Version May 2024
Plaque psoriasis: Children ≥6 years and Adolescents: 0.3% cream: Topical: Apply to affected area(s) once daily.
There are no dosage adjustments provided in the manufacturer's labeling.
Children ≥6 years and Adolescents:
Mild impairment: There are no dosage adjustments provided in the manufacturer's labeling.
Moderate or severe impairment: Use is contraindicated.
(For additional information see "Roflumilast (topical): Drug information")
Plaque psoriasis: Topical: Cream: Apply once daily to affected areas.
Seborrheic dermatitis: Topical: Foam: Apply once daily to affected areas.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Child-Turcotte-Pugh class A: No dosage adjustment needed.
Child-Turcotte-Pugh class B and C: Use is contraindicated.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in children, adolescents, and adults.
1% to 10%:
Gastrointestinal: Diarrhea (≤3%), nausea (1%)
Genitourinary: Urinary tract infection (1%)
Local: Application-site pain (1%)
Nervous system: Headache (1% to 2%), insomnia (≤1%)
Respiratory: Nasopharyngitis (2%), upper respiratory tract infection (1%)
Moderate to severe liver impairment (Child-Turcotte-Pugh class B or C).
Canadian labeling: Additional contraindications (not in the US labeling): Hypersensitivity to roflumilast or any component of the formulation.
Dosage form specific:
• Foam: Foam contains flammable propellants. Avoid fire, flame, and smoking during and immediately following administration.
Other warnings/precautions:
• Appropriate use: For topical use only; not for ophthalmic, oral, or intravaginal use.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, External:
Zoryve: 0.3% (60 g) [contains cetostearyl alcohol, methylparaben, propylparaben]
Foam, External:
Zoryve: 0.3% (60 g) [contains cetyl alcohol, methylparaben, propylparaben]
No
Cream (Zoryve External)
0.3% (per gram): $17.16
Foam (Zoryve External)
0.3% (per gram): $17.16
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, External:
Zoryve: 0.3% (5 g, 60 g) [contains cetostearyl alcohol, methylparaben, propylparaben]
Topical: For topical use only; not for ophthalmic, oral, or intravaginal use. Rub cream in completely to affected area(s). Wash hands following application unless using for treatment of psoriasis on hands.
Topical: For topical use only; not for ophthalmic, oral, or intravaginal use. Wash hands after use, unless treating the hands.
Cream: Rub in completely.
Foam: Shake well prior to use. Apply a thin layer to dry skin and/or scalp; rub in completely. Avoid fire, flame, and smoking during and immediately following use.
Cream: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F).
Foam: Store upright at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). Contents are under pressure; do not puncture or incinerate; do not expose to heat or store at temperatures above 49°C (120°F). Do not freeze.
Topical treatment of plaque psoriasis, including intertriginous areas (FDA approved in ages ≥6 years and adults).
Substrate of CYP1A2 (minor), CYP3A4 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Cimetidine: May increase serum concentrations of the active metabolite(s) of Roflumilast-Containing Products. Cimetidine may increase the serum concentration of Roflumilast-Containing Products. Risk C: Monitor therapy
Ciprofloxacin (Systemic): May increase the serum concentration of Roflumilast-Containing Products. Risk C: Monitor therapy
Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy
CYP3A4 Inhibitors (Moderate): May increase the serum concentration of Roflumilast-Containing Products. Risk C: Monitor therapy
CYP3A4 Inhibitors (Strong): May increase the serum concentration of Roflumilast-Containing Products. Risk C: Monitor therapy
Enoxacin: May increase the serum concentration of Roflumilast-Containing Products. Risk C: Monitor therapy
Ethinyl Estradiol-Containing Products: May increase serum concentrations of the active metabolite(s) of Roflumilast-Containing Products. Ethinyl Estradiol-Containing Products may increase the serum concentration of Roflumilast-Containing Products. Risk C: Monitor therapy
Fexinidazole: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination
FluvoxaMINE: May increase serum concentrations of the active metabolite(s) of Roflumilast-Containing Products. FluvoxaMINE may increase the serum concentration of Roflumilast-Containing Products. Risk C: Monitor therapy
Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination
Riociguat: Roflumilast-Containing Products may enhance the hypotensive effect of Riociguat. Risk C: Monitor therapy
Tobacco (Smoked): May decrease the serum concentration of Roflumilast-Containing Products. Risk C: Monitor therapy
Viloxazine: May increase serum concentrations of the active metabolite(s) of Roflumilast-Containing Products. Viloxazine may increase the serum concentration of Roflumilast-Containing Products. Risk C: Monitor therapy
Animal reproduction studies have not been conducted with topical roflumilast.
Monitor for application-site pain.
Roflumilast and its active N-oxide metabolite selectively inhibit phosphodiesterase-4 (PDE4), leading to accumulation of cyclic AMP (cAMP). The specific mechanism(s) by which roflumilast exