syndrome (SS)?

Mycosis fungoides (MF) and Sézary syndrome (SS) are the 2 most common forms of CTCL. MF tends to progress slowly while SS can be more aggressive, with cancerous cells being found in the blood throughout the body.

The signs and symptoms of CTCL can look different in MF and SS. People with MF usually have flat, red, scaly patches, or thick, raised lesions called plaques, or large bumps. People with SS often have very itchy, scaly skin that is red all over.

Talk with your healthcare team about your signs and symptoms. Ask which type of CTCL you have, and which treatment is right for your symptoms.

How serious is CTCL?

Most forms of CTCL are indolent. That means that they grow slowly over time. Some types, including Sézary syndrome, can be more aggressive.

Talk with your healthcare team to be sure you know what type of CTCL you have and what treatment options can best manage your CTCL skin symptoms.

Mycosis Fungoides Plaques 3
What are the most common CTCL skin symptoms?

Doctors have many ways of describing the skin symptoms of CTCL. For example, patches are the flat, rash-looking changes that may also make the skin scaly. Plaques are areas of skin that look like a thick, raised lesion. Bumps or nodules may also happen. Some people have one or all of these signs and symptoms. Many people also report itchy skin.

Talk with your healthcare team about your CTCL skin symptoms and what you can do to help control them.

How do the skin symptoms change in each stage of CTCL?

There are different stages of CTCL. The higher the stage, the more: 

  • Skin that is covered in lesions
  • Severe the lesions appear 

Ask your healthcare team about your CTCL skin symptoms. You may also want to download the Decision Aid to talk about what is important to you in a treatment.

Are CTCL skin symptoms contagious?

CTCL is a form of cancer caused when a certain type of blood cell changes and grows out of control. The skin symptoms are not a sign of an infection. They are not contagious and cannot be spread to another person.

Is there a cure for CTCL skin symptoms?

In rare cases, very advanced disease may be treated with a potentially curative procedure. However, it is associated with significant risks. Some treatments are able to help manage the skin symptoms of CTCL. Talk with your doctor about your CTCL skin symptoms and what you can do to help manage them.

Inside Outside 3
What are the types of treatments for CTCL skin symptoms?

There are 2 main types of treatments for skin symptoms.

  • Skin-directed treatments target skin
  • Systemic treatments work from inside the body

Talk with your healthcare team about your CTCL skin symptoms and what treatment may be right for you.

Download our handout to learn more about CTCL skin symptoms.

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What Is Ctcl Cover Download

Watch the video and listen to Lou’s experience with THERAKOS Photopheresis

Diagnosed with CTCL 25 years after skin symptoms first appeared, Lou was hopeful about photopheresis after trying a few other treatments but still struggling with CTCL skin symptoms.

Patient Stories

Featured patients have been compensated for sharing their stories. Results may vary.

The health status of the patient in the video reflects his or her condition at the time the video was recorded and may have changed over time.

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IMPORTANT SAFETY INFORMATION
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UVADEX (methoxsalen) Sterile Solution should only be used by doctors who have special skills in the diagnosis and treatment of CTCL and who have received special training and have experience in the THERAKOS CELLEX Photopheresis System.

DO NOT USE UVADEX IF:

  • You are allergic to methoxsalen, any product similar or related to it, such as psoralen, or any of the other ingredients in UVADEX.
  • You have a history of a light-sensitive condition or disease.
  • You have had an eye lens removed; use of UVADEX in this condition can increase the risk of retinal damage.

WARNINGS

  • You may be at greater risk of sun sensitivity with UVADEX. Tell your doctor if you are taking other medications that cause sensitivity to sunlight, 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.
  • If you are pregnant or plan to become pregnant, tell your doctor. Methoxsalen can harm your unborn baby. Tell your doctor right away if you become pregnant during your UVADEX treatment. If you are breastfeeding or plan to breastfeed, tell your doctor. It is not known if methoxsalen passes into your breastmilk.
  • After UVADEX is given, exposure to sunlight and/or ultraviolet radiation may result in premature aging of your skin.
  • Let your doctor know if you currently have skin cancer or if you had skin cancer in the past.
  • If you are given too much UVADEX, you may get serious burns from UVA or sunlight (even through window glass).
  • Avoid exposure to sunlight during the 24 hours after treatment.
  • Exposure to UVA light when UVADEX is used can cause cataract formation if proper eye protection is not used.
  • You must wear UVA light-absorbing, wrap-around sunglasses for the 24 hours after treatment with UVADEX when you are exposed to direct or indirect sunlight, whether you are outdoors or exposed through a window.
  • If you are being treated for Graft vs Host Disease (GVHD), consult your physician for information regarding blood clots involving the lung and other parts of the body which have been reported in these patients. The use of UVADEX for the treatment of GVHD is not approved by the FDA.
  • Safety of UVADEX in children has not been shown.

SIDE EFFECTS OF UVADEX

  • Side effects of UVADEX used with the THERAKOS Photopheresis System are mainly related to low blood pressure.

For the THERAKOS CELLEX Photopheresis System procedure:

What is the THERAKOS Photopheresis System procedure?

The THERAKOS CELLEX Photopheresis System procedure is a medical procedure in which blood from a patient is collected into a specialized machine that separates the white blood cells from the other blood components. The other blood components are returned to the patient and white blood cells are then treated with UVADEX, which makes them sensitive to ultraviolet light. The treated white blood cells are exposed to UVA irradiation inside the machine, and then returned to the patient. This medical procedure is used to treat skin problems associated with CTCL in patients who have not been responsive to other forms of treatment given by their doctor.


DO NOT UNDERGO THE THERAKOS PHOTOPHERESIS SYSTEM PROCEDURE IF:

  • You have a condition that makes you unable to tolerate loss of blood volume.
  • You are allergic or hypersensitive to 8-methoxypsoralen, methoxsalen, or psoralen compounds.
  • Your doctor has diagnosed you with a blood-clotting or bleeding problem that can lead to either a blood clot or excessive bleeding.
  • You have had your spleen removed.

WARNINGS FOR THE THERAKOS PHOTOPHERESIS SYSTEM PROCEDURE

  • Treatments with THERAKOS Photopheresis System should always be performed where standard medical emergency equipment is available.
  • THERAKOS Photopheresis System procedures should not be performed on the same day as procedures that can cause fluid changes, such as renal dialysis.

SIDE EFFECTS OF THE THERAKOS PHOTOPHERESIS SYSTEM PROCEDURE

  • Low blood pressure can occur with the THERAKOS Photopheresis System procedure.
  • You may get an infection and/or feel pain at the site of injection.
  • Fevers of 100–102°F (37.7–38.9°C) have been seen in some patients within 6 to 8 hours after treatment. Redness of the skin may also occur with the fever.
  • A decrease in red blood cells can occur if the THERAKOS Photopheresis System procedure is given too frequently. Low levels of red blood cells may cause you to feel tired.

These are not all of the possible side effects of the THERAKOS Photopheresis System procedure.


Tell your doctor about any side effects that bother you, or that do not go away. Call your doctor or pharmacist for medical advice about side effects. You may report side effects to the FDA.Call 1-800-FDA-1088 or visit www.fda.gov/medwatch. You may also report side effects by calling Mallinckrodt at 1-877-566-9466.


Please see the full Prescribing Information, including the BOXED WARNING, for UVADEX.

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