UVADEX

Package leaflet: Information for the patient

UVADEX

20 MICROGRAMS/ML
SOLUTION FOR THE MODIFICATION OF BLOOD FRACTIONS
(methoxsalen)
Please read this leaflet carefully before using this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor. See section 4.

What this leaflet contains:

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 side 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 the medicinal product is UVADEX 20 micrograms/ml Solution for the modification of
blood components.
Methoxsalen is a substance that alters the body's response to light and becomes active upon
exposure to ultraviolet (UV) radiation.
Cutaneous T-cell lymphoma (CTCL) is a blood disorder causing abnormal skin growth. UVADEX is used in combination with the THERAKOS CELLEX Photopheresis System to relieve cutaneous symptoms of cutaneous T-cell lymphoma when other treatments have failed.
The THERAKOS CELLEX Photopheresis System provides the UV radiation required to activate methoxsalen, which then destroys the diseased white blood cells.

2. What you need to know before using UVADEX

Do not use UVADEX if:

• You are allergic to methoxsalen, to other psoralens, or to any of the excipients.
• You have a condition causing light sensitivity such as porphyria, systemic lupus erythematosus, or albinism (a condition in which skin pigment is reduced).
• You have undergone splenectomy (removal of the spleen).
• You have a coagulation disorder or elevated white blood cell count (above 25,000 per mm³).
• You are pregnant or breastfeeding.
• You are sexually active and not using contraception. Sexually active individuals must take contraceptive precautions during and after treatment, as methoxsalen may harm a child conceived during or after treatment.
• You have a condition that makes you unable to tolerate the removal of large volumes of blood, such as heart disease or severe anemia.
• You have undergone lens extraction (aphakia) in one or both eyes.

Warnings and precautions

Talk to your doctor before using UVADEX if:

• You have EPILEPSY and are currently being treated with phenytoin (which may render UVADEX treatment ineffective).
• You have SKIN CANCER (melanoma, basal cell carcinoma, or squamous cell carcinoma).
• You have LIVER or KIDNEY problems.
• You are taking tolbutamide for DIABETES (this may increase photosensitivity).
• You have been exposed to sunlight shortly before treatment.
• You are taking other medicines that cause light sensitivity, such as certain antibiotics (ciprofloxacin, doxycycline, and nalidixic acid), diuretics (medicines to increase urine production), medicines used to treat diabetes (e.g. chlorpropamide), medicines for mental illnesses (e.g. trifluoperazine and haloperidol), or medicines used for skin disorders (e.g. isotretinoin).
• You are sexually active and therefore at risk of PREGNANCY (see section above).

Children
Do not administer UVADEX to children, as there is insufficient experience regarding its use in this age group.

Other medicines and UVADEX
You must inform your physician if you are taking any other medicines, including over-the-counter medications such as paracetamol.

UVADEX with food and drinks
There are no known studies evaluating the effects of food or drinks. Since UVADEX is administered as part of a hospital procedure, the specialist will determine whether the patient may eat or drink during the procedure.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before taking this medicine. The use of UVADEX is strictly contraindicated during pregnancy and breastfeeding.
If you are sexually active and of reproductive age, you must use effective contraceptive methods during treatment with UVADEX, as the active substance, methoxsalen, could harm a child conceived during treatment with this medicine.

Driving and using machines
It is strictly forbidden to drive or operate machinery immediately after treatment.

UVADEX contains small amounts of ethanol.
This medicine contains 217 mg of alcohol (ethanol) per 5.6 ml dose, equivalent to 3.1 mg/kg per 5.6 ml dose. The amount of ethanol in a 5.6 ml dose is equivalent to less than 6 ml of beer or 3 ml of wine.
The small amount of alcohol contained in this medicine does not have any noticeable effects.

UVADEX contains small amounts of sodium.
This medicine contains less than 1 mmol of sodium (23 mg) per dose, meaning it is essentially "sodium-free".

3. How to use UVADEX

This medicine is always administered by a specialist doctor, who will explain the procedure in detail. The doctor will decide how many treatment sessions are required. Most patients are treated for two consecutive days once a month for six months. If considered appropriate by the doctor, after four months the treatment may be changed to two consecutive days of treatment twice a month.

Method of administration
The medicine is administered as follows:
A doctor trained specifically in the use of photopheresis inserts a needle into the arm to draw blood into a dedicated 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 returned to the 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 within the device, and then reinfused.

Duration of treatment
The procedure takes three to four hours, from insertion of the needle until reinfusion of all blood components.
The patient must not receive more than 20 photopheresis sessions within 6 months.
During treatment administration and for 24 hours afterwards, the patient must always wear special wrap-around sunglasses that block UVA radiation, to prevent light-induced eye damage and cataract formation.

After treatment
After receiving treatment, exposure to sunlight must be avoided for at least 24 hours, as it may damage the skin, causing burns or, over the long term, premature aging. If the patient must go outdoors, the skin must be protected by using a high-protection sunscreen and wearing sunglasses (see above).

If you use more UVADEX than you should
This is unlikely to occur. However, if an excessive dose of the product is accidentally used, the patient must remain in a dark room for 24 hours or longer.

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 unwell) and vomiting,
• infections,
• transient fever (may occur 6 to 8 hours after treatment),
• damage to veins (caused by repeated insertion of a needle into veins),
• altered taste.

Uncommon:

• sensitivity to sunlight.

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

• allergic reaction.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your healthcare provider. You may also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store UVADEX

UVADEX is stored in the hospital pharmacy. Do not store above 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month.

6. Package contents and other information

What UVADEX contains

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

Description of the appearance of UVADEX and contents of the pack
Colourless, clear solution.
10 ml amber glass vial with rubber stopper.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: THERAKOS EUROPE LTD, College Business & Technology Park, Cruiserath, Blanchardstown, Dublin 15, Ireland
Manufacturer: Penn Pharmaceutical Services Limited, Units 23 & 24 Tafarnaubach Industrial Estate, Tredegar, Gwent, Wales, NP22 3AA, United Kingdom.
or
Therakos EMEA Ltd, College Business & Technology Park, Cruiserath Road, Blanchardstown, Dublin 15, Ireland