THERAKOS™ Photopheresis has been approved by the US Food and Drug Administration (FDA) for the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL) that is unresponsive to other forms of treatment. THERAKOS™ Photopheresis is designed to provide a safe treatment:
Treatment is usually begun on 2 consecutive days, once a month, for about 6 months. In patients who fail to show a response after several treatments, the treatments may be administered closer together—that is, 2 consecutive days every 2 weeks. If you do have a positive response to therapy, the frequency of treatment may be decreased gradually or, in some cases, stopped entirely.
An overnight stay is typically not required. Most people receive photopheresis as an outpatient procedure. They are admitted to the hospital for several hours and receive the treatment in a lounge chair or hospital bed. While undergoing the procedure, patients are able to read or watch television. Once the treatment is completed, patients are able to go home. However, each patient is different, and in some cases your underlying condition may require an overnight stay in the hospital. Talk with your doctor about your options—he or she will recommend the best plan for you based on your particular health needs.
Typically, the procedure takes from one and a half to 3 hours, although treatment time varies from patient to patient.
Most patients report little to no discomfort. You may feel minor discomfort when the IV needle is inserted. If you are concerned about this possibility, you can ask your nurse or doctor about receiving a local anesthetic. You may experience sensations during the procedure that are not painful, such as a slight pulsing from the instrument's pump, a slight chill, or a cool feeling where blood reenters the body. In very rare cases, some patients have a bitter or sour taste in their mouth for a brief period (30 minutes or less).
A small number of patients feel a little weak or dizzy during or immediately after the procedure. This is typically associated with a slight drop in blood pressure that can usually be corrected by your healthcare provider. Eating a small, nonfat meal before your treatment may prevent this as well. If you experience any dizziness or weakness, tell your photopheresis provider.
The medication used in the photopheresis treatment will make you more sensitive to sunlight for about 24 hours after the treatment. For this reason, you must take some simple but very important precautions to protect your eyes and skin. (Without taking these precautions, you put yourself at risk for cataracts or serious sunburns.) For 24 hours, you should:
Other possible side effects are usually minor and go away within a day. These could include fatigue, temporary increase in itchiness, or a slight fever or redness appearing 6 to 8 hours after treatment. There is a small risk for developing an infection around the needle puncture site. Talk to your doctor about any concerns you may have about potential risks or side effects.
Risks associated with the procedure include a drop in blood pressure, fever, or worsening of skin redness, which usually resolves in 1 day.
Currently, we do not know what causes CTCL.3 Research does not suggest that it’s inherited, so you can’t pass the disease on to your children. Nor is CTCL an infectious disease, so you can’t spread it to anyone else.2 No environmental factors, such as chemicals or toxins, have been linked to CTCL.
There is currently no cure for CTCL. Therapies applied to the skin, as well as those taken orally or by injection, can reduce symptoms and put some patients with the disease into remission. Research has shown that patients who are diagnosed with CTCL-MF at an early stage of the disease can have a normal life expectancy.14
CTCL most commonly affects older people. The average age at the time of diagnosis is 55 years. Children are rarely affected. For unknown reasons, CTCL occurs roughly twice as often in men as in women. Each year, approximately 1500 people in the United States are diagnosed with CTCL.3 However, because of the difficulties that may arise in diagnosing CTCL, these statistics may not be accurate.
Most lymphomas begin in a lymphocyte in a lymph node. Damage to the cell's genetic material (DNA) causes the cell to change. This is called a mutation. The abnormal cell divides and grows in an uncontrolled way, resulting in a tumor.3
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Methoxsalen Sterile Solution is indicated for extracorporeal administration with the THERAKOS™ UVAR XTS® or THERAKOS™ CELLEX® Photopheresis System in the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL) that is unresponsive to other forms of treatment.
Methoxsalen is not appropriate for patients who have had a reaction to psoralen compounds, patients who have had a light sensitive disease, or patients with an absence of one or both lenses of the eye.
THERAKOS™ Photopheresis is not appropriate for patients who cannot tolerate blood volume changes or patients with blood clotting disorders. See Important Safety Information for additional details.