Eucrisa

Eucrisa (crisaborole) is a non-steroidal ointment used for the treatment of eczema (atopic dermatitis) to improve itching, redness, oozing, and crusting. Eucrisa provides long-term symptom relief without the side effects associated with corticosteroids.

Eucrisa works by inhibiting the PDE-4 enzyme, an enzyme involved in inflammation. In patients with eczema, PDE-4 enzymes are overactive, leading to increased skin inflammation and irritation. By blocking PDE-4 activity, Eucrisa helps improve eczema symptoms, including redness, swelling, and itching.

Eucrisa's mechanism of action (MOA) is a non-steroidal phosphodiesterase-4 (PDE-4) inhibitor.

Eucrisa's FDA approval is to treat mild to moderate atopic dermatitis (eczema) in patients 3 months and older. There is no Eucrisa generic available.

In the phase 3 clinical trial AD-302, patients aged 2 years and older were treated with Eucrisa 2% ointment twice daily for 28 days. Results showed:

• 32% of Eucrisa patients achieved clear or almost clear skin at day 28, compared to 18% in the placebo group.*
• A significant reduction in itching was observed as early as day 8.

Eucrisa used in infants aged 3 months to less than 2 years in the Phase IV Open-Label Study called CrisADe CARE 1 (NCT03356977) resulted in:

• 30.2% of infant patients achieved clear or almost clear skin at day 29.*

*Eczema was measured using ISGA (Investigator’s Static Global Assessment).

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

You should not use Eucrisa ointment if you are allergic to crisaborole.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breastfeed while using Eucrisa. Ask your doctor about any risk.

Eucrisa is not approved for use by anyone younger than 3 months old.

The most common Eucrisa side effects include:

• pain, burning, or stinging where the medicine was applied in 4% of patients (compared to 1% in the placebo group)

These Eucrisa ointment side effects occurred in the clinical trials AD-301 (NCT02118766) and AD-302 (NCT02118792).

Serious side effects may occur. Get emergency medical help if you have signs of an allergic reaction to Eucrisa: hives, itching, skin redness or swelling, difficulty breathing, and swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

• Severe itching, redness, or swelling of the skin where the medicine was applied.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• Apply a thin layer of Eucrisa to the affected area twice daily.
• Wash hands after applying (unless treating hands).
• Do not apply to eyes, mouth, or vagina.

• You should use it for as long as your doctor has told you to use it.
• The clinical trial (AD-303) studied the safety of using Eucrisa for 48 weeks in patients over 2 years of age had a favorable safety profile.

Eucrisa ointment used on the skin is not likely to be affected by other drugs you use. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

You may pay as little as $10 out-of-pocket if you qualify for the Eucrisa copay card (coupon). The Eucrisa Coupon or Copay Card helps you save money on prescriptions if you have commercial or private insurance and fit the criteria.

For more information about the Eucrisa coupon and prices see our Eucrisa Prices, Coupons, Copay Cards & Patient Assistance page.

• Store at room temperature (20°C to 25°C / 68°F to 77°F).
• Keep the tube tightly closed and away from heat or moisture.
• Keep out of reach of children.

Active ingredient: crisaborole

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

Eucrisa manufacturer Pfizer Labs, Division of Pfizer Inc. New Your, NY 10001

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