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This information sheet is a short guide to tacrolimus ointment (also known as Protopic). It contains information, which will help in understanding what tacrolimus ointment does, how it works,how it is used and what the possible side effects might be.
Tacrolimus ointment is an ointment applied to the skin. It is not a steroid. Tacrolimus ointment is animmunomodulatory drug, which means it modulates or ‘changes’ the immune system in some way.
Tacrolimus has been used for a few years as a drug taken by mouth to suppress the immunesystem to prevent rejection of kidney transplants. The skin’s immune system is normallyresponsible for protection against things such as infection, but in atopic eczema, it is overactive tosome degree. Tacrolimus helps to suppress this over-activity.
Tacrolimus ointment 0.1% and 0.03% ointment can be used for the treatment of moderate tosevere atopic eczema that is unresponsive to conventional therapy. The ointment is available onprescription only.
Atopic eczema is a skin condition where the body reacts to things in the environment, which wouldnormally do it no harm. This means that the immune system may be fighting things such as thehouse-dust mite and pollen allergens, which in turn cause the skin to become red, itchy andinflamed.
Tacrolimus ointment acts on the cells in the body and the skin to dampen down the immunesystem. This will help to reduce inflammation and make the skin less itchy and red.
Tacrolimus ointment is used for people with atopic eczema and is available in two differentstrengths, 0.03% and 0.1%. It is applied thinly to the skin, twice a day, in the same way in which atopical steroid may be applied. It should only be applied to areas of the skin where there is atopiceczema. The patient information leaflet enclosed in the packaging will explain this in more detail.
Please discuss the application of this ointment with your doctor.
The manufacturers, Fujisawa, indicate its use in the UK is for children over the age of two andadults who have not responded adequately to conventional treatments, for example, if in yourprescribing doctor's opinion, topical steroids fail to work on your eczema.
Topical tacrolimus will be prescribed by dermatologists and doctors who have experience in thetreatment of atopic dermatitis.
Topical tacrolimus can be used on the skin on any part of the body, including the face, exceptmucosa (inside the nose, mouth and internal genital area) Can it be used in combination with other treatments? It is important to always use plenty of emollient as often as possible to keep the skin smooth,supple and well moisturised. Emollients can be used alongside tacrolimus ointment. As topicaltacrolimus works by damping down the immune system, it could worsen skin infections by reducingthe skin's natural resistance. It should not therefore be applied to skin that is infected either withbacteria (e.g. impetigo) or viruses (e.g. chickenpox, cold sores or warts). Tacrolimus is not suitablefor use under wet wraps.
As yet no trials have been undertaken to assess the impact of using tacrolimus at the same timeas other treatments such as topical steroids and antibiotics. Practice will be developed in the lightof better understanding as more research is undertaken and the results become available. It islikely that doctors will use topical tacrolimus alongside topical steroids but on different parts of thebody and it is more than likely that oral antibiotics will be used alongside topical tacrolimus forinfected atopic eczema. Other treatments for severe atopic eczema such as oral steroids orultraviolet light treatment will probably be stopped before a course of tacrolimus ointment isstarted, or tailed off soon after starting the tacrolimus ointment, There have now been a number of trials using tacrolimus ointment to treat atopic eczema; it hasbeen compared to placebo and to 1% hydrocortisone (a very weak topical steroid available overthe counter) and the results look very good when compared against these. More recently it hasbeen compared to hydrocortisone butyrate, which is a potent topical steroid. The results of thisstudy suggest that stronger strength of tacrolimus (0.1%) is as effective at treating atopic eczemaas hydrocortisone butyrate. Hydrocortisone butyrate was more effective than the 0.03% tacrolimusin that study. Even though tacrolimus is being developed for those for whom conventionaltreatment hasn't worked, none of the trials to date have tested tacrolimus with this particular groupof people, so it is difficult to say how well it will work in such people The skin begins to improve in about the first week of using the ointment, with an improvement initching and redness, and this continues whilst treatment carries on. It is important to understandthat topical tacrolimus is not a cure for atopic eczema; it is a new way of controlling the eruption ofatopic eczema.
The trials that have been carried out involving tacrolimus ointment have looked into side effectsand potential side effects and trials are on-going to assess the long-term side effects of this newtreatment. The main short-term side effects identified are a burning feeling on the skin – thisoccurs in around one third to half of all people using it; some itching and some infected hairfollicles (folliculitis). As a patient you should be warned by your doctor about this burningsensation and be prepared to put up with it for a day or two as these symptoms seem to disappearwithin the first few days of using the ointment.
Tests have also been performed to see whether tacrolimus ointment can pass through into theblood stream. It can pass through into the bloodstream, but the risk of this happening to asignificant degree appears to be small. Tests have also been conducted to see whether tacrolimusointment can cause the skin to become thinner. These tests show that this does not happen.
Rarely, skin thinning can occur in people using strong topical steroids for long periods on delicatesites such as the face without a break.
It must be stressed that it is impossible to know what the long term side effects of using tacrolimusointment might be as this treatment has not been available for very long. Studies have begun tomonitor the long-term use of tacrolimus ointment. When drugs similar to tacrolimus are taken bymouth over very many years there is an increased risk of skin cancer occurring, although there isno evidence of this happening in any patients using tacrolimus as an ointment. Patients using long-term tacrolimus ointment on sun-exposed areas should avoid excessive strong sun exposure untilsuch time as the safety of sun exposure with this ointment has been established.
Trials have included children from the age of two upwards. Tacrolimus ointment is available foradults and children aged two years and over.
It is available on prescription only, to patients with moderate to severe atopic eczema, under theguidance and advice of the patient’s doctor or specialist.
Can it be used for other types of eczema? At present tacrolimus ointment has only been licensed to treat people with atopic eczema.
• Tacrolimus ointment has been developed from a treatment used to prevent transplant • 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 • Although it is to be used for people in whom conventional treatment might have failed, it • A burning sensation commonly occurs after applying tacrolimus to the skin. This normally • Tacrolimus does not appear to cause skin thinning which can sometimes occur with strong (potent) topical steroids when used incorrectly • Short term studies suggest that tacrolimus is a safe drug, but far less is known about its For further information please contact the information department at the National Eczema Society.
These details are provided only as a general guide. Individual circumstances differ and theNational Eczema Society does not prescribe, give medical advice or endorse products ortreatments. We hope you will find the notes helpful but they do not replace and should not replacethe essential guidance, which can be given by your doctor.
FS/TAC/July 2002/Ward National Eczema SocietyHill House, Highgate Hill National Eczema Society: A Company Limited by Guarantee. Registered Office: Hill House, Highgate Hill, London, N19 5NA.
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