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.
It is normal to have questions when thinking about or starting a new treatment. Here are answers to common questions about THERAKOS Photopheresis. Remember that your healthcare professional is always the best source of information about your treatment.
About THERAKOS Photopheresis
Is THERAKOS Photopheresis FDA approved?
THERAKOS Photopheresis has been approved by the US Food and Drug Administration (FDA) to treat the skin symptoms of CTCL in people who have not responded to other types of treatment prescribed by their doctors. It has been used since 1987.
What happens to the blood during the photopheresis process?
THERAKOS Photopheresis is a sterile process during which the procedural kit is used only once and is thrown out after each treatment. All steps in the treatment process—collecting and separating the blood, treating the white blood cells with medicine and UVA light, and returning the treated cells to the body—happen within one closed system. Blood is not removed from the THERAKOS Photopheresis closed system. During the procedure, the white blood cells that have been separated from the rest of your blood are treated.
Be sure to talk with your healthcare professional about the potential side effects of THERAKOS Photopheresis and any other risks.
How often would I receive THERAKOS Photopheresis?
You and your doctor should work together to make a treatment plan that is right for you. For most people, treatment:
Results may vary from person to person. It is not possible to predict if and how well this therapy will work for you. Although you may see results sooner, your doctor may suggest that you give your treatment a minimum of 6 months. Your doctor will talk with you about how long your therapy should continue.
Do I have to spend the night in the hospital?
Most people with CTCL skin symptoms get photopheresis as an outpatient procedure. They receive the treatment in a lounge chair or hospital bed in an outpatient setting. While getting treatment, you may be able to read, watch TV, email, or nap to pass the time. Once the treatment is done, you are able to go home.
Each person is different. Your healthcare professional will watch how you respond to treatment and decide what is best for you. Be sure to tell your healthcare professional how you are feeling.
How long will it take to get each treatment administered?
The time it may take to get your treatment may be different and will depend on how your healthcare professional decides to deliver it. CELLEX—the latest generation photopheresis system—can deliver treatment in as little as 1.5 to 4 hours.
What does the procedure feel like? Is it painful?
You may feel pain at the injection site when the IV line is inserted into your arm. If you are worried about this, ask your healthcare professional about ways to potentially lessen this discomfort.
It is important to tell your healthcare professional how you feel during treatment. During treatment, some people may feel:
What are the side effects of THERAKOS Photopheresis?
Side effects seen in clinical trials of THERAKOS Photopheresis include:
These are not all of the possible side effects of THERAKOS Photopheresis. Tell your doctor about any side effects that bother you, or that does not go away. Call your doctor 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.
About Cutaneous T-Cell Lymphoma (CTCL) skin symptoms
What is CTCL?
Cutaneous T-Cell Lymphoma (CTCL) is a cancer that attacks the skin; it is rare. CTCL is one of many kinds of cancers called non-Hodgkin lymphoma.
Lymphomas are cancer that effect lymphocytes. Lymphocytes are a type of white blood cell that helps to find and fight an infection. Lymphocytes become cancerous when they change (mutate) and grow out of control.
What causes CTCL?
Right now, there is no known cause of CTCL. It is not a genetic disease and thus it is unlikely that you can pass it on to your children. CTCL is not contagious, so it cannot be spread to someone else. No known environmental factors, such as chemicals or toxins, have been linked to CTCL at this time.
Is there a cure for CTCL?
There are no treatments that can cure CTCL. Some treatments, though, are able to help manage the skin symptoms. Talk with your doctor about your CTCL skin symptoms and what you can do to help manage the symptoms.
Who is affected by CTCL?
In the United States and Canada, it is estimated that more than 30,000 people have CTCL. Each year, about 3,000 additional people will learn they have CTCL. CTCL is more common in people over the age of 50. It is also more likely to affect men than women. CTCL is hard to diagnose, so these numbers are only an estimate.
IMPORTANT SAFETY INFORMATION
DO NOT USE UVADEX IF:
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
DO NOT USE UVADEX IF:
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:
WARNINGS FOR THE THERAKOS PHOTOPHERESIS SYSTEMS PROCEDURE
SIDE EFFECTS OF THE THERAKOS PHOTOPHERESIS SYSTEMS PROCEDURE
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.