UVADEX 20 MCG/ML Infusion solution

Зміст інструкції

1. UVADEX
   1. What is UVADEX and what is it 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

APPENDIX III
LABELLING AND PACKAGE LEAFLET

• B. PACKAGE LEAFLET

Package leaflet: information for the patient

UVADEX

20 MICROGRAMS/ML
SOLUTION FOR PHOTOFERESIS
(methoxsalen)
Read this leaflet carefully before you start using this medicine as 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 get any side effects, even those not listed in this leaflet, tell your doctor. See section 4.

Contents of the package leaflet:

• 1. What UVADEX is and what it is used for
• 2. What you need to know 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 is UVADEX and what is it used for

The name of the medicine is UVADEX 20 micrograms/ml Solution for the modification of
blood fraction
Methoxsalen is a substance that alters the body's response to light and becomes active following
exposure to UV rays.
Cutaneous T-cell lymphoma (CTCL) is a blood disorder that causes abnormal growth of the
skin. UVADEX is used together with the THERAKOS CELLEX photopheresis System to relieve
skin symptoms of cutaneous T-cell lymphoma when other treatments are ineffective.
The THERAKOS CELLEX photopheresis system provides the UV rays needed to activate the
methoxsalen, which then destroys diseased white blood cells.

2. What you need to know before using UVADEX

Do not use UVADEX if:

• You are allergic to methoxsalen, other psoralen compounds or any of the excipients.
• You have skin cancer (melanoma, basal cell carcinoma or squamous cell carcinoma).
• You suffer from a condition that causes sensitivity to light such as porphyria, systemic lupus erythematosus or albinism (a condition in which skin pigmentation is reduced).
• You have had your spleen removed.
• You have a coagulation disorder or a high white blood cell count (greater than 25,000 per mm).
• You are pregnant or breastfeeding.
• You are sexually active and do not use contraception. Sexually active individuals must use precautions during and after treatment as methoxsalen may harm a child conceived during or after treatment.
• You suffer from a condition that makes you unable to tolerate the withdrawal of large amounts of blood, such as heart disease or severe anemia.
• You have had the crystalline lens removed from one of your eyes.

Warnings and precautions
Talk to your doctor before using UVADEX if:

• You suffer from epilepsy and are currently being treated with phenytoin (which may make treatment with UVADEX ineffective)
• You suffer from LIVER or KIDNEY PROBLEMS
• You are taking tolbutamide for DIABETES (this may cause increased photosensitivity).
• You have been exposed to the sun shortly before treatment.
• You are taking other medicines that cause sensitivity to light, such as some antibiotics (ciprofloxacin, doxycycline and nalidixic acid), diuretics (medicines to promote diuresis), medicines used to treat diabetes (e.g. chlorpropamide), medicines for the treatment of mental illnesses (e.g. trifluoperazine and haloperidol) and medicines used for skin diseases (e.g. isotretinoin).
• You are sexually active and therefore at risk of PREGNANCY (see previous paragraph).

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

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

UVADEX with food and drink
No studies have been conducted to evaluate the effect of food and drink. Given that
UVADEX is administered in a hospital setting, the specialist will decide whether
the patient will be able to eat or drink during the procedure.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy or are breastfeeding with
breast milk, ask your doctor for advice before taking this medicine. It is strictly
forbidden to use UVADEX during pregnancy or breastfeeding.
If you are sexually active and of childbearing potential, you must use suitable contraceptive methods
during treatment with UVADEX, as the active ingredient, methoxsalen, could harm the
child conceived during treatment with this medicine.

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

UVADEX contains small amounts of ethanol.
This medicine contains 405.5 mg of alcohol (ethanol) per 10 ml vial, equivalent to
5.8 mg/kg per dose and 0.001% w/v. The amount of ethanol in 10 ml of the medicine is
equivalent to that of 10.13 ml of beer or 4 ml of wine.
The small amount of alcohol contained in this medicine does not cause noticeable effects.

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

3. How to use UVADEX

This medicine is always administered by a specialist doctor, who will explain the procedure exactly.
The doctor will decide how many sessions are necessary. Most patients
are treated for two consecutive days once a month for six months. If the doctor deems it
appropriate, after four months it is possible to switch to two consecutive days of treatment twice a
month.

Method of administration
The medicine is administered as follows:
A doctor with specific training in the use of photopheresis inserts a needle into the arm, in
order to allow blood to flow into a special instrument (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 transfused back into the circulatory system during the
procedure. The white blood cells and the rest of the plasma are mixed with
a calculated dose of UVADEX, exposed to UV light in the instrument and then reinfused.

Treatment duration
The procedure takes three to four hours from the moment the needle is inserted until the
reinfusion of all blood components.
The patient cannot undergo more than 20 photopheresis sessions in 6 months.
During the administration of the treatment and for the following 24 hours, they must always
wear special wraparound sunglasses that block UVA rays, to prevent the light from damaging the
eyes and causing cataracts.

After treatment
After the treatment has been administered, exposure to sunlight should be avoided for
at least 24 hours, as it may damage the skin causing burns or, in the long term,
premature aging. If the patient is obliged to go out, they must protect their skin, using
a high-protection sunscreen and wearing sunglasses (see above).

If you use more UVADEX than you should
This is an unlikely event. However, if an excessive dosage of the product is used by mistake, the
subject must remain in a dark room for 24 hours or more.

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 the veins (caused by repeated needle insertion into the veins),
• altered taste

Uncommon

• Sensitivity to sunlight

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

• allergic reaction

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your healthcare professional or pharmacist. You can also report side effects directly through the
national reporting system at the web address: 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 at a temperature above
25ºC.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package of
cardboard. The expiry date refers to the last day of that month.

6. Contents of the pack and other information

What does UVADEX contain?

• The active ingredient 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
Clear, colourless solution.
10 ml amber glass vial with a 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

Date of revision of the text