Roflumilast and its active metabolite (roflumilast N-oxide) are inhibitors of PDE4. Roflumilast and roflumilast N-oxide inhibition of PDE4 (a major cyclic 3′,5′-adenosine monophosphate (cyclic AMP) metabolizing enzyme) activity leads to accumulation of intracellular cyclic AMP. The specific mechanism(s) by which roflumilast exerts its therapeutic action is not well defined.

ZORYVE topical foam, 0.3%, is a phosphodiesterase 4 inhibitor indicated for the treatment of

• seborrheic dermatitis in adult and pediatric patients 9 years of age and older.
• plaque psoriasis of the scalp and body in adult and pediatric patients 12 years of age and older. 

• Apply once daily to affected areas.
• For topical use only. Not for ophthalmic, oral, or intravaginal use.

The most common adverse reactions (reported in ≥ 1% of patients) are:

• Seborrheic dermatitis: nasopharyngitis, nausea, and headache.
• Plaque psoriasis of the scalp and body: headache, diarrhea, nausea, and nasopharyngitis.

To report SUSPECTED ADVERSE REACTIONS, contact Arcutis Biotherapeutics, Inc. at 1-844-692-6729 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Moderate to severe liver impairment (Child-Pugh B or C).

Flammability: The propellants in ZORYVE foam, 0.3%, are flammable. Avoid fire, flame, and smoking during and immediately following application.