1. Dosage

Topical calcineurin inhibitors are FDA-approved as second-line agents for atopic dermatitis management in non-immunocompromised adults and children greater than 2 years of age who have not responded to other available therapies for atopic dermatitis. Pimecrolimus (Elidel®) is indicated for short-term, intermittent treatment of mild-to-moderate atopic dermatitis, while tacrolimus (Protopic®) is indicated for short-term, intermittent therapy of moderate-to-severe atopic dermatitis1-4.

Due to the uncertainty of the carcinogenic risk, the FDA issued a Black Box Warning for topical calcineurin inhibitors in 2006 stating that rare cases of malignancy have been reported, continuous long-term use should be avoided, and application should be limited to areas of the body with atopic dermatitis. Additionally, topical calcineurin inhibitors are not indicated for use in children less than 2 years of age1-6.

1.1. Adults

Dosage recommendations for available calcineurin inhibitors are summarized in Table 11-4.

Patient profiles documenting prescriptions for greater than the equivalent of one 60 g tube of pimecrolimus cream or tacrolimus ointment per 30-day time period will be reviewed.

Table 1: Recommended Adult Dosages for Topical Calcineurin Inhibitors

Drug Name Dosage Strength Recommended Dose/Directions
pimecrolimus (Elidel®, generics) cream 1% - 30 g, 60g, 100 g tube apply thin layer of cream to affected area twice daily until symptoms resolve; use should be confined only to areas affected by atopic dermatitis; should not be used with occlusive dressings
tacrolimus (Protopic®, generics) ointment
  • 0.03% - 30 g, 60 g, 100 g tube
  • 0.1% - 30 g, 60 g, 100 g tube
 apply thin layer of 0.03% or 0.1% ointment to affected area twice daily, rubbing in completely, and continue until symptoms resolve; use should be confined only to areas affected by atopic dermatitis; should not be used with occlusive dressings

1.2. Pediatrics

A Black Box Warning states that the long-term safety of topical calcineurin inhibitors has not been established, and continuous long-term use is not recommended. While a causal relationship for the incidence of malignancy has not been established, topical calcineurin inhibitor use should be avoided in children younger than 2 years of age as the effect on the developing immune system is not known1-6.

Recommended pediatric dosages for topical calcineurin inhibitors are summarized in Table 21-4.

Table 2: Recommended Pediatric Dosages for Topical Calcineurin Inhibitors

Drug Name/Strength Recommended Dose/Directions
pimecrolimus 1% cream Children greater than 2 years of age: apply thin layer of cream to affected area twice daily until symptoms resolve; use should be confined only to areas affected by atopic dermatitis; should not be used with occlusive dressings

tacrolimus 0.03% ointment

tacrolimus 0.03% or 0.1% ointment
  • Children 2-15 years of age: use only 0.03% strength; apply thin layer of ointment to affected layer twice daily, rubbing in completely, and continue until symptoms resolve; use should be confined only to areas affected by atopic dermatitis; should not be used with occlusive dressings
  • Children 15-17 years of age: apply thin layer of 0.03% or 0.1% ointment to affected area twice daily, rubbing in completely, and continue until symptoms resolve; use should be confined only to areas affected by atopic dermatitis; should not be used with occlusive dressings