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.
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.
Hypersensitivity reactions, including contact urticaria have occurred in patients treated with Crisaborole. If signs and symptoms of hypersensitivity occur, discontinue Crisaborole immediately and initiate appropriate therapy.
Topical anti-inflammatory preparations
Do not store above 30°C temperature. Keep away from light and out of the reach of children.
