Uvadex 20 micrograms/ml solution for modification of blood components

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

UVADEX

20 MICROGRAMS/ML SOLUTION FOR MODIFICATION OF BLOOD FRACTIONS

(methoxsalen)

Read this entire leaflet carefully before you start using the medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience any adverse reactions, consult your doctor, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of this leaflet:

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

1. What UVADEX is and what it is used for

The name of this medicine is UVADEX 20 microgram/ml solution for modification of blood components.

Methoxsalen is a substance that alters the body's response to light and becomes activated when exposed to UV radiation.

Cutaneous T-cell lymphoma (CTCL) is a blood disorder causing abnormal growths affecting the skin. UVADEX is used in combination with the THERAKOS CELLEX photopheresis system to relieve cutaneous symptoms of cutaneous T-cell lymphoma (CTCL) when other treatments have not been effective.

The THERAKOS CELLEX photopheresis system provides the UV light required to activate methoxsalen, which then destroys the diseased leukocytes.

2. What you need to know before using UVADEX

Do not use UVADEX:

Warnings and precautions

Consult your doctor before starting treatment with UVADEX

• If you have EPILEPSY and are being treated with phenytoin (this may make treatment with UVADEX 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 (this may increase photosensitivity).
• If you have recently been exposed to sunlight prior to treatment.
• If you are taking any other medicine that causes light sensitivity, including certain antibiotics (e.g.: ciprofloxacin, doxycycline and nalidixic acid), certain diuretics, certain medicines used to treat diabetes (e.g.: chlorpropamide), certain medicines used to treat mental health conditions (e.g.: trifluoperazine and haloperidol), and certain medicines used to treat skin conditions (e.g.: isotretinoin).
• If there is any possibility you could be PREGNANT (see the section above).

Children

UVADEX is not indicated for use in children, as there is insufficient experience in this age group.

Other medicines and UVADEX

Make sure that your treating doctor knows which other medicines you are taking, including any, such as paracetamol, that you may have purchased for yourself.

Use of 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 may eat or drink during a 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. UVADEX must not be given if you are pregnant or breastfeeding.

If you are a sexually active woman of childbearing age, you must use adequate contraceptive methods during treatment with UVADEX, because the active substance—methoxsalen—could be harmful to a child conceived during treatment with UVADEX.

Driving and use of 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) in each 5.6 ml dose, equivalent to 3.1 mg/kg per 5.6 ml dose. The amount in 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 contained 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; hence, it is essentially "sodium-free".

3. How to use UVADEX

This medicine is always administered by a specialist doctor who can clearly explain exactly what is happening. The 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 the doctor considers it necessary.

Method of administration

This medicine is administered as follows:

A healthcare professional trained specifically in photopheresis will insert a needle into your arm to draw blood into a specially designed device (the THERAKOS CELLEX photopheresis system), where it is separated into red blood cells, white blood cells, and plasma. The red blood cells and most of the plasma are simply reinfused back into your bloodstream during the procedure. The white blood cells and the remaining plasma are mixed with a calculated dose of UVADEX, exposed to ultraviolet (UV) light within the device, and then reinfused back into you.

Duration of treatment

The procedure lasts between three and four hours, starting from the moment the needle is inserted until all blood components have been reinfused.

You must not receive more than 20 photopheresis sessions within 6 months.

During treatment administration and for 24 hours afterwards, you must wear special wraparound-designed sunglasses at all times to block UVA rays, in order to prevent eye damage and cataract formation.

After treatment

After receiving treatment, you must avoid sunlight for at least 24 hours, as it could damage your skin, causing burns or long-term premature aging. If you need to go outdoors, you must cover your skin, use a high-protection sunscreen, and wear sunglasses (see above).

If you are given more UVADEX than you should

This is very unlikely. However, if you are given too much, you may need to remain in a darkened room for 24 hours or longer as part of your treatment.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The following adverse effects have been reported:

Frequent (may affect up to 1 in 10 people):

• Low blood pressure.
• Nausea (feeling sick) and vomiting (urge to vomit).
• Infections.
• Transient fever (may occur 6–8 hours after treatment).
• Damage to veins (as a result of repeated needle insertion into veins).
• Altered taste.

Uncommon:

• Photosensitivity.

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

• Allergic reaction.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse 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 stated on the carton after EXP. The expiry date is the last day of the month indicated.

6. Contents of the pack and other information

Composition of UVADEX

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

Appearance of the product and contents of the pack

Clear, colourless solution.

Amber glass vial of 10 ml with a rubber stopper.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation Holder is:

Therakos Europe Ltd,

College Business & Technology Park, Cruiserath, Blanchardstown, Dublin 15,

Ireland.

Manufacturer:

Penn Pharmaceuticals Limited

Unit 23, Tafarnabuch Industrial Estate

Tredegar, Gwent

United Kingdom

or

Therakos EMEA Ltd,

College Business & Technology Park,

Cruiserath Road,

Blanchardstown,

Dublin 15,

Ireland.

Date of the most recent review of this leaflet: June 2025.

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/