Package Insert: Information for the User

UVADEX

20 MICROGRAMS/ML SOLUTION FOR MODIFICATION OF BLOOD FRACTIONS

(metoxsaleno)

Read the entire package insert carefully before starting to use the medication,because it contains important information for you.

- Keep this package insert, as you may need to read it again.

- If you have any questions, consult your doctor or pharmacist.

- If you experience adverse effects, consult your doctor, even if they are not listed in this package insert. See section4.

1. What is UVADEX and what it is used for

2.What you need to know before starting to use UVADEX

3. How to use UVADEX

4. Possible adverse effects

5 Conservation of UVADEX

6.Contents of the package and additional information

El nombre de este medicamento esUVADEX 20microgramos/ml solution for modification of blood fractions.

The 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 hematopathy that causes abnormal growths affecting the skin. UVADEX is used in combination with the THERAKOS CELLEX photopheresis system to alleviate cutaneous 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 the methoxsalen that then destroys the diseased leukocytes.

Do not use UVADEX:

Warnings and Precautions

Consult your doctor before starting to use UVADEX.

• If you have EPILEPSY and are being treated with phenytoin (this may make UVADEX treatment ineffective).
• If you have liver or kidney problems.
• If you are taking tolbutamide for DIABETES (this may increase photosensitivity).
• If you have taken the sun recently before treatment.
• If you are taking any other medication that causes light sensitivity, including some antibiotics (e.g., ciprofloxacin, doxycycline, and nalidixic acid), some diuretics, some medications used to treat diabetes (e.g., chlorpropamide), some medications used to treat mental health problems (e.g., trifluoperazine and haloperidol), and some medications used to treat skin conditions (e.g., isotretinoin).
• If there is any possibility of becoming PREGNANT (see the previous section).

Children

The use of UVADEX is not indicated in children, as there is not enough experience in this age group.

Other Medications and UVADEX

Make sure the doctor treating you knows what other medications you are taking, including any, such as paracetamol, that you may have bought for yourself.

UVADEX Use with Food and Drinks

No studies have been conducted to evaluate the effect of food and drinks. As UVADEX is administered as part of a hospital procedure, your specialist doctor will decide if you can eat or drink during a procedure.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor before taking this medication.Do not administer UVADEX if you are pregnant or breastfeeding.

If you are a sexually active woman of childbearing age, during treatment with UVADEX, you should use suitable contraceptive methods because the active ingredient – methoxsalen – may be harmful to a fetus conceived during treatment with UVADEX.

Driving and Operating Machines

You should not drive or operate machines immediately after treatment.

UVADEX contains small amounts of ethanol

This medication contains 217mg of ethanol (alcohol) in each 5.6ml dose, which corresponds to a quantity of 3.1mg/kg per 5.6ml dose. The amount of a 5.6ml dose of this medication is equivalent to less than 6ml of beer or 3ml of wine.

The small amount of alcohol contained in this medication will not have noticeable effects.

UVADEX contains small amounts of sodium

This medication contains less than 23mg of sodium (1mmol) per dose unit; this is essentially "sodium-free."

This medication is always administered by a specialist doctor who can 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 believes it is necessary.

Administration Form

This medication is administered as follows:

A professional with specific training in the use of photopheresis will insert a needle in your arm to extract blood using a specially designed instrument (the THERAKOS CELLEX photopheresis system) and divide it into red blood cells, white blood cells, and plasma. The red blood cells and most of the plasma are simply transfused back into your circulatory system 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 transfused.

Treatment Duration

The procedure takes between three and four hours from the time the needle is inserted until all blood components are transfused back.

You should not receive more than 20 sessions of photopheresis in six months.

During treatment administration and the 24 hours following, you must wear special wraparound sunglasses at all times that prevent UV rays from passing through, to prevent light from damaging your eyes and causing cataract formation.

After Treatment

After receiving treatment, you must 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 SPF sunscreen product, and wear sunglasses (see above).

If You Use More UVADEXThan You Should

This is highly 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 medications, this medication may produce adverse effects, although not all people may experience them.

The following adverse effects have been reported:

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

• Low blood pressure
• Nausea (feeling of dizziness) and vomiting (urge to vomit)
• Infections
• Transient fever (may appear 6-8 hours after treatment)
• Vascular damage (as a result of repeated needle insertion into veins)
• Altered taste

Rare

• Photosensitivity

Unknown frequency (frequency cannot be estimated from available data)

• Allergic reaction

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

UVADEX will be stored in the hospital pharmacy. It should not be stored at a temperature of more than 25° C.

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Composition of UVADEX

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

Appearance of the product and contents of the packaging

Transparent colorless solution.

10 ml amber glass vial with a rubber stopper.

Holder of the marketing authorization and responsible manufacturer

The holder of the product authorization is:

Therakos Europe Ltd,

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

Ireland.

Responsible 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.

Last review date of this leaflet:January 2024.

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/