Safety Profile of Protopic for Moderate to Severe Eczema
Protopic Ointment has an extensively studied safety profile in the treatment of moderate to severe atopic dermatitis (AD). It is not associated with the common risks of conventional prescription steroids. It can be used confidently on difficult to treat areas, such as the face, eyelids, neck, and hands, and on children as young as 2 years.1,2
More than 20,000 eczema patients with moderate to severe eczema, including 8,000 children have been studied,4 including clinical studies lasting more than 3 years. These data demonstrated that treatment with Protopic is safe and effective when used for short-term and non-continuous chronic treatment.
The long-term safety of topical calcineurin inhibitors (TCIs) has not been established (beyond 1 year of non-continuous use):
- Although a causal relationship has not been established, rare cases of malignancy (e.g., skin and lymphoma) have been reported in eczema patients treated with TCIs, including Protopic. Therefore, continuous long-term use of TCIs, including Protopic, in any age group should be avoided and application limited to areas of involvement with AD
- If signs and symptoms of AD do not improve within 6 weeks, patients should be re-examined by their healthcare provider and their diagnosis confirmed
Important Safety Information
Protopic Ointment, both 0.03% and 0.1% for adults and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis (AD) in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for AD or when those treatments are not advisable. Protopic is not indicated for children younger than 2 years of age.