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Roflumilast cream 0.3% and 0.15%

Brand and Other Names: ZORYVE
Mechanism of Action:

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.

Indications:

ZORYVE cream is a phosphodiesterase 4 inhibitor:

  • ZORYVE cream, 0.3%, is indicated for the topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 years of age and older. 
  • ZORYVE cream, 0.15%, is indicated for the topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older.
Route: Topical
Dose:
  • Apply ZORYVE cream:
    • 0.3%, once daily to affected areas of plaque psoriasis.
    • 0.15%, once daily to affected areas of mild to moderate atopic dermatitis.
  • For topical use only.
  • Not for ophthalmic, oral, or intravaginal use.
Adverse Reactions:

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

  • Plaque Psoriasis: diarrhea, headache, insomnia, nausea, application site pain, upper respiratory tract infections, and urinary tract infections. 
  • Atopic Dermatitis: headache, nausea, application site pain, diarrhea, and vomiting.
Contraindication:

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

Warnings and Precautions:

N/A

See package insert for full prescribing information.