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.
How THERAKOS Photopheresis works
THERAKOS Photopheresis treats from the inside out. Going inside the body with immunotherapy may get closer to the source of outside symptoms, like red, itchy, flaky skin.
While the exact way that THERAKOS Photopheresis works is not known, it is thought to help balance the cancer-fighting cells and the cancer cells. Over time, as more cancer-fighting cells take over, fewer cancer cells accumulate. This is how CTCL skin symptoms may improve.
A treatment that gets closer to the source of the problem, which involves your blood and your immune system, may help relieve your skin symptoms, such as redness, scaliness, and itchiness. This is the goal of THERAKOS Photopheresis. With a little help, your body’s immune system can be put to work to help manage your CTCL skin symptoms from the inside out.
NOTE: The exact way that THERAKOS Photopheresis works is not known.
During the procedure, a small amount of white blood cells is collected, separated from the rest of the blood, treated, and returned back into your body. In fact, only a small amount of the white blood cells in your body are needed.
During the THERAKOS Photopheresis process, disposable procedure kits are used only once and 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.
Be sure to talk with your healthcare professional about the potential side effects of THERAKOS Photopheresis and any other risks. Please see the full Prescribing Information for more information on side effects.
Receiving treatment
You and your doctor should work together to make a treatment plan that is right for you. For most people, treatment:
Happens for 2 DAYS in a row, EVERY 4 WEEKS
Lasts ABOUT 2 HOURS with the CELLEX instrument
Results may vary from person to person. It is not possible to know if and how well this therapy will work for you. Although you may see results sooner, your doctor may prescribe treatment for a minimum of 6 months. Your doctor will talk with you about how long your therapy should continue.
The time it takes to get your treatment may vary and will depend on how your healthcare professional decides to deliver it. CELLEX—the latest generation photopheresis system—can deliver treatment in about 2 hours.*
*Depending on the instrument and number of intravenous (IV) ports used.
Results may vary from person to person. It is not possible to know if and how well this therapy will work for you. Although you may see results sooner, your doctor may prescribe treatment for a minimum of 6 months. Your doctor will talk with you about how long your therapy should continue.
Most people with CTCL skin symptoms get photopheresis as an outpatient procedure. They receive the treatment sitting in a lounge chair or lying back in a hospital bed at an infusion center. 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 team will watch how you respond to treatment and decide what is best for you. Be sure to tell your healthcare team how you are feeling.
You do not need to bring someone with you for your treatment visits. Each person is different, though. You may wish to bring a friend or family member to help pass the time or to keep you company.
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 that may potentially lessen this discomfort.
It is important to tell your healthcare team how you feel during treatment. During treatment, some people may feel:
A slight pulsing from the instrument
A slight chill or cold feeling where the blood re-enters the body
THERAKOS Photopheresis treatment is given at an infusion center. These centers are most often found at larger hospitals that are a part of or work together with a local university. Ask your healthcare team about the nearest treatment center to you. Treatment centers are independent, third-party facilities not owned or operated by Mallinckrodt.
Find a treatment center near you or download a treatment directory.
Safety information for THERAKOS Photopheresis
THERAKOS Photopheresis is the only extracorporeal photopheresis (ECP) treatment approved by the US Food and Drug Administration (FDA). It is used 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.
Your doctor will decide if THERAKOS Photopheresis is the right treatment for you. People who should not receive treatment include those who:
Side effects seen in clinical trials of THERAKOS Photopheresis include:
Low blood pressure
An infection and/or pain at the injection site
Fever of 100‐102°F (37.7‐38.9°C) within 6 to 8 hours after treatment. Redness of the skin may also occur with the fever
A decrease in red blood-cell levels, which may cause you to feel tired; this can occur if you get treatment too often
These are not all of the possible side effects of THERAKOS Photopheresis. Please see the full Prescribing Information for more details. Tell your doctor about any side effects that bother you or that do 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 1-877-566-9466.
THERAKOS Photopheresis treatment may make you more sensitive to the sun. That is why you should avoid sunlight for the 24 hours after treatment. This includes direct and indirect sunlight, either outdoors or even through a window.
This is not all the information you will need to know about sun sensitivity during THERAKOS Photopheresis treatment. Please see the full Prescribing Information for more details. Be sure to talk with your doctor about them and to learn what you need to do during treatment.
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.