Important Safety InformationUVADEX® methoxsalen Prescribing InformationHealthcare Professionals

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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.

CTCL Skin Symptom Communities

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Connect with a CTCL skin symptom community

Although CTCL skin symptoms are rare, there is a community of support for those who have it, and also for their family and friends. Connecting can provide another source of information and support. It may also give you a chance to help others and raise awareness in your community of CTCL skin symptoms.

You may wish to learn more about the organizations below or your doctor may be able to connect you with other organizations and resources.

Cutaneous Lymphoma Foundation

Cutaneous Lymphoma Foundation (CL Foundation)

The CL Foundation is an independent, nonprofit patient advocacy organization dedicated to supporting every person affected by cutaneous lymphoma by promoting awareness and education, advancing patient care, and fostering research for the best possible outcomes.

View website

Cutaneous Lymphoma Foundation

Leukemia & Lymphoma Society (LLS)

The LLS has a mission to cure leukemia, lymphoma, Hodgkin's disease, and myeloma, and improve the quality of life of patients and their families through research, ensuring access, and policy and advocacy support.

Visit website

Lymphoma Research Foundation

Lymphoma Research Foundation (LRF)

The LRF is the nation’s largest lymphoma-focused health organization devoted to improving care through education and support services and improving outcomes through investment in the most promising lymphoma research. Its mission is to eradicate lymphoma and serve all those impacted by this blood cancer.

Visit website

This website identifies third-party organizations that are independent from Mallinckrodt and provides links to third-party websites and other third-party information (“Third-Party Content”). The Third-Party Content is meant for informational purposes only, is not endorsed by or under the control of Mallinckrodt, and is not meant to replace a physician’s medical advice. Mallinckrodt has no responsibility or liability for and makes no representations or warranties whatsoever about any Third-Party Content.  All trademarks, service marks and logos appearing on  these websites are the property of their respective owners. Any rights not expressly granted herein are reserved.

Mallinckrodt is always interested in learning of any other advocacy organizations.

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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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