
Ask a doctor about a prescription for UVADEX 20 micrograms/ml SOLUTION FOR BLOOD COMPONENT MODIFICATION
Package Leaflet: Information for the User
UVADEX
20 MICROGRAMS/ML SOLUTION FOR MODIFICATION OF BLOOD FRACTIONS
(methoxsalen)
Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.Keep this leaflet, you may need to read it again.
Contents of the pack:
Methoxsalen is a product that alters the body's response to light that is activated when exposed to UV radiation.
Cutaneous T-cell lymphoma (CTCL) is a blood disorder that causes abnormal growths that affect the skin. UVADEX is used in combination with the THERAKOS CELLEX photopheresis system to relieve the skin symptoms of cutaneous T-cell lymphoma (CTCL) when other treatments have not been effective.
The THERAKOS CELLEX photopheresis system provides the necessary UV light to activate methoxsalen, which then destroys the diseased white blood cells.
Do not use UVADEX:
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Talk to your doctor before you start using UVADEX
Children
The use of UVADEX is not indicated in children, as there is not enough experience in this age group.
Other medicines and UVADEX
Make sure your doctor knows what other medicines you are taking, including any that you may have bought for yourself, such as paracetamol.
Using UVADEX with food and drink
No studies have been conducted to evaluate the effect of food and drink. As UVADEX is administered as part of a hospital procedure, your specialist doctor will decide whether you can eat or drink during the procedure.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before taking this medicine. You should not be given UVADEX if you are pregnant or breastfeeding.
If you are a sexually active woman of childbearing age, during treatment with UVADEX, you must use adequate contraceptive methods because the active ingredient - methoxsalen - may be harmful to a child conceived during treatment with UVADEX.
Driving and using machines
You should not drive or operate machinery immediately after treatment.
UVADEX contains small amounts of ethanol
This medicine contains 217 mg of ethanol (alcohol) per 5.6 ml dose, which corresponds to 3.1 mg/kg per 5.6 ml dose. The amount of a 5.6 ml dose of this medicine is equivalent to less than 6 ml of beer or 3 ml of wine.
The small amount of alcohol in this medicine will not have noticeable effects.
UVADEX contains small amounts of sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose unit; it is essentially "sodium-free".
This medicine is always administered by a specialist doctor who can explain exactly what is happening. Your doctor will decide how many treatment sessions you need. Most patients receive treatment on two consecutive days once a month for six months. After four months, this frequency may be increased to two consecutive days twice a month if your doctor thinks it is necessary.
Method of administration
This medicine is administered as follows:
A professional with specific training in the use of photopheresis will insert a needle into your arm to remove blood into a specially designed instrument (the THERAKOS CELLEX photopheresis system) and separate it into red blood cells, white blood cells, and plasma. The red blood cells and most of the plasma are returned to your circulation during the procedure. The white blood cells and the remaining plasma are mixed with a calculated dose of UVADEX, exposed to UV light in the instrument, and then returned to you.
Duration of treatment
The procedure lasts between three and four hours from the time the needle is inserted until all blood components are returned to you.
You should not receive more than 20 photopheresis sessions in 6 months.
During treatment and for 24 hours after, you must wear special wrap-around sunglasses that prevent UVA rays from passing through to avoid damaging your eyes and causing cataracts.
After treatment
After receiving treatment, you should avoid sunlight for at least 24 hours because it could damage your skin, causing burns or premature aging in the long term. If you need to go outside, you must cover your skin, use a high sun protection factor, and wear sunglasses (see above).
If you use more UVADEX than you should
This is very unlikely. However, if you are given too much, you may need to stay in a dark room for 24 hours or more as part of your treatment.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported:
Common (may affect up to 1 in 10 people):
Uncommon:
Frequency not known (frequency cannot be estimated from the available data):
Reporting of side effects
If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Health Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.
UVADEX will be stored in the hospital pharmacy. Do not store above 25°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.
Composition of UVADEX
Appearance and pack contents
Clear, colorless solution.
10 ml amber glass vial with rubber stopper.
Marketing authorization holder and manufacturer
The marketing authorization holder is:
Therakos Europe Ltd,
College Business & Technology Park, Cruiserath, Blanchardstown, Dublin 15,
Ireland.
Manufacturer:
Penn Pharmaceuticals Limited
Unit 23, Tafarnaubach Industrial Estate
Tredegar, Gwent
United Kingdom
or
Therakos EMEA Ltd,
College Business & Technology Park,
Cruiserath Road,
Blanchardstown,
Dublin 15,
Ireland.
Date of last revision of this leaflet:June 2025.
Detailed information on this medicine is available on the website of the Spanish Medicines and Health Products Agency (AEMPS) http://www.aemps.gob.es/
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Discuss dosage, side effects, interactions, contraindications, and prescription renewal for UVADEX 20 micrograms/ml SOLUTION FOR BLOOD COMPONENT MODIFICATION – subject to medical assessment and local rules.