(crisaborole)
6 ADVERSE REACTIONS
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In two double-blind, vehicle-controlled clinical trials (Trial 1 and Trial 2), 1012 subjects 2 to 79 years of age with mild to moderate atopic dermatitis were treated with EUCRISA twice daily for 4 weeks. The adverse reaction reported by ≥1% of EUCRISA-treated subjects is listed in Table 1.
| Adverse Reaction | EUCRISA Twice Daily N=1012 n (%) | Vehicle Twice Daily N=499 n (%) |
|---|---|---|
| ||
Application site pain* | 45 (4) | 6 (1) |
Less common (<1%) adverse reactions in subjects treated with EUCRISA included contact urticaria [see Warnings and Precautions (5.1)].
In one double-blind, vehicle-controlled trial including an initial open-label period (Trial 3), 497 subjects 3 months of age and older with mild to moderate atopic dermatitis received EUCRISA twice daily for up to 8 weeks. This was followed by a double-blind period, during which 135 subjects out of 270 randomized subjects received EUCRISA and 135 subjects received vehicle once daily for 52 weeks or until they developed a flare. The adverse reactions observed in the open-label period were similar to the known safety profile of twice daily treatment with EUCRISA. The adverse reactions observed with once daily treatment were similar to vehicle [see Clinical Studies (14)].
6.2 Postmarketing Experience
The following adverse reactions have been identified during postapproval use of EUCRISA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:
Skin and Subcutaneous: allergic contact dermatitis
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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