UVADEX 20 micrograms/ml Solution

Contents of the leaflet

1. Package Leaflet: Information for the User
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of Contents of the Package Leaflet:
2. What is Uvadex and what is it used for?
3. Important information before using Uvadex
   1. When not to use Uvadex:
   2. Warnings and precautions
   3. Children
   4. Uvadex and other medicines
   5. Uvadex with food and drink
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Uvadex contains a small amount of ethanol.
   9. Uvadex contains a small amount of sodium.
4. How to use Uvadex
   1. Method of administration
   2. Duration of treatment
   3. After the procedure
   4. Overdose of Uvadex
5. Possible side effects
   1. Reporting side effects
6. How to store Uvadex
7. Package contents and other information
   1. What does Uvadex contain?
   2. What does Uvadex look like and what does the pack contain?
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. Date of last revision of the package leaflet: July 2023

Package Leaflet: Information for the User

Uvadex, 20 micrograms/ml, solution for blood fraction modification
Methoxsalen

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package 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 package leaflet, tell your doctor. See section 4.

Table of Contents of the Package Leaflet:

• 1. What is Uvadex and what is it used for?
• 2. Important information before using Uvadex
• 3. How to use Uvadex
• 4. Possible side effects
• 5. How to store Uvadex
• 6. Package contents and other information

1. What is Uvadex and what is it used for?

The medicine called Uvadex, 20 micrograms/ml, is a solution for modifying blood fractions.
Methoxsalen is a medicine that changes the way the body reacts to light, which becomes active after
exposure to ultraviolet radiation (UV).
Cutaneous T-cell lymphoma (CTCL) is a blood disease that causes abnormal growth of cells that affect
the skin. Uvadex is used with the THERAKOS CELLEX photopheresis system to alleviate skin symptoms of CTCL when
other treatments are not effective.
The THERAKOS CELLEX photopheresis system provides the UV radiation needed to activate methoxsalen, which then destroys the diseased white blood cells.

2. Important information before using Uvadex

When not to use Uvadex:

• If the patient has previously had an allergic reaction to methoxsalen, another psoralen compound, or any of the other ingredients of this medicine.
• If the patient has skin cancer (melanoma, basal cell carcinoma, or squamous cell carcinoma).
• If the patient has a disease that makes them sensitive to light, such as porphyria, systemic lupus erythematosus, or albinism (a condition where the amount of skin pigment is reduced).
• If the patient has had their spleen removed.
• If the patient has blood clotting disorders or a high white blood cell count (above 25,000 per mm).
• If the patient is pregnant or breastfeeding.
• If the patient is sexually active and does not use contraception. Sexually active men or women must use contraception 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, where a large loss of blood is not tolerated.
• If the patient has had a lens removed from one or both eyes.

Warnings and precautions

Before starting Uvadex, discuss with your doctor if you:

• have epilepsy and are being treated with phenytoin (this may make Uvadex therapy ineffective);
• have liver or kidney problems;
• are taking tolbutamide for diabetes (this may increase sensitivity to light);
• have been sunburned before treatment;
• are taking any other medicines that increase sensitivity to light, including certain 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 disorders (e.g., trifluoperazine and haloperidol), and some medicines used to treat skin conditions (e.g., isotretinoin);
• may become pregnant (see above).

Children

Uvadex is not intended for use in children, as there is no sufficient experience available for this age group.

Uvadex and other medicines

Tell your doctor about all medicines you are taking or have recently taken, including those that are available without a prescription, such as paracetamol.

Uvadex with food and drink

No studies have been conducted to assess the effect of food and drink. Since Uvadex is administered as part of a hospital procedure, the decision to eat or drink during the procedure is at the discretion of the specialist doctor.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor for advice before using this medicine. Pregnant or breastfeeding women must not be given Uvadex.
If you are sexually active and of childbearing age, you must use effective contraception during treatment with Uvadex, as the active substance, methoxsalen, may harm a child conceived during treatment with Uvadex.

Driving and using machines

Do not drive or operate machinery immediately after the procedure.

Uvadex contains a small amount of ethanol.

This medicine contains 217 mg of alcohol (ethanol) per 5.6 ml dose, which is equivalent to 3.1 mg/kg body weight per 5.6 ml dose. The amount of alcohol in the 5.6 ml 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 a noticeable effect.

Uvadex contains a small amount of sodium.

This medicine contains less than 1 mmol of sodium (23 mg) per dose unit, which means 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 treatment sessions the patient needs. Most patients receive treatment for 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 received specialized training in photopheresis will insert a needle into a vein in the arm, allowing blood to flow into a specially designed device (the THERAKOS CELLEX photopheresis system), which separates red blood cells, white blood cells, and plasma. The red blood cells and most of the plasma will be returned to the patient's circulation during the procedure.
The white blood cells and the remaining plasma will be mixed with a calculated dose of Uvadex, then exposed to UV radiation in the device, and finally returned to the patient's body.

Duration of treatment

The procedure takes three to four hours from the time the needle is inserted to the time all blood components are returned to the body.
No more than 20 photopheresis sessions can be performed within 6 months.
During the procedure and for 24 hours after, the patient must wear special, wrap-around sunglasses that block UVA radiation to avoid eye damage that can cause cataracts.

After the procedure

After the procedure, avoid sunlight for at least 24 hours, as it can damage the skin, causing sunburn or premature aging of the skin. If the patient must go outside, they should protect their skin with a strong UV filter and wear sunglasses (see above).

Overdose of Uvadex

This is very unlikely, but if too much of the medicine is given, the patient may need to stay in a darkened room for 24 hours or longer.

4. Possible side effects

Like all medicines, Uvadex can cause side effects, although not everybody gets them.
The following side effects have been reported:

• Low blood pressure,
• Nausea (feeling sick) and vomiting,
• Infections,
• Transient fever (may occur 6 to 8 hours after treatment),
• Vein damage (due to repeated needle insertion),
• Taste disturbances.

Uncommon

• Sensitivity to sunlight

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

• Allergic reaction

Reporting side effects

If you experience any side effects, including any not listed in this package leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Al. Jerozolimskie 181C,
02-222 Warsaw,
Phone: 22 49 21 301,
Fax: 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
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 a 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. The expiry date refers to the last day of the month stated.

6. Package contents and other information

What does Uvadex contain?

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

What does Uvadex look like and what does the pack contain?

Clear, colorless solution.
A 10 ml glass vial with a rubber stopper, in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Therakos Europe Ltd,
College Business & Technology Park,
Cruiserath, Blanchardstown,
Dublin 15,
Ireland
[email protected]

Manufacturer

Penn Pharmaceutical Services Limited,
Units 23 & 24 Tafarnaubach Industrial Estate,
Tredegar, Gwent, Wales, NP22 3AA,
United Kingdom
Therakos EMEA Ltd,
College Business & Technology Park,
Cruiserath Road, Blanchardstown,
Dublin 15,
Ireland

Date of last revision of the package leaflet: July 2023