FACTSHEET

The National Ecze-

ma Society receives
no Government or Tacrolimus Ointment (Protopic®)
Health Service
funding.

The Society relies

entirely on volun- Introduction mally do it no harm. This means that the immune
tary income. system may be triggered by things such as house-
This factsheet is a short guide to tacrolimus oint-
ALL our information ment (also known as Protopic®). It contains infor- dust mites, some foods and pollen allergens. But
is clinically evi- mation that will help in understanding what tacroli- often it is overactive with no obvious allergen that
dence based and mus ointment does, how it works, how it is used can be identified. The skin’s immune system is
written by or veri- and what the possible side effects might be. normally responsible for protection against infec-
fied by dermatology tion. In atopic eczema, the immune system
experts. What is it? (particularly T-cells) is overactive – hence the in-
Tacrolimus ointment is an atopic eczema treatment flammation (redness and itch) in the skin. Tacroli-
that is not a steroid. Tacrolimus is an immune- mus can help to suppress this overactivity by acting
modulatory drug, a topical calcineurin inhibitor, on the T-cells to dampen down the immune system.
Eczema affects 5 which is sometimes referred to as a TCI. ‘Topical’ This will help to reduce inflammation and make the
million children and
means that it is an ointment applied to the skin. skin less itchy and red. The active ingredient in
adults in the UK
‘Calcineurin inhibitor’ means that tacrolimus works tacrolimus is a chemical that acts as a ‘calcineurin
every year.
with the immune system by blocking one of the inhibitor’. Calcineurin is a chemical in the skin that
The National chemicals that can contribute to causing atopic targets T-cells and that triggers reactions in the
Eczema Society is eczema. This is all explained in more detail in the immune system for people with atopic eczema.
the only ‘How does it work’ section below. Tacrolimus works by inhibiting this key chemical.
organisation in the
UK devoted to Tacrolimus ointment is an immune-modulatory How is it used?
improving the drug, which means it modulates or changes the im- Tacrolimus ointment should be used at the first
quality of life for
mune system to reduce skin inflammation. Tacroli- appearance of atopic eczema. It is applied thinly to
people with eczema
mus has been used for many years as a drug taken the skin, twice a day, in the same way in which a
and their carers.
by mouth to suppress the immune system to pre- topical steroid may be applied. It should only be
The Society vent rejection of kidney transplants. applied to areas of the skin where there is active
provides practical
eczema (where there is redness). Tacrolimus should
support and When can tacrolimus ointment be used?
be applied to the skin, including the face affected
information on the Tacrolimus ointment 0.1% and 0.03% can be used in
day-to-day by eczema until the skin is clear (when the redness
adults for the treatment of moderate to severe
management and has gone). It should not be applied to mucous mem-
atopic eczema that is not adequately responsive or
treatment of branes (the nose, mouth and internal genital are-
intolerant to conventional therapy (topical ster-
eczema including: as).
oids). Tacrolimus ointment 0.03% can be used for
Confidential children over 2 years of age who have failed to re- Tacrolimus comes in two strengths (0.1% is stronger
telephone and e- spond adequately to conventional therapy. The and 0.03% is weaker). Adults should start with the
mail Helplines ointment is available on prescription only from your stronger, 0.1% and apply twice a day for six weeks
GP or dermatology specialist. It is often used to and then reduce to the weaker 0.03% for long-term
Factsheets and
information
prevent long-term use of strong steroid creams that use. Children should use the weaker 0.03% twice a
booklets may damage the skin. day from the start of treatment for 3 weeks and
then reduce to once a day until the atopic eczema
Members’ How does it work?
is clear.
information pack Atopic eczema is a skin condition in which the body
and quarterly reacts to things in the environment that would nor-
(Continued on page 2)
magazine.

