From the Guidelines
Topical tacrolimus is not recommended for infants as young as 15 weeks old due to safety concerns related to systemic absorption and immunosuppression. The most recent guidelines from 2017 1 support the use of topical calcineurin inhibitors, including tacrolimus, in children older than 2 years, but do not provide evidence for its safety in infants as young as 15 weeks. The FDA-approved labeling for tacrolimus ointment also indicates it should only be used in children 2 years and older, with the 0.03% strength being the only concentration approved for pediatric use.
For a 15-week-old infant with skin conditions that might typically warrant tacrolimus, such as atopic dermatitis, low-potency topical corticosteroids would be the preferred first-line treatment under pediatric dermatologist supervision. The safety concern with tacrolimus in very young infants relates to their higher skin surface area to body weight ratio, which could potentially lead to greater systemic absorption and risk of immunosuppression, as noted in earlier reports 1. Additionally, the developing immune system of a 15-week-old makes the immunomodulatory effects of tacrolimus more concerning.
Some key points to consider when treating a 15-week-old infant with skin conditions include:
- Gentle skin care
- Identification and avoidance of triggers
- Possibly short courses of very mild topical steroids (like 1% hydrocortisone) used sparingly on affected areas
- Consultation with a pediatric dermatologist for personalized treatment recommendations.
From the FDA Drug Label
The FDA drug label does not answer the question.
From the Research
Safety of Topical Tacrolimus in 15-Week-Old Infants
- The safety of topical tacrolimus in infants as young as 15 weeks old is not directly addressed in the provided studies, but its use in children is discussed 2, 3, 4, 5, 6.
- Topical tacrolimus is found to be effective in treating moderate to severe atopic dermatitis in children, with minimal systemic absorption and without causing skin atrophy 2, 3, 4.
- The most common side effects are burning and itching, which tend to resolve early in treatment 2, 3, 4, 6.
- Serious adverse events are rare and are considered to be unrelated to the treatment in most cases 4.
- There is no evidence to suggest that topical tacrolimus increases the risk of malignancies or skin atrophy 4, 5.
Efficacy and Tolerability
- Topical tacrolimus is as effective as potent topical corticosteroids in treating atopic dermatitis, and may have a place for long-term use in patients with resistant atopic dermatitis 4, 6.
- Tacrolimus 0.1% is more effective than tacrolimus 0.03% and pimecrolimus 1% in treating atopic dermatitis 4, 6.
- Pimecrolimus and tacrolimus cause significantly more skin burning than topical corticosteroids, but rates of skin infections do not differ 6.
Mechanism of Action
- Tacrolimus works by inhibiting calcineurin, which interrupts cytokine gene expression and leads to the downregulation of T-cell activity 3, 5.
- Tacrolimus has a diverse action on the cardinal pathomechanisms of atopic dermatitis, including mast cell activation, innate allergic response, pruritus, sensory nerve activation, and skin barrier dysfunction 5.