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Uvadex 20 Micrograms/Ml Solution For Blood Fraction Modification

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UVADEX™ 20 MICROGRAMS/ML

SOLUTION FOR BLOOD FRACTION MODIFICATION

(methoxsalen)

Patient Information Leaflet

Read all of this leaflet carefully before you start using this medicine

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

In this leaflet:

1.    What UVADEX™ is and what it is used for

2.    Before you are given UVADEX™

3.    Administration of UVADEX™

4.    Possible side effects

5.    How to store UVADEX™

6.    Further information

The name of this medicine is UVADEX™

20 micrograms/ml Solution for Blood Fraction Modification

Methoxsalen is a product that alters the response of the body to light which becomes active when it is exposed to UV radiation.

1. What is UVADEX™ and what it is used for?

Cutaneous T-cell lymphoma (CTCL) is a blood disorder causing abnormal growths affecting the skin. UVADEX™ is used in combination with the THERAKOS® CELLEX® or UVAR XTS® Photopheresis System to alleviate the skin symptoms of CTCL, when other treatments have not been effective.

The THERAKOS® CELLEX® and UVAR XTS® photopheresis systems provide the UV light necessary to activate methoxsalen which then destroys diseased white blood cells.

2. Before you are given UVADEX™

Make sure this medicine is suitable for you

UVADEX™ should not be given to certain people. You should not be given UVADEX™ if:

•    If you have had an allergic reaction to methoxsalen, another psoralen compound, or any of the other ingredients.

•    If you have skin cancer (melanoma, basal cell or squamous cell cancer).

•    If you have any disease which involves sensitivity to light such as porphyria, systemic lupus erythematosus or albinism (a condition where the pigment in your skin is reduced).

•    If your spleen has been removed.

•    If you have a blood clotting disorder or an increased white blood cell count (greater than 25,000 mm3).

•    If you are pregnant or breastfeeding.

•    If you are sexually active and do not use contraceptive precautions. If you are a sexually active man or woman, you must use contraceptive precautions both during and after treatment as methoxsalen may harm a baby which is conceived during or after treatment.

•    If you have a condition which makes you unable to tolerate removal of large quantities of blood, such as heart disease or severe anaemia.

•    If you have had the lens removed from either of your eyes.

UVADEX™ should be given with special care to certain people

•    If you have EPILEPSY and are being treated with phenytoin (this may cause UVADEX™ treatment to be ineffective)

•    If you have LIVER or KIDNEY problems

•    If you are taking tolbutamide for DIABETES (this may cause increased photosensitivity)

•    If you have sunbathed recently before treatment

•    If you are taking any other medicine which causes sensitivity to light, including some antibiotics (e.g. ciprofloxacin, docycycline and nalidixic acid, some diuretics (water tablets), some medicines used for treating diabetes (e.g. chlorpropamide), some medicines used to treat mental health problems (e.g. trifluoperazine and haloperidol) and some medicines used to treat skin conditions (e.g. isotretinoin)

•    There is any possibility of you becoming PREGNANT (See previous section).

Warning:

This product contains 5% of ethanol. Each dose contains up to 0.41g of alcohol. This may be harmful for those suffering from liver disease, alcoholism, epilepsy, brain injury or disease as well as for pregnant women and children and may modify or increase the effect of other medicines.

Using other medicines

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

Taking UVADEX™ with food and drink

No studies have been done evaluating the effect of food and drink. Since UVADEX™ is administered as part of a hospital procedure, your specialist doctor will decide whether you may eat or drink during a procedure.

Pregnancy and Breast Feeding

You should not be given UVADEX™ if you are pregnant or breast feeding.

Driving and using machines

You should not drive or operate machinery immediately following treatment.

3. Administration of UVADEX™

This medicine 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 have treatment on two successive days once a month for six months. After four months this may be increased to two successive days twice a month if the doctor thinks it is necessary.

The medicine is administered as follows:

A professional specifically trained in the use of photopheresis will place a needle in your arm so that blood can flow into a specially designed instrument (the THERAKOS® CELLEX® or UVAR XTS® Photopheresis System) and be separated into red blood cells, white blood cells and plasma. The red blood cells and most of the plasma are simply transfused back into your circulation 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 returned to you.

The procedure takes three to four hours from the

time the needle is inserted until all the components of your blood have been returned to you.

You should not have more than 20 photopheresis sessions in 6 months.

During administration of your treatment, and for 24 hours afterwards, you must wear special wraparound UVA-blocking sunglasses all ofthetimeto avoid the light damaging your eyes by causing cataracts to form.

After receiving your treatment you should avoid sunlight for at least 24 hours because it may damage your skin by causing burning or, in the long term, premature ageing. If you must go outside you should cover your skin, use a strong sunblocking agent and wear sunglasses (see above).

If you are given too much UVADEX™

This is very unlikely. However, were you to be given too much you may need to remain in a darkened room for 24 hours or longer as part of your treatment

4.    Possible side effects

Like all medicines UVADEX™ can cause some unwanted effects but these have usually been mild and pass off quickly. Nausea and vomiting have been reported infrequently. Blood tests have shown that UVADEX™ may occasionally cause some small changes in the blood, but these have not produced any clinical symptoms. The changes include decreases in albumin, calcium, haemoglobin, potassium, red blood cell count, and proportion of red cells in the blood.

The photopheresis procedure may result in mild or moderate lowering of blood pressure, fever or local infection or damage to veins as a result of insertion of the needle.

If any of these symptoms become troublesome, or you notice anything else which you don’t understand, discuss this with the doctor or nurse looking after you.

5.    How to store UVADEX™?

•    UVADEX™ will be stored in the hospital pharmacy in a safe place out of the reach of children.

It should not be stored above 25°C.

•    UVADEX™ should not be used after the expiry date on the box.

6. Further Information

What UVADEX™ contains?

UVADEX™ contains 20 micrograms/ml of the active ingredient, methoxsalen. UVADEX™ also contains propylene glycol, ethanol 95%, glacial acetic acid, sodium acetate trihydrate, sodium hydroxide, sodium chloride and water for injections.

What UVADEX™ looks like?

UVADEX™ comes in an amber glass vial with a rubber stopper containing 10 ml of solution.

Marketing Authorisation Holder and Manufacturer

The product licence is held by Therakos (UK) Limited, West Forest Gate, Wellington Road, Wokingham, Berkshire, RG40 2AT, UK. UVADEX™ is manufactured by Penn Pharmaceutical Services Limited, Units 23 & 24 Tafarnaubach Industrial Estate Tredegar, Gwent, Wales, NP22 3AA, UK.

Date of preparation

March 2014

1460286J_UK

LBL50798

PLT533