From the Guidelines
Tacrolimus ointment is not recommended for routine use in children under 2 years of age due to concerns about its safety and potential long-term effects on the developing immune system. The FDA has approved tacrolimus ointment (Protopic) for children 2 years and older, with the 0.03% strength being the only concentration approved for this age group 1. For children under 2, tacrolimus should only be used under the careful supervision of a dermatologist or pediatrician, typically as a short-term treatment for severe eczema that hasn't responded to other therapies.
Key Considerations
- If prescribed, it should be applied as a thin layer to affected areas twice daily until improvement occurs, usually limiting treatment to 2-4 weeks 1.
- Parents should use the minimum amount necessary and avoid covering treated areas with occlusive dressings.
- The caution with tacrolimus in young children stems from its mechanism as a calcineurin inhibitor that suppresses the immune system locally, with theoretical concerns about long-term safety and systemic absorption in infants whose skin barrier is naturally more permeable 1.
Potential Side Effects
- Side effects may include burning sensation, itching, or redness at the application site, which typically diminish with continued use 1.
- There is also a theoretical risk of malignancy associated with the use of topical calcineurin inhibitors, although no evidence of immunosuppressive malignancy has been found in humans 1.
From the Research
Use of Tacrimus Ointment in Children Under 2
- The use of tacrolimus ointment in children under 2 years old has been studied in several research papers 2, 3, 4, 5, 6.
- Atopic dermatitis (AD) is a common eczematous skin condition that affects 10-17% of all children, with 35-60% of affected patients manifesting symptoms during the first year of life 2.
- Treatment principles for AD in young children involve conservative measures, but topical corticosteroids (TCS) are often used, despite the risk of complications such as skin atrophy and systemic absorption 2.
- Tacrolimus ointment has been shown to be effective and safe in the treatment of AD in children younger than 2 years, with no significant adverse effects noted 4.
- A 36-month follow-up study found that topical tacrolimus (0.03% and 0.1%) and topical corticosteroids (mild and moderate potency) are safe to use in young children with moderate to severe AD, and have comparable efficacy and safety profiles 3.
Safety and Efficacy
- The safety and efficacy of tacrolimus therapy in patients younger than 2 years with atopic dermatitis has been demonstrated in several studies 3, 4, 5.
- Tacrolimus ointment has a low potential for systemic accumulation, and analysis of long-term studies indicates that it has a good safety profile 5.
- Systemic drug absorption after tacrolimus ointment application is negligible and unlikely to result in systemic immunosuppression 6.
- There is currently no strong evidence of an increased rate of malignancy in treated patients, and observational data from postmarketing surveillance studies have shown no safety concerns 6.
Treatment Options
- Tacrolimus ointment is an alternative treatment for AD, and can be used as part of maintenance therapy to prevent AD flares 5.
- Treatment with tacrolimus, alone or in combination with topical corticosteroids for acute flares, may be a useful option for long-term management of AD in pediatric patients 5.
- Proactive management of AD with long-term intermittent use of tacrolimus ointment can improve quality of life and reduce the occurrence of AD flares 6.