Atopic Dermatitis Knowledge Centre
Topical calcineurin inhibitors
PROTOPIC™ - Frequently Asked Questions
Mechanism of Action | Efficacy and safety | FAQ
How can application site irritation be reduced?
Application site irritation is a common side-effect on initial treatment with PROTOPIC. The patient should be fore-warned that this may occur, that it is a normal reaction to the treatment and not to be alarmed. As the skin heals, less of the active ingredient will penetrate the skin so the irritation will naturally lessen with time. The patient should be advised to persist with treatment for a least one week, if possible, and to return for reassessment if they experience no alleviation of application site irritation after this time.
How should alcohol flush be managed?
The patient should also be advised that they could experience facial flushing or skin irritation after drinking alcohol. Again, they should be reassured not to worry if they do experience alcohol flush and advised that this can usually be managed by reducing or eliminating alcohol intake. The patient should be asked to return if they find this is a persistent or particularly bothersome side-effect.
Is there a maximum period of time or dosage allowed for twice-weekly treatment with PROTOPIC?
PROTOPIC ointment (0.1% concentration for adults; 0.03% for children aged ≥2 years) should be applied once a day, twice weekly (i.e. the patient should have 2–3 treatment-free days between each application). There is no data available for proactive disease control with PROTOPIC beyond 12 months. Therefore, the patient should be reassessed after 1 year of twice-weekly treatment. In children, this reassessment should include suspension of the twice-weekly treatment to review whether the need to continue treatment still exists.
Why is it advisable not to sunbathe or undergo UVA or UVB phototherapy while using PROTOPIC and how should patients manage this when in a sunny climate?
Although there have been no studies in humans which have directly investigated adverse reactions of UV exposure during topical PROTOPIC treatment in humans, avoiding sunbathing or UV therapy is considered to be a standard precaution in general and when using active topical treatments in particular. The patient should be advised to limit their exposure to UV radiation by taking a number of sensible precautions when in a sunny climate: wearing loose clothing that covers areas of the skin treated with PROTOPIC (e.g. long sleeves to cover their arms), staying in the shade where possible during intense periods of sunlight (e.g. between 11 am and 3 pm) and using a high-factor sun-cream. There is no evidence of any sun-cream reacting with PROTOPIC (as with application of emollient preparations – see below – it would be advisable to allow 2 hours between treatment of PROTOPIC and application of any other skin cream including sun-cream).20
Is it possible to combine treatment with PROTOPIC and topical corticosteroids?
No formal clinical trials or scientific studies have been carried out to investigate the safety of combined treatment as tacrolimus ointment was specifically developed as a monotherapy. For these reasons, it is not advisable to combine PROTOPIC treatment with other active anti-inflammatory topical therapies for atopic dermatitis.
What are the recommendations regarding vaccination while on long-term treatment with PROTOPIC?
Should the patient require a vaccination during PROTOPIC treatment, it is advised that they take a break from treatment for at least 14 days (or 28 days for live, attenuated vaccines) before receiving the vaccine. This recommendation is made as the effect of tacrolimus ointment application during vaccination has not been investigated in clinical trials. Hofman et al have previously demonstrated that the application of tacrolimus ointment does not affect the generation of immune memory or humoral and cell-mediated immunity after immunisation with a meningococcal polysaccharide vaccine.43
References:
20. PROTOPIC – Summary of Product Characteristics. Available from: http:/anti-infectives/Paris-Event/Live-Webcast.cfmwww.emea.europa.eu/humandocs/PDFs/EPAR/protopic/emea-combined-h374en.pdf [Accessed December 2009].
43. Hofman T, Cranswick N, Kuna P, et al. Tacrolimus ointment does not affect the immediate response to vaccination, the generation of immune memory, or humoral and cell-mediated immunity in children. Arch Dis Child 2006; 91: 905–10.
(Unless otherwise stated all trademarks are owned by Astellas Pharma Inc. and/or its related entities)
© February 2010 Astellas Pharma Europe LTD.
Disclaimer:
The Atopic Dermatitis Knowledge centre contained within www.epgonline.org and available at www.atopicdermatitisinfo.org is intended to be for educational use only and not designed to provide medical advice or professional services.