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UVADEX® (methoxsalen) Sterile Solution is used with the THERAKOS UVAR XTS® or THERAKOS CELLEX® Photopheresis Systems for the treatment of skin problems associated with Cutaneous T-Cell Lymphoma (CTCL) in patients who have not responded to other types of treatment given by their doctor.

Is THERAKOS® Photopheresis right for you?

CTCL often causes changes to your skin that you and others can see. THERAKOS Photopheresis is a treatment that works from within your body on the CTCL skin symptoms you see on the outside. Learn all you can about this treatment and talk with your doctor about if it may be right for you.

Why does THERAKOS Photopheresis use blood from inside your body?

  • THERAKOS Photopheresis may help your body manage the cells involved in the skin symptoms of CTCL
  • Getting closer to the source of the problem, which involves your blood and your immune system, may help relieve your skin symptoms. This is the goal of THERAKOS Photopheresis
  • With a little help, your body’s immune system can be put to work to help you. THERAKOS Photopheresis may empower your immune system to work on your CTCL skin symptoms from the inside out

NOTE: The exact way that THERAKOS Photopheresis works is not known.

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Learn more about what happens during treatment with THERAKOS Photopheresis.

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Some points to know about THERAKOS Photopheresis

It is important to talk with your doctor about the potential benefits and risks of treatment when choosing a treatment option. When talking with your doctor about THERAKOS Photopheresis, know that:

  • You should avoid pregnancy, as the medicine used may harm an unborn child
  • You should avoid sunlight for 24 hours after treatment. Talk with your doctor about your sun sensitivity risks
  • Results may vary from person to person. It is not possible to predict if and how well this therapy will work for you
  • Seeing results may take time. Although you may see results sooner, you should give your treatment a minimum of 6 months. Your doctor should talk with you about how long your therapy should continue
  • There are some risks and side effects that may happen with treatment. Be sure to talk with your doctor about them

Work with your doctor to make the best plan for you

Only your doctor can prescribe THERAKOS Photopheresis. You can take an active role in your treatment decisions. Together, you can come up with a plan that works for you.

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Download the Decision Aid for help talking with your doctor to learn if THERAKOS Photopheresis is right for you.

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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 UVAR XTS or THERAKOS CELLEX Photopheresis Systems.

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.

The information below is about the use of UVADEX® (methoxsalen) Sterile Solution with the THERAKOS® UVAR XTS® or THERAKOS CELLEX® Photopheresis Systems for the treatment of skin conditions associated with Cutaneous T-Cell Lymphoma (CTCL).

 

It is recommended that you discuss the therapy and your conditions with your doctor.

 

What is UVADEX (methoxsalen [meth-ox-sah-len]) Sterile Solution?

UVADEX (methoxsalen) Sterile Solution is used with the THERAKOS UVAR XTS or THERAKOS CELLEX Photopheresis Systems for the treatment of skin problems associated with CTCL in patients who have not responded to other types of treatment given by their doctor.

IMPORTANT SAFETY INFORMATION

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 UVAR XTS or THERAKOS CELLEX Photopheresis Systems.

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 Systems are mainly related to low blood pressure.


For the THERAKOS UVAR XTS/CELLEX Photopheresis Systems procedure:

 

What is the THERAKOS Photopheresis Systems procedure?

The THERAKOS UVAR XTS/CELLEX Photopheresis Systems 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 SYSTEMS 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 SYSTEMS PROCEDURE

  • Treatments with THERAKOS Photopheresis Systems should always be performed where standard medical emergency equipment is available.
  • THERAKOS Photopheresis Systems 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 SYSTEMS PROCEDURE

  • Low blood pressure can occur with the THERAKOS Photopheresis Systems 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 Systems 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 Systems 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 1-800-778-7898.

 

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