(crisaborole)
8 USE IN SPECIFIC POPULATIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Available data from case reports with EUCRISA use in pregnant women are insufficient to inform a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, there were no adverse developmental effects observed with oral administration of crisaborole in pregnant rats and rabbits during organogenesis at doses up to 3 and 2 times, respectively, the maximum recommended human dose (MRHD) (see Data).
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies carry some risk of birth defect, loss, or other adverse outcomes. The background risk of major birth defects in the U.S. general population is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies.
Animal Data
Rat and rabbit embryo-fetal development was assessed after oral administration of crisaborole. Crisaborole did not cause adverse effects to the fetus at oral doses up to 300 mg/kg/day in pregnant rats during the period of organogenesis (3 times the MRHD on an area under the curve (AUC) comparison basis). No crisaborole-related fetal malformations were noted after oral treatment with crisaborole in pregnant rats at doses up to 600 mg/kg/day (13 times the MRHD on an AUC comparison basis) during the period of organogenesis. Maternal toxicity was produced at this high dose of 600 mg/kg/day in pregnant rats and was associated with decreased fetal body weight and delayed skeletal ossification. Crisaborole did not cause adverse effects to the fetus at oral doses up to the highest dose tested of 100 mg/kg/day in pregnant rabbits during the period of organogenesis (2 times the MRHD on an AUC comparison basis).
In a prenatal/postnatal development study, pregnant rats were treated with crisaborole at doses of 150, 300, or 600 mg/kg/day by oral gavage during gestation and lactation (from gestation day 7 through day 20 of lactation). Crisaborole did not have any adverse effects on fetal development at doses up to 300 mg/kg/day (3 times the MRHD on an AUC comparison basis). Maternal toxicity was produced at the high dose of 600 mg/kg/day in pregnant rats and was associated with stillbirths, pup mortality, and reduced pup weights.
8.2 Lactation
Risk Summary
There is no information available on the presence of EUCRISA in human milk, the effects of the drug on the breastfed infant or the effects of the drug on milk production after topical application of EUCRISA to women who are breastfeeding. EUCRISA is systemically absorbed. The lack of clinical data during lactation precludes a clear determination of the risk of EUCRISA to a breastfed infant. Therefore, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for EUCRISA and any potential adverse effects on the breastfed infant from EUCRISA or from the underlying maternal condition.
8.4 Pediatric Use
The safety and effectiveness of EUCRISA have been established in pediatric patients ages 3 months and older for topical treatment of mild to moderate atopic dermatitis. Use of EUCRISA administered twice daily in this age group is supported by data from two 28-day adequate, vehicle-controlled safety and efficacy trials (1,313 pediatric subjects ages 2 years to 17 years of whom 874 received EUCRISA), a 28-day open-label, safety and pharmacokinetics (PK) trial (137 subjects ages 3 months to less than 2 years who received EUCRISA), and another trial with an open-label period of up to 8 weeks (327 pediatric subjects ages 5 months to less than 18 years who received EUCRISA) [see Clinical Pharmacology (12.3) and Clinical Studies (14)].
The safety and effectiveness of EUCRISA in pediatric patients below the age of 3 months have not been established.
MEDICATION GUIDE
This Patient Information has been approved by the U.S. Food and Drug Administration. | Revised: 4/2023 | |
PATIENT INFORMATION | ||
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:
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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What are the possible side effects of EUCRISA? EUCRISA may cause side effects.
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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?
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.  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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