Generic Name: crisaborole
Dosage Form: Ointment
Date of Approval: December 15, 2016
Company: Pfizer, Inc.
Treatment for: Atopic Dermatitis
FDA Approves Eucrisa
The U.S. Food and Drug Administration (FDA) has approved Eucrisa (crisaborole) ointment 2%, a novel, non-steroidal topical phosphodieterase-4 (PDE-4) inhibitor for the treatment of mild to moderate atopic dermatitis (eczema) in patients two years of age and older.
Important information: Eucrisa is for use on skin (topical use) only. Do not use this ointment 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 2 years of age and older.
It is not known if Eucrisa is safe and effective in children under 2 years of age.
Who should not use Eucrisa?
Do not use Eucrisa if you are allergic to crisaborole or any of the other ingredients. See the end of this leaflet for a complete list of ingredients contained in the ointment.
Before you start treatment, tell your healthcare provider about all of your medical conditions, including if you:
- are pregnant or plan to become pregnant. It is not known if the active ingredient will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if the active ingredient 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?
- Use Eucrisa exactly as your healthcare provider tells you to use it.
- Apply a thin layer of ointment to the affected areas two times each day.
- Wash your hands after applying the ointment, unless hands are being treated. If someone else applies the ointment for you, they should wash their hands after after application.
Eucrisa side effects
Side effects can include:
- Allergic reactions. Eucrisa may cause allergic reactions at or near the application site. These can be serious and may include hives, itching, swelling, and redness. If you have any of these symptoms, stop treatment and get medical help right away.
The most common side effect is application site pain, such as burning or stinging.
This is not the only possible side effect. 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?
- Store the ointment at room temperature, between 68°F and 77°F (20°C and 25°C).
- Keep the tube tightly closed.
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 this medicine for a condition for which it was not prescribed. Do not give it 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 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.