Your patients may have questions related to the THERAKOS™ Photopheresis procedure. To assist you with explaining the procedure to your patients, a list of commonly asked questions and corresponding answers is provided.
THERAKOS™ Photopheresis has been approved by the US Food and Drug Administration (FDA). Therakos, Inc. has taken numerous steps to ensure the safety of this treatment. These steps include:
THERAKOS™ Photopheresis is indicated for the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma that are unresponsive to other forms of treatment.
Treatment is usually started on two consecutive days, once a month, for about 6 months. In patients who fail to show a response after several treatments, the treatments may be spaced closer together to 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, they are able to read or watch television. Once the treatment concludes, they 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 between 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 getting 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 re-enters the body. In very rare cases, some patients get a bitter or sour taste 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 drop in blood pressure that can usually be corrected by your healthcare provider. Eating a small, non-fat meal before your treatment may prevent this as well. If you feel any dizziness or weakness, tell your healthcare provider.
The medicine used in the THERAKOS™ 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 these precautions, you put yourself at risk for cataracts or serious sunburns). For 24 hours you should:
Other possible side effects usually are 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 of getting an infection around the needle puncture site. Talk to your doctor about any concerns you have about potential risks.
Risks associated with the procedure include a drop in blood pressure, fever, or worsening of skin redness, which usually resolves in 1 day.
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Indications
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 should be used only by physicians who have special training in the THERAKOS™ UVAR XTS® or THERAKOS™ CELLEX® Photopheresis Systems. Methoxsalen is contraindicated in patients exhibiting idiosyncratic reactions to psoralen compounds, patients with a specific history of a light sensitive disease, or patients with aphakia.
THERAKOS™ Photopheresis is not appropriate for patients who cannot tolerate extracorporeal volume loss or shifts, or patients with coagulation disorders. See Important Safety Information for additional details.
