Crisaborole

Based on in vitro data, concomitant administration of crisaborole and CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, erythromycin, clarithromycin, ritonavir) or CYP1A2 inhibitors (e.g., ciprofloxacin, fluvoxamine) can increase systemic crisaborole concentrations.

Crisaborole ointment has not been evaluated in combination with other cutaneous medicinal products used to treat mild to moderate atopic dermatitis and co-application on the same skin areas is not recommended. Emollients may be used on other areas of skin not affected by atopic dermatitis; co-application of emollients with crisaborole on the same skin areas is not recommended.

There are no or limited amount of data from the use of crisaborole in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of crisaborole during pregnancy.

Animal studies on milk excretion after topical application were not conducted. Crisaborole is systemically absorbed. It is unknown whether crisaborole or its metabolites or excipients are excreted in human milk following topical application of the ointment or has an effect on human milk production. The lack of clinical data during breast-feeding precludes a clear determination of the risk of crisaborole to a breastfed infant. Therefore, because of the potential for adverse reactions in breastfed infants, crisaborole should not be used in breast-feeding women.

Fertility

Reproduction studies in male or female rats using oral administration of crisaborole revealed no effects on fertility.

Crisaborole has no or negligible influence on the ability to drive and use machines.

Summary of the safety profile

The most common adverse reactions are application site reactions (6.0%), including application site pain, e.g., burning or stinging (4.4%). Generally, application site pain was noted early in the treatment period and was transient in nature, resolving spontaneously.

Tabulated list of adverse reactions

Adverse reactions are ranked under headings of frequency, with the most frequent first, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).

Adverse reactions:

¹ Refers to skin sensations such as burning or stinging.