Cutaneous T-Cell Lymphoma (CTCL) is known for the red, scaly, itchy, flaky skin symptoms and rash it may cause. These 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 where they will live. Because these cells are found throughout the body, CTCL is known as a systemic disease. There are 2 main types of CTCL:
MYCOSIS FUNGOIDES (MF)
(my-KOH-sis fun-GOID-ees)
SÉZARY SYNDROME (SS)
(say-ZHAIR-ee sin-drohmm)
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.
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IMPORTANT SAFETY INFORMATION
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DO NOT USE UVADEX IF:
The information below is about the use of UVADEX® (methoxsalen) Sterile Solution with the THERAKOS CELLEX® Photopheresis System for the treatment of skin conditions associated with Cutaneous T-Cell Lymphoma (CTCL) unresponsive to other types of treatment.
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 CELLEX Photopheresis System 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
DO NOT USE UVADEX IF:
WARNINGS
SIDE EFFECTS OF UVADEX
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:
WARNINGS FOR THE THERAKOS PHOTOPHERESIS SYSTEM PROCEDURE
SIDE EFFECTS OF THE THERAKOS PHOTOPHERESIS SYSTEM PROCEDURE
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.