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UVADEX 20 MICROGRAMS/ML SOLUTION FOR BLOOD FRACTION MODIFICATION

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20 micrograms/ml Solution for Blood
Fraction Modification
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?

Important Information
Professional Leaflet

UVADEX®
20 MICROGRAMS/ML
SOLUTION FOR BLOOD FRACTION
MODIFICATION
(methoxsalen)
Patient Information Leaflet

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.

Read all of this leaflet carefully before you
start using this medicine
You should not be given UVADEX® if:
- Keep this leaflet. You may need to read
it again.
• If you have had an allergic reaction
- If you have any further questions, ask
to methoxsalen, another psoralen
your doctor.
compound, or any of the other
- If any of the side effects gets serious, or
ingredients.
if you notice any side effects not listed
in this leaflet, please tell your doctor.
• If you have skin cancer (melanoma,
basal cell or squamous cell cancer).
In this leaflet:
1. What UVADEX is and what it is used for • If you have any disease which involves
2. Before you are given UVADEX
sensitivity to light such as porphyria,
3. Administration of UVADEX
systemic lupus erythematosus or
4. Possible side effects
albinism (a condition where the
5. How to store UVADEX
pigment in your skin is reduced).
6. Further information
The name of this medicine is UVADEX®

• 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 breast feeding.
• 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
YOUR DOCTOR will advise you whether
you can receive treatment with UVADEX®
if:
• 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

This is very unlikely. However, were you
What UVADEX looks like?
to be given too much you may need to
remain in a darkened room for 24 hours or UVADEX® comes in an amber glass vial
with a rubber stopper containing 10 ml of
longer as part of your treatment.
solution.
4. Possible side effects
Marketing Authorisation Holder and
Like all medicines UVADEX® can cause
Manufacturer
The medicine is administered as follows:
some unwanted effects but these have
The product licence is held by THERAKOS
usually been mild and pass off quickly.
A professional specifically trained in the
Nausea and vomiting have been reported (UK) Limited, 3 Lotus Park, The Causeway,
use of photopheresis will place a needle
infrequently. Blood tests have shown that Staines-upon-Thames, Surrey TW18 3AG,
in your arm so that blood can flow into
United Kingdom.
UVADEX® may occasionally cause some
a specially designed instrument (the
small changes in the blood, but these have
THERAKOS™ CELLEX™ or UVAR® XTS
UVADEX® is manufactured by Penn
not produced any clinical symptoms. The
Photopheresis System) and be separated
Pharmaceutical Services Limited, Units
into red blood cells, white blood cells and changes include decreases in albumin,
23 & 24 Tafarnaubach Industrial Estate
calcium, haemoglobin, potassium, red
plasma. The red blood cells and most of
Tredegar, Gwent, Wales, NP22 3AA, United
blood cell count, and proportion of red
the plasma are simply transfused back
Kingdom.
into your circulation during the procedure. cells in the blood.
The white blood cells and the rest of the
Date of preparation
The photopheresis procedure may result
plasma are mixed with a calculated dose
in mild or moderate lowering of blood
of UVADEX®, exposed to UV light in the
January 2017.
pressure,
fever
or
local
infection
or
instrument, and then returned to you.
damage to veins as a result of insertion of
The procedure takes three to four hours
the needle.
from the time the needle is inserted until
If any of these symptoms become
all the components of your blood have
troublesome, or you notice anything else
been returned to you.
which you don't understand, discuss this
You should not have more than 20
with the doctor or nurse looking after you.
photopheresis sessions in 6 months.
5. How to store UVADEX?
During administration of your treatment,
• UVADEX® will be stored in the hospital
and for 24 hours afterwards, you must
pharmacy in a safe place out of the
wear special wrap-around UVA-blocking
reach of children. It should not be
sunglasses all of the time to avoid the light
stored above 25ºC.
damaging your eyes by causing cataracts

UVADEX® should not be used after the
to form.
expiry date on the box.
After receiving your treatment
6. Further Information
After receiving your treatment you
What UVADEX contains?
should avoid sunlight for at least 24
hours because it may damage your skin
UVADEX® contains 20 micrograms/ml
by causing burning or, in the long term,
of the active ingredient, methoxsalen.
premature ageing. If you must go outside
UVADEX® also contains propylene glycol,
you should cover your skin, use a strong
ethanol 95%, glacial acetic acid, sodium
sunblocking agent and wear sunglasses
acetate trihydrate, sodium hydroxide,
(see above).
sodium chloride and water for injections.
If you are given too much UVADEX
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.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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