Dosing & Uses
Dosage Forms & Strengths
topical ointment
- 2%
Atopic Dermatitis
Indicated for mild-to-moderate atopic dermatitis
Apply a thin layer topically to affected area(s) BID
Once clinical effect achieved, consider reducing application to once daily
Dosage Forms & Strengths
topical ointment
- 2%
Atopic Dermatitis
Indicated for mild to moderate atopic dermatitis in infants and children aged ≥3 months
<3 months: Safety and efficacy not established
≥3 months
- Apply a thin layer topically to affected area(s) BID
- Once clinical effect achieved, consider reducing application to once daily
Adverse Effects
1-10%
Application site pain, burning, or stinging (4%)
<1%
Contact urticaria
Postmarketing Reports
Allergic contact dermatitis
Warnings
Contraindications
History of hypersensitivity to crisaborole or any component of the formulation
Cautions
Hypersensitivity reactions reported, including contact urticaria; signs and symptoms may include severe pruritus, swelling, and erythema at the application site or at a distant site; discontinue immediately and initiate appropriate therapy if hypersensitivity suspected (see Contraindications)
Pregnancy
Pregnancy
Available data from case reports with use in pregnant women are insufficient to inform a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes
Crisaborole is systemically absorbed
Animal studies
- No adverse developmental effects observed in animal reproduction studies, with oral administration of this drug in pregnant rats and rabbits during organogenesis at doses up to 3 and 2 times, respectively, the maximum recommended human dose (MRHD)
Lactation
Unknown if distributed in human breast milk
Crisaborole is systemically absorbed
Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Phosphodiesterase (PDE)-4 inhibitor; results in increased intracellular cyclic adenosine monophosphate (cAMP) levels
The specific mechanism by which crisaborole exerts its therapeutic action for atopic dermatitis is not well defined, although cAMP is thought to decrease the proinflammatory response (eg, cytokine release) associated with atopic dermatitis
Absorption
Steady-state reached on Day 8
Peak plasma concentration: 188 ng/mL
AUC: 1164 ng⋅hr/mL
Distribution
Protein bound: 97%
Metabolism
Substantially metabolized into inactive metabolites
Major metabolites: 5-(4-cyanophenoxy)-2-hydroxyl benzyl alcohol (metabolite 1) is formed via hydrolysis; it is further metabolized into downstream metabolites, among which 5-(4-cyanophenoxy)-2-hydroxyl benzoic acid (metabolite 2), formed via oxidation, is also a major metabolite
Elimination
Excretion: Renal excretion of metabolites is the major route of elimination
Administration
Topical Administration
Apply thin layer of ointment to affected areas BID
Wash hands after applying ointment, unless hands are being treated
For topical use only; not for ophthalmic, oral, or intravaginal use
Storage
Store at controlled room temperature 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)
Images
BRAND | FORM. | UNIT PRICE | PILL IMAGE |
---|---|---|---|
Eucrisa topical - | 2 % ointment | ![]() |
Copyright © 2010 First DataBank, Inc.
Formulary
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