Eucrisa (crisaborole)

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Crisaborole is applied topically to the skin as a 2% ointment.

Crisaborole ointment is for external use only and should not be used orally, ophthalmically, or vaginally; contact with the eyes should be avoided.

A thin layer of crisaborole ointment should be applied to affected areas of skin.

Hands should be washed after applying the ointment, unless the hands are being treated.

Keep the tube of ointment tightly closed when not in use. Store at 20-25oC.

No dosing information is available for this tab.

In vitro studies indicate that crisaborole and its initial metabolite are not expected to inhibit cytochrome P-450 (CYP) isoenzymes 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, or 3A4. In vitro studies also indicate that the subsequent metabolite does not inhibit CYP2C19, 2D6, or 3A4, but is a weak inhibitor of CYP1A2 and 2B6 and a moderate inhibitor of CYP2C8 and 2C9. Crisaborole and its metabolites are not expected to induce CYP isoenzymes.

In vitro studies indicate that crisaborole and its initial metabolite do not inhibit uridine disphosphate (UDP)-glucuronosyltransferase (UGT) isoenzymes 1A1, 1A4, 1A6, 1A9, 2B7, or 2B15. In vitro studies also indicate that the subsequent metabolite does not inhibit UGT1A4, 1A6, 2B7, or 2B15, but is a weak inhibitor of UGT1A1 and a moderate inhibitor of UGT1A9.

In vitro studies indicate that crisaborole and its metabolites are not expected to have clinically significant interactions with P-glycoprotein substrates and organic anionic or cationic transporters. In vitro studies also indicate that crisaborole and its initial metabolite are not expected to inhibit breast cancer resistance protein (BCRP), but its subsequent metabolite is expected to inhibit BCRP at therapeutic concentrations.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Known hypersensitivity to crisaborole or any ingredient in the formulation.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

• No disease contraindications

Adverse effects occurring in >=1% of patients receiving topical crisaborole for the treatment of atopic dermatitis include application site pain (burning or stinging).

Rare or Very Rare

• Hypersensitivity drug reaction
• Urticaria

More Frequent

• Acute pain at drug application site

Rare or Very Rare

• Contact dermatitis

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Safety and efficacy of topical crisaborole have not been established in pediatric patients younger than 3 months of age.

Safety and efficacy of crisaborole for the topical treatment of mild to moderate atopic dermatitis in pediatric patients 3 months of age and older is supported by evidence from 2 multicenter, randomized, double-blind, parallel-group, vehicle-controlled trials that included 1313 pediatric patients 2-17 years of age, a safety and pharmacokinetics trial that included 137 pediatric patients 3 months to <2 years of age, and another clinical trial with an open-label period of up to 8 weeks that included 327 pediatric patients 5 months to <18 years of age.

Data are inadequate regarding the use of topical crisaborole in pregnant women.

Animal reproduction studies with oral crisaborole have not revealed evidence of fetal harm at exposures greater than those attained with the maximum recommended human topical dosage.

It is not known whether systemically absorbed crisaborole is distributed into human milk, affects human milk production, or affects breast-fed infants.

The benefits of breast-feeding and the importance of topical crisaborole to the woman should be considered along with potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition.

The manufacturer makes no specific dosage recommendations for geriatric patients.

Clinical studies of topical crisaborole did not include sufficient numbers of patients 65 years of age and older to determine whether geriatric patients respond differently than younger patients.