11 Murray Street, LONDON, NW1 9RE. Helpline: 0800 089 1122 email: helpline@eczema.org www.eczema.org

The manufacturer, Astellas Pharma Ltd, currently indicates
that the use of tacrolimus ointment in the UK is for children
over the age of 2 and adults who have not responded ade-
quately to conventional treatments – for example, if in your
prescribing doctor's opinion topical steroids fail to work on
your atopic eczema. Topical tacrolimus will be prescribed
by dermatologists and doctors who have experience with
such medications.
The patient information leaflet enclosed in the tube packag-
ing will give instructions on using tacrolimus and explain in
more detail. Please discuss the application of this ointment
with your doctor, nurse or pharmacist.
In 2009 the European regulatory bodies approved tacrolimus
ointment to be used twice weekly to prevent eczema flare-
ups. Regular treatment is used until a flare of eczema is bet-
ter and then tacrolimus (0.1% adults, 0.03% children) is ap-
plied just twice per week (e.g. Monday and Thursday nights)
to try to prevent (or lessen the number of) further flares of
eczema. Studies showed this to be effective over a 1year
period.
Can it be used in combination with other treat-
ments?
Yes, tacrolimus can be used in combination with other treat-
ments (on the advice and instruction of your healthcare pro-
fessional) and always with emollients (wash products and
moisturisers) alongside tacrolimus. However, there are some
important rules when using with emollients.
Emollients are very important in atopic eczema treatment
and need to be used every day. Plenty should be used as of-
ten as possible to keep the skin smooth, supple and well
moisturised. The recommendations from the manufacturer
are that emollients should not be used within 2 hours of ap-
plying tacrolimus. Therefore, emollient bath/wash products
and moisturisers should be used and then a gap of 2 hours is
required before tacrolimus is applied.
As topical tacrolimus works by damping down the immune
system, it could worsen skin infections by reducing the skin's
natural resistance. It should not therefore be applied to skin
that is infected either with bacteria (e.g. impetigo) or virus-
es (e.g. chickenpox, cold sores or warts). Tacrolimus is not
suitable for use under wet wraps.
As yet no trials have been undertaken to assess the impact of
using tacrolimus at the same time as other treatments such Does it work?
as topical steroids and antibiotics. Practice will be devel- There have now been a number of trials (clinical research
oped in the light of better understanding as more research is studies) using tacrolimus to treat atopic eczema. It has been
undertaken and the results become available.
FACTSHEET
Tacrolimus and topical steroids should not be used at the
same time on the same areas of the body. However, it is
likely that doctors will use topical tacrolimus alongside topi-
cal steroids on different parts of the body – for example,
tacrolimus may be prescribed for unresponsive facial atopic
eczema and a steroid may continue to be used on the body.
Oral antibiotics may be used alongside topical tacrolimus for
infected atopic eczema.
Due to a theoretical risk of vaccination failure, the manufac-
turer currently advises that any vaccination should be admin-
istered either prior to commencement of treatment with
tacrolimus, or after a tacrolimus-free interval of 2 weeks. In
the case of live vaccines, this should be extended to 28 days.
It is also wise to avoid treatment with topical tacrolimus for
3 weeks after vaccination. In the case of live vaccines, treat-
ment with topical tacrolimus is best avoided for 28 days be-
fore and after vaccination, to avoid the additional theoreti-
cal possibility of an abnormal vaccine infection.
There is no evidence for this advice on vaccinations but the
area has not yet been investigated. It must be remembered
that systemic absorption of the drug in clinical trials is negli-
gible so it seems very unlikely to affect vaccinations.
What else do I need to be aware of?
The main precaution (something you need to be aware of)
for tacrolimus is avoidance of sun and ultraviolet light expo-
sure. Patients using long-term tacrolimus ointment on sun-
exposed areas should avoid excessive strong sun exposure
until such time as the safety of sun exposure with this oint-
ment has been established. This is because when drugs simi-
lar to tacrolimus are taken by mouth over very many years
there is an increased risk of skin cancer occurring, although
there is no evidence of this happening in any patients using
tacrolimus as an ointment (after 8 years of world-wide use).
It is strongly recommended during treatment with tacrolimus
that you try to limit your exposure to natural sunlight. It is
very important that you do not use sun beds or have any oth-
er exposure or treatment with ultraviolet light. This means
that a sunscreen (at least factor 15, with a 5-star UVA rating)
should be used to cover your skin. Direct sunlight, particular-
ly in the hottest part of the day (11.00 am to 3.00 pm)
should be avoided. This is general sun-care advice and chil-
dren’s sun exposure should be limited anyway.
(Continued on page 3)
Page 2

compared to placebo (a dummy drug) and to 1% hydrocorti-
sone (a very weak topical steroid available over the counter)
and the results look very good when compared against these.
More recently, it has been compared to hydrocortisone bu-
tyrate, which is a potent topical corticosteroid. The results
of this study suggest that the stronger strength of tacrolimus
(0.1%) is as effective at treating atopic eczema as hydrocor-
tisone butyrate.
Hydrocortisone butyrate was more effective than the 0.03%
tacrolimus in that study. Even though tacrolimus is being
developed for those for whom conventional treatment hasn't
worked, none of the trials to date have tested tacrolimus
with this particular group of people, so it is difficult to say
how well it will work on them.
The skin begins to improve in about the first week of using
the ointment, with an improvement in itching and redness,
and this continues whilst treatment carries on.
It is important to understand that topical tacrolimus is not a
cure for atopic eczema – it is a new way of controlling the
eruption of atopic eczema.
What are the side effects?
The trials that have been carried out involving tacrolimus
ointment have looked into potential side effects and trials
are ongoing to assess the long-term side effects of this rela-
tively new treatment. The main short-term side effects iden-
tified are an irritating, burning feeling on the skin and itch-
ing where tacrolimus is applied – this is estimated to occur in
around one-third to one-half of all people using it. As a pa-
tient you should be warned by your doctor or nurse about
this burning sensation and be prepared to put up with it for a
day or two as these symptoms seem to disappear within a
week of using the ointment.
Other side effects include some increased skin redness, a
sensation of warmth on the area of application and ‘pins and 
needles’. Drinking alcohol is allowed but some people expe-
rienced increased skin irritation and facial flushing during
tacrolimus treatment. A few people also experienced 
blocked skin pores (folliculitis), an increase in spots (acne)
and cold sores (herpes viral infections).
Tests have also been performed to see whether tacrolimus
ointment can pass through into the blood-stream. However,

the risk of this happening to a significant degree appears to
be very small. Tests have also been conducted to see wheth-
er tacrolimus ointment can cause the skin to become thin-
ner. The tests show that this does not happen. Rarely, skin
thinning can occur in people using strong topical steroids for
FACTSHEET
long periods on the body – and more so in delicate areas such
as the face – without a break.
At present it is impossible to know what the long-term side
effects of using tacrolimus ointment for many years might
be, as this treatment has been available for around 10 years.
In 2009, a long-term safety study of patients who had been
using tacrolimus for 4 years concluded that no increased risk
of infections or cancers was associated with long-term use.
How long does a tube of tacrolimus last and how
do I store it?
Tacrolimus should be stored at temperatures below 25˚C and
must not be frozen. Tacrolimus has a 3-year shelf life and
will expire after this time.
Can anyone use it?
Tacrolimus ointment is available for adults and children aged
2 years and over. It is available on prescription only to pa-
tients with moderate to severe atopic eczema, under the
guidance and advice of the patient’s doctor or specialist.
Tacrolimus is used for short-term and intermittent long-term
treatment of atopic eczema that has not adequately re-
sponded to (or is intolerant to) conventional treatments,
namely topical steroids.
Can it be used for other types of eczema?
At present tacrolimus ointment has only been licensed to
treat adults and children (over 2 years of age) with atopic
eczema.
Summary
 Tacrolimus ointment has been developed from a treat-
ment used to prevent transplant rejections. A number
of short-term studies suggest that it is effective when
compared against placebo for children and adults with
atopic eczema.
It seems to be better than 1% hydrocortisone ointment
(a weak topical steroid).
The stronger preparation (0.1%) appears to be as good
as a strong topical steroid.
 Both were more effective than the 0.03% strength of
tacrolimus.
The National Institute for Clinical Excellence (NICE)
recommendation is that tacrolimus is to be used for
people in whom conventional treatment is not ade-
quate or has failed.
(Continued on page 4)
Page 3

Further information
Eczema Helpline
0800 089 1122
(Mon-Fri 8am to 8pm)
Email
helpline@eczema.org
To join NES call 020 7281
3553 (Mon-Fri) 9am to
5.30pm), email:
info@eczema.org
or join online at:
www.eczema.org
These details are provided only as a general guide. Individual circumstances differ and the National Eczema Society does not prescribe, give med-
ical advice or endorse products or treatments. We hope you will find the information useful, but it does not replace and should not replace the
essential guidance given by your general practitioner, dermatologist and dermatology nurse.
The National Eczema Society is a charity registered with the Charity Commission for England and Wales (number 1009671) and a company limited
FACTSHEET
 A burning sensation commonly occurs after panies, based on their research trials and product
applying tacrolimus to the skin. This nor- knowledge and approved by the UK product licens-
mally settles after a week. ing authority called the Medicines and Healthcare
products Regulatory Agency (MHRA).The website
 Tacrolimus does not appear to cause skin address is www.medicines.org.uk
thinning, which sometimes occurs with
strong (potent) topical steroids when used NICE is the independent organisation responsible
incorrectly. for providing national guidance on the promotion
of good health and the prevention and treatment
 Short-term studies are favourable for tacro- of ill health. The NICE guidance on tacrolimus can
limus. In the medium term, tacrolimus ap- be accessed at: http://guidance.nice.org.uk/
pears to be free of long-term risk. But far TA82/Guidance
less is known about its long-term effects on
the immune system.
The National Eczema Society is grateful to Dr Da-
Further information
As well as the patient information leaflet con- vid Paige, Consultant Dermatologist, Barts and
tained in the box with your tacrolimus tube, you the Royal London for reviewing and updating this
may wish to find out more by visiting the electron- fact sheet.
ic Medicines Compendium (eMC) and the NICE Reviewed and updated March 2011
websites.
The eMC is continuously updated and contains in-
formation about all prescription medicines. If you
search for tacrolimus, you will find a full summary
of the product characteristics (SPC) and patient
information leaflet (PIL). These documents are
written and updated by the pharmaceutical com-
Disclaimer
©National Eczema Society 2011
by guarantee (registered in England, number 2685083).