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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

RECENT MAJOR CHANGES

Indications and Usage (1)03/2020

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)
  • 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: 4/2020

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Report Adverse Event

Contact Pfizer Safety to report an adverse event, side effect or concern about the quality of a Pfizer product: (800) 438-1985

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns at 1-800-FDA-1088 or www.fda.gov/MedWatch