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 prescribed by their doctor.
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Learn what to expect during THERAKOS® Photopheresis
Whether you and your healthcare team are thinking about THERAKOS Photopheresis, or if you are ready to get started, it is helpful to know what role you play in your care. Download and review the Plan and Prepare handout to learn how you can prepare for treatment. Together with your healthcare team, you can help make a plan that is right for you.
Watch this video to learn more before starting THERAKOS Photopheresis
KNOW your treatment schedule
You and your doctor should work together to make a treatment plan that is right for you. For most people, treatment:
- Is scheduled 2 DAYS in a row
- Can take ABOUT 2 HOURS*
- Will be given about EVERY 2 to 4 WEEKS for a minimum of 6 months
*Depending on the instrument and number of intravenous (IV) ports used.
PREPARE for treatment
Before Treatment
Two weeks before
Put your treatment dates in a calendar
Set a reminder for your treatment dates
Two days before
Drink plenty of fluids, such as water or juice, to stay hydrated
Avoid caffeine and alcohol, which can reduce the fluid in your body
The night before
Eat a low-fat, healthy meal that may include fruit, vegetables, whole grains (like oatmeal), low-fat or fat-free dairy (like yogurt), and protein (like fish, lean meat and chicken, nuts, beans)
Avoid high-fat foods, such as cream, high-fat meat, fried food, cheese, and butter
Day of Treatment
Bring your starter kit
(blanket, wrap-around sunglasses, sunscreen sample, squeeze ball, Action Plan)
Eat a low-fat breakfast and lunch
Visit the restroom right before treatment starts
You can read, email, watch TV, or nap to help pass the time during treatment
Make sure that your wrap-around sunglasses protect against ultraviolet A (UVA) light.
You will need to wear them when you are in sunlight for the 24 hours after treatment.
Keep your healthcare team informed about how you are feeling throughout treatment.
During treatment you may feel:
A slight pulsing from the instrument
A slight chill or cold feeling where your blood re-enters your body
Be sure to talk to your healthcare team if at any time you feel:
Dizzy or weak, which may be signs of low blood pressure
Pain at the injection site; you may also get an infection
Tired, which may be caused by low levels of red blood cells
After Treatment
Your doctor may want you to get treatment for at least 6 MONTHS.
Results vary from person to person. You may see results sooner.
Download and print this handout showing the ways you can plan and prepare for treatment.
Download the Action Plan to learn other steps that may help you get a good start.
Hear tips for preparing for treatment with THERAKOS Photopheresis.
IMPORTANT SAFETY INFORMATION
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DO NOT USE UVADEX IF:
- You are allergic to methoxsalen, any product similar or related to it, such as psoralen, or any of the other ingredients in UVADEX.
- You have a history of a light-sensitive condition or disease.
- You have had an eye lens removed; use of UVADEX in this condition can increase the risk of retinal damage.
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:
- You are allergic to methoxsalen, any product similar or related to it, such as psoralen, or any of the other ingredients in UVADEX.
- You have a history of a light-sensitive condition or disease.
- You have had an eye lens removed; use of UVADEX in this condition can increase the risk of retinal damage.
WARNINGS
- You may be at greater risk of sun sensitivity with UVADEX. Tell your doctor if you are taking other medications that cause sensitivity to sunlight, such as anthralin, coal tar or coal tar derivatives, griseofulvin, phenothiazines, nalidixic acid, halogenated salicylanilides (bacteriostatic soaps), sulfonamides, tetracyclines, thiazides, and certain organic staining dyes, such as methylene blue, toluidine blue, rose bengal, and methyl orange.
- If you are pregnant or plan to become pregnant, tell your doctor. Methoxsalen can harm your unborn baby. Tell your doctor right away if you become pregnant during your UVADEX treatment. If you are breastfeeding or plan to breastfeed, tell your doctor. It is not known if methoxsalen passes into your breastmilk.
- After UVADEX is given, exposure to sunlight and/or ultraviolet radiation may result in premature aging of your skin.
- Let your doctor know if you currently have skin cancer or if you had skin cancer in the past.
- If you are given too much UVADEX, you may get serious burns from UVA or sunlight (even through window glass).
- Avoid exposure to sunlight during the 24 hours after treatment.
- Exposure to UVA light when UVADEX is used can cause cataract formation if proper eye protection is not used.
- You must wear UVA light-absorbing, wrap-around sunglasses for the 24 hours after treatment with UVADEX when you are exposed to direct or indirect sunlight, whether you are outdoors or exposed through a window.
- If you are being treated for Graft vs Host Disease (GVHD), consult your physician for information regarding blood clots involving the lung and other parts of the body which have been reported in these patients. The use of UVADEX for the treatment of GVHD is not approved by the FDA.
- Safety of UVADEX in children has not been shown.
SIDE EFFECTS OF UVADEX
- Side effects of UVADEX used with the THERAKOS Photopheresis System are mainly related to low blood pressure.
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:
- You have a condition that makes you unable to tolerate loss of blood volume.
- You are allergic or hypersensitive to 8-methoxypsoralen, methoxsalen, or psoralen compounds.
- Your doctor has diagnosed you with a blood-clotting or bleeding problem that can lead to either a blood clot or excessive bleeding.
- You have had your spleen removed.
WARNINGS FOR THE THERAKOS PHOTOPHERESIS SYSTEM PROCEDURE
- Treatments with THERAKOS Photopheresis System should always be performed where standard medical emergency equipment is available.
- THERAKOS Photopheresis System procedures should not be performed on the same day as procedures that can cause fluid changes, such as renal dialysis.
SIDE EFFECTS OF THE THERAKOS PHOTOPHERESIS SYSTEM PROCEDURE
- Low blood pressure can occur with the THERAKOS Photopheresis System procedure.
- You may get an infection and/or feel pain at the site of injection.
- Fevers of 100–102°F (37.7–38.9°C) have been seen in some patients within 6 to 8 hours after treatment. Redness of the skin may also occur with the fever.
- A decrease in red blood cells can occur if the THERAKOS Photopheresis System procedure is given too frequently. Low levels of red blood cells may cause you to feel tired.
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.