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EUCRISA (crisaborole)

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EUCRISA Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

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1 INDICATIONS AND USAGE

EUCRISA is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 3 months of age and older....

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2 DOSAGE AND ADMINISTRATION

Apply a thin layer of EUCRISA twice daily to affected areas.

EUCRISA is for topical use only and not for ophthalmic, oral, or intravaginal use.

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3 DOSAGE FORMS AND STRENGTHS

Ointment: 20 mg of crisaborole per gram (2%) of white to off-white ointment.

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4 CONTRAINDICATIONS

EUCRISA is contraindicated in patients with known hypersensitivity to crisaborole or any component of the formulation. [see Warnings and Precautions (5. 1)]...

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5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity Reactions

Hypersensitivity reactions, including contact urticaria, have occurred in patients treated with EUCRISA....

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6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

There is no available...

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11 DESCRIPTION

EUCRISA contains 2% crisaborole (w/w) in a petrolatum-based, white to off-white ointment and is for topical use. The active ingredient, crisaborole, is a phosphodiesterase-4 (PDE-4) inhibitor.

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Crisaborole is a phosphodiesterase 4 (PDE-4) inhibitor. PDE-4 inhibition results in increased intracellular cyclic...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

In an oral carcinogenicity study in Sprague-Dawley rats, oral doses of 30, 100, or...

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14 CLINICAL STUDIES

Two multicenter, randomized, double-blind, parallel-group, vehicle-controlled trials (Trials 1 and 2) treated a total of 1522 subjects 2 to 79 years of age (86.3% of subjects were 2 to 17 years of age)...

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16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

EUCRISA is a white to off-white ointment containing 2% crisaborole and is supplied in 60 g and 100 g laminate...

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17 PATIENT COUNSELING INFORMATION

Advise the patient or caregivers to read the FDA-approved patient labeling (Patient Information).

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This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

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Resources

EUCRISA Co-Pay Savings Card
For questions regarding the EUCRISA Co-Pay Savings Card, please call (877) 548-1739
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