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Crisaborole (Topical) (Monograph)

Brand name: Eucrisa
Drug class: Phosphodiesterase-4 Inhibitors

Medically reviewed by Drugs.com on May 10, 2024. Written by ASHP.

Introduction

Anti-inflammatory agent; selective phosphodiesterase type 4 (PDE4) inhibitor.

Uses for Crisaborole (Topical)

Atopic Dermatitis

Topical treatment of mild to moderate atopic dermatitis (eczema) in adults and children ≥2 years of age.

Crisaborole (Topical) Dosage and Administration

Administration

Topical Administration

Apply topically as a 2% ointment.

For external use only. Do not administer orally, vaginally, or topically to the eye.

Apply evenly as a thin layer to affected areas of skin.

Wash hands after applying, unless hands are being treated.

Dosage

Pediatric Patients

Atopic Dermatitis
Topical

Children ≥2 years of age: Apply thin layer of 2% ointment to affected areas of skin twice daily.

Adults

Atopic Dermatitis
Topical

Apply thin layer of 2% ointment to affected areas of skin twice daily.

Special Populations

No special population dosage recommendations.

Cautions for Crisaborole (Topical)

Contraindications

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity Reactions

Hypersensitivity reactions (e.g., urticaria) reported.

Suspect hypersensitivity if severe pruritus, swelling, and erythema occur at site of application or at distant site.

If signs and symptoms of hypersensitivity occur, discontinue immediately and initiate appropriate treatment.

Specific Populations

Pregnancy

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

Adverse embryofetal effects not observed in animal studies using oral crisaborole.

Lactation

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

Consider benefits of breast-feeding and importance of the drug to the woman; also consider potential adverse effects on the breast-fed infant from the drug or underlying maternal condition.

Pediatric Use

Safety and efficacy not established in children <2 years of age.

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.

Common Adverse Effects

Application site pain (burning, stinging).

Drug Interactions

Does not inhibit CYP isoenzyme 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, or 3A4; not expected to induce CYP isoenzymes.

Specific Drugs

Drug

Interaction

Warfarin

Drug interactions not expected

Crisaborole (Topical) Pharmacokinetics

Absorption

Bioavailability

Rapidly absorbed systemically following topical application to the skin.

Following topical application of crisaborole 2% ointment (approximately 3 mg/cm2) twice daily for 8 days in pediatric patients 2–17 years of age with atopic dermatitis, plasma concentrations of the drug were detectable in all patients. Mean peak plasma concentration was 127 ng/mL; steady-state plasma concentrations were attained by day 8.

Onset

Reduction of pruritus occurs as early as 8 days after initiation of topical crisaborole.

Distribution

Extent

Not known whether systemically absorbed crisaborole is distributed into human milk.

Plasma Protein Binding

97%.

Elimination

Metabolism

Systemically absorbed drug is rapidly and extensively metabolized to inactive metabolites.

Elimination Route

Systemically absorbed drug excreted principally in urine as inactive metabolites.

Stability

Storage

Topical

Ointment

20–25°C (may be exposed to 15–30°C).

Actions

Advice to Patients

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Crisaborole

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Topical

Ointment

2%

Eucrisa

Anacor

AHFS DI Essentials™. © Copyright 2024, Selected Revisions May 10, 2024. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

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