Uvadex 20 micrograms/ml solution for modification of blood fraction

Patient Information Leaflet

Uvadex 20 micrograms/ml solution for modifying blood components
Methoxsalen
Please read all of this leaflet before using this medicine, as it contains important information
for you.

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

Leaflet Contents

1. What Uvadex is and what it is used for
2. Before you use 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

Uvadex 20 micrograms/ml is a solution for modifying blood components.
Methoxsalen is a medicine that alters the way the body reacts to light and becomes active when exposed to ultraviolet (UV) radiation.
Cutaneous T-cell lymphoma (CTCL) is a blood disorder causing abnormal proliferation of cells that affect the skin. Uvadex is used with the THERAKOS CELLEX Photopheresis System to alleviate cutaneous symptoms of CTCL when other treatments have not been effective.
The THERAKOS CELLEX Photopheresis System delivers UV radiation required to activate methoxsalen, which then destroys abnormal white blood cells.

2. Important information before using Uvadex

When not to use Uvadex

• If the patient has previously experienced an allergic reaction to methoxsalen, another psoralen compound, or any of the other ingredients of this medicine.
• If the patient suffers from a condition associated with photosensitivity, such as porphyria, systemic lupus erythematosus, or albinism (a condition in which skin pigment is reduced).
• If the patient has had their spleen removed.
• If the patient has blood clotting disorders or an elevated white blood cell count (above 25,000 per mm³).
• If the patient is pregnant or breastfeeding.
• If the patient is sexually active and not using contraception. Men or women who are sexually active must use contraceptive methods both during and after treatment, as methoxsalen may harm a child conceived during or after treatment.
• If the patient has severe heart disease or severe anemia, when loss of a large amount of blood is not tolerated.
• If the patient has had the lens removed from or has a lens implant in either eye.

Warnings and precautions
Before starting treatment with Uvadex, discuss with the doctor if:

• the patient has EPILEPSY and is being treated with phenytoin (this may make treatment with Uvadex ineffective);
• the patient has SKIN CANCER (melanoma, basal cell carcinoma, or squamous cell carcinoma);
• the patient has LIVER or KIDNEY disease;
• the patient is taking tolbutamide for DIABETES (this may increase sensitivity to light);
• the patient has been sunbathing prior to treatment;
• the patient is taking any other medicines that increase sensitivity to light, including certain antibiotics (e.g. ciprofloxacin, doxycycline, and nalidixic acid), some diuretics, certain medicines used to treat diabetes (e.g. chlorpropamide), some medicines used to treat psychiatric disorders (e.g. trifluoperazine and haloperidol), and some medicines used to treat skin conditions (e.g. isotretinoin);
• there is any possibility that the patient may be PREGNANT (see previous point).

Children
Uvadex is not intended for use in children, as there is insufficient experience available for this age group.

Uvadex with other medicines
Inform the doctor about all medicines currently taken or recently used by the patient.
This includes medicines available without a prescription, such as paracetamol.

Uvadex with food and drink
No studies have been conducted to assess the effects of food and drink. Uvadex is administered as part of a hospital procedure; therefore, the decision on whether the patient may eat or drink during the procedure is at the discretion of the specialist doctor.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor before using this medicine. Pregnant women or those who are breastfeeding must not receive Uvadex.
If the patient is sexually active and of reproductive age, she must use appropriate contraceptive methods during treatment with Uvadex, as the active substance, methoxsalen, may harm a child conceived during treatment with Uvadex.

Driving and operating machinery
Immediately after completion of the procedure, patients should not drive or operate machinery.

Uvadex contains a small amount of ethanol
This medicine contains 217 mg of alcohol (ethanol) in each 5.6 ml dose, equivalent to 3.1 mg/kg body weight for a 5.6 ml dose. The amount of alcohol in a 5.6 ml volume 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 cause noticeable effects.

Uvadex contains a small amount of sodium
The medicine contains less than 1 mmol (23 mg) of sodium per dose unit, meaning the medicine is considered "sodium-free".

3. How to use Uvadex

This medicine is always administered by a specialist doctor who can explain what is happening. The doctor will decide how many therapeutic procedures the patient needs. Most patients receive treatment on two consecutive days, once a month, for six months. After four months, the 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 doctor who has undergone specialist training in photopheresis will insert a needle into a vein in the arm so that blood can flow into a specially designed device (the THERAKOS CELLEX photopheresis system), which separates red blood cells, white blood cells, and plasma. During the procedure, red blood cells and most of the plasma will be returned to the patient's circulatory system. The white blood cells and the remaining plasma will be mixed with a calculated dose of Uvadex, then exposed to UV radiation within the device, and finally reinfused back into the patient's body.

Duration of treatment
The procedure lasts from three to four hours, starting from the moment the needle is inserted until all blood components are returned to the body.
No more than 20 photopheresis sessions may be performed within a 6-month period.

During the procedure and for 24 hours after its completion, the patient must wear special, UV-A-blocking goggles with a protective strap to prevent eye damage from light exposure, which could lead to cataracts.

After the procedure
After undergoing the procedure, the patient should avoid sunlight for at least 24 hours, as sunlight may damage the skin, causing sunburn or, over time, premature skin aging. If the patient needs to go outdoors, the skin should be protected with a high-protection UV sunscreen and sunglasses should be worn (see above).

Administration of a higher than recommended dose of Uvadex
This is very unlikely, but if an overdose is administered, it may be necessary to remain in a darkened room for 24 hours or longer as part of the treatment.

4. Possible adverse reactions

Like all medicinal products, this medicine can cause adverse reactions, although not everybody will experience them.
The following adverse reactions have been reported:

Common (may occur in up to 1 in 10 patients):

• low blood pressure,
• nausea and vomiting,
• infections,
• transient fever (may occur 6 to 8 hours after treatment),
• damage to veins (due to repeated needle insertion into veins),
• taste disturbances.

Uncommon:

• increased sensitivity to sunlight.

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

• allergic reaction.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C,
PL-02 222 Warsaw,
Tel.: + 48 22 49 21 301,
Fax: + 48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Uvadex

Uvadex is stored in a hospital pharmacy. Do not store above 25°C.
The medicine should be kept 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 the stated month.

6. Contents of the pack and other information

What Uvadex contains

• The active substance is methoxsalen.
• One 10 ml vial contains 200 micrograms (µg) of methoxsalen. One millilitre of solution contains 20 micrograms of methoxsalen.
• The other ingredients are: propylene glycol, 95% ethanol, glacial acetic acid, sodium acetate trihydrate, sodium hydroxide 1 N, sodium chloride, and water for injections.

What Uvadex looks like and contents of the pack
Clear, colourless solution.
A 10 ml vial made of amber type 1 glass, closed with a rubber stopper, contained in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Therakos Europe Ltd,
College Business & Technology Park,
Cruiserath, Blanchardstown,
Dublin 15,
Ireland
[email protected]
Manufacturer/Importer
Therakos EMEA Ltd,
College Business & Technology Park,
Cruiserath Road, Blanchardstown,
Dublin 15,
Ireland