(crisaborole)

Prescribing Information
Download Prescribing Information

13 NONCLINICAL TOXICOLOGY

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 300 mg/kg/day crisaborole were administered to rats once daily. A crisaborole-related increased incidence of benign granular cell tumors in the uterus with cervix and vagina (combined) was noted in 300 mg/kg/day crisaborole treated female rats (2 times the MRHD on an AUC comparison basis). The clinical relevance of this finding is unknown.

In a dermal carcinogenicity study in CD-1 mice, topical doses of 2%, 5%, or 7% crisaborole ointment were administered once daily. No crisaborole-related neoplastic findings were noted at topical doses up to 7% crisaborole ointment (1 times the MRHD on an AUC comparison basis).

Crisaborole revealed no evidence of mutagenic or clastogenic potential based on the results of two in vitro genotoxicity tests (Ames assay and human lymphocyte chromosomal aberration assay) and one in vivo genotoxicity test (rat micronucleus assay).

No effects on fertility were observed in male or female rats that were administered oral doses up to 600 mg/kg/day crisaborole (13 times the MRHD on an AUC comparison basis) prior to and during early pregnancy.

Medication Guide

MEDICATION GUIDE

This Patient Information has been approved by the U.S. Food and Drug Administration.

Revised: 4/2023

PATIENT INFORMATION
EUCRISA® (you-KRIS-a)
(crisaborole) ointment

Important information: EUCRISA is for use on skin (topical use) only. Do not use EUCRISA in your eyes, mouth, or vagina.

What is EUCRISA?

EUCRISA is a prescription medicine used on the skin (topical) to treat mild to moderate eczema (atopic dermatitis) in adults and children 3 months of age and older.

It is not known if EUCRISA is safe and effective in children under 3 months of age.

Who should not use EUCRISA?

Do not use EUCRISA if you are allergic to crisaborole or any of the ingredients in EUCRISA. See the end of this Patient Information leaflet for a complete list of ingredients in EUCRISA.

Before using EUCRISA, tell your healthcare provider about all of your medical conditions, including if you:

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are pregnant or plan to become pregnant. It is not known if EUCRISA will harm your unborn baby.
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are breastfeeding or plan to breastfeed. It is not known if EUCRISA passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use EUCRISA?

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Use EUCRISA exactly as your healthcare provider tells you to use it.
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Apply a thin layer of EUCRISA to the affected areas 2 times each day or as directed by your healthcare provider.
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Wash your hands after applying EUCRISA, unless hands are being treated. If someone else applies EUCRISA for you, they should wash their hands after applying EUCRISA.

What are the possible side effects of EUCRISA?

EUCRISA may cause side effects.

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Allergic reactions. EUCRISA may cause allergic reactions at or near the application site or at a distant site which may be serious. Stop using EUCRISA and get medical help right away if you have any symptoms of an allergic reaction including:
o
trouble breathing or throat tightness
o
hives
o
chest tightness
o
itching
o
feeling faint
o
swelling of your face, eyelids, lips, mouth, tongue or throat
o
redness

The most common side effect of EUCRISA is application site pain, such as burning or stinging.

This is not the only possible side effect of EUCRISA.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store EUCRISA?

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Store EUCRISA at room temperature, between 68°F to 77°F (20°C to 25°C).
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Keep the tube tightly closed.

Keep EUCRISA and all medicines out of the reach of children.

General information about the safe and effective use of EUCRISA

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use EUCRISA for a condition for which it was not prescribed. Do not give EUCRISA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about EUCRISA that is written for healthcare professionals.

What are the ingredients in EUCRISA?

Active ingredient: crisaborole

Inactive ingredients: white petrolatum, propylene glycol, mono- and di-glycerides, paraffin, butylated hydroxytoluene, and edetate calcium disodium.

eucrisa-06

LAB-0917-5.0

For more information, call 1-866-EUCRISA [1-866-382-7472] or go to www.EUCRISA.com

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