Indicated for topical treatment of mild to moderate atopic dermatitis in patients 2 years of age and older
Phosphodiesterase 4 inhibitor
The active ingredient, Crisaborole, is a phosphodiesterase-4 (PDE-4) inhibitor, mainly acting on phosphodiesterase 4B (PDE4B), which causes inflammation. Chemically, Crisaborole is a phenoxybenzoxaborole. It contains a boron atom that helps penetrate the skin and is essential for its binding activity. Inhibition of PDE4B appears to suppress the release of tumor necrosis factor alpha (TNFα), interleukin-12 (IL-12), IL-23 and other cytokines, proteins believed to be involved in the immune response and inflammation.
Apply a thin layer twice daily to affected areas. ? For topical use only. ? Not for ophthalmic, oral, or intravaginal use.
In vitro studies using human liver microsomes indicated that under the conditions of clinical use, Crisaborole and metabolite 1 are not expected to inhibit cytochrome P450 (CYP) 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, and 3A4. In vitro human liver microsomes studies for metabolite 2 showed that it did not inhibit activities of CYP2C19, 2D6, and 3A4.
Known hypersensitivity to crisaborole or any component of the formulation
Pregnancy: There is no available data with Crisaborole in pregnant women to inform the drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, there were no adverse developmental effects observed with oral administration of crisaborole in pregnant rats and rabbits during organogenesis at doses up to 3 and 2 times, respectively, the maximum recommended human dose (MRHD).
Lactation: There is no information available on the presence of crisaborole in human milk. Crisaborole is systemically absorbed. The lack of clinical data during lactation precludes a clear determination of the risk of crisaborole to a breastfed infant.
Do not store above 30°C temperature. Keep away from light and out of the reach of children.
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