EUCRISA Highlights

(crisaborole)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use EUCRISA safely and effectively. See full prescribing information for EUCRISA.

EUCRISA (crisaborole) ointment, for topical use
Initial U.S. Approval: 2016

INDICATIONS AND USAGE

EUCRISA is a phosphodiesterase 4 inhibitor indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 3 months of age and older. (1)

DOSAGE AND ADMINISTRATION

•
Apply a thin layer twice daily to affected areas. (2)
•
Once clinical effect is achieved, consider reducing application to once daily. (2)
•
For topical use only. (2)
•
Not for ophthalmic, oral, or intravaginal use. (2)

DOSAGE FORMS AND STRENGTHS

Ointment, 2%. (3)

CONTRAINDICATIONS

Known hypersensitivity to crisaborole or any component of the formulation. (4)

WARNINGS AND PRECAUTIONS

Hypersensitivity reactions: If signs and symptoms of hypersensitivity occur, discontinue EUCRISA immediately and initiate appropriate therapy. (5.1)

ADVERSE REACTIONS

The most common adverse reaction occurring in ≥1% in subjects is application site pain. (6.1)


To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 4/2023

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use EUCRISA safely and effectively. See full prescribing information for EUCRISA.

EUCRISA (crisaborole) ointment, for topical use
Initial U.S. Approval: 2016

INDICATIONS AND USAGE

EUCRISA is a phosphodiesterase 4 inhibitor indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 3 months of age and older. (1)

DOSAGE AND ADMINISTRATION

•
Apply a thin layer twice daily to affected areas. (2)
•
Once clinical effect is achieved, consider reducing application to once daily. (2)
•
For topical use only. (2)
•
Not for ophthalmic, oral, or intravaginal use. (2)

DOSAGE FORMS AND STRENGTHS

Ointment, 2%. (3)

CONTRAINDICATIONS

Known hypersensitivity to crisaborole or any component of the formulation. (4)

WARNINGS AND PRECAUTIONS

Hypersensitivity reactions: If signs and symptoms of hypersensitivity occur, discontinue EUCRISA immediately and initiate appropriate therapy. (5.1)

ADVERSE REACTIONS

The most common adverse reaction occurring in ≥1% in subjects is application site pain. (6.1)


To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 4/2023
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