UVADEX 20 micrograms/ml SOLUTION FOR BLOOD COMPONENT MODIFICATION

Introduction

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.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you experience any side effects, talk to your doctor, even if they are not listed in this leaflet. See section 4.

Contents of the pack:

1. What UVADEX is and what it is used for
2. What you need to know before you use UVADEX
3. How to use UVADEX
4. Possible side effects
5. Storage of UVADEX
6. Contents of the pack and further information

1. What UVADEX is and what it is used for

The name of this medicine is UVADEX 20 micrograms/ml solution for modification of blood fractions.

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.

2. What you need to know before you use UVADEX

Do not use UVADEX:

A

Talk to your doctor before you start using UVADEX

• If you suffer from EPILEPSY and are being treated with phenytoin (this may make UVADEX treatment ineffective).
• If you have SKIN CANCER (melanoma, basal cell carcinoma, or squamous cell carcinoma).
• If you have LIVER or KIDNEY problems.
• If you are taking tolbutamide for DIABETES (may increase photosensitivity).
• If you have recently been in the sun before treatment.
• If you are taking any other medicine that causes sensitivity to light, including some antibiotics (e.g., ciprofloxacin, doxycycline, and nalidixic acid), some diuretics, some medicines used to treat diabetes (e.g., chlorpropamide), some medicines used to treat mental health problems (e.g., trifluoperazine and haloperidol), and some medicines used to treat skin conditions (e.g., isotretinoin).
• If there is any possibility that you may become PREGNANT (see previous section).

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".

3. How to use UVADEX

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.

4. Possible side effects

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):

• Low blood pressure.
• Nausea (feeling sick) and vomiting.
• Infections.
• Transient fever (may appear 6-8 hours after treatment).
• Venositis (as a result of repeated insertion of the needle into the veins).
• Altered taste.

Uncommon:

• Photosensitivity.

Frequency not known (frequency cannot be estimated from the available data):

• Allergic reaction.

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.

5. Storage of UVADEX

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.

6. Contents of the pack and further information

Composition of UVADEX

• The active ingredient is methoxsalen.
• Each 10 ml vial contains 200 micrograms (µg) of methoxsalen. Each milliliter contains 20 micrograms of methoxsalen.
• The other ingredients are ethanol 95%, propylene glycol, glacial acetic acid, sodium acetate trihydrate, sodium chloride, sodium hydroxide, and water for injection.

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/