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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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Pfizer Safety

To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at
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FDA Medwatch
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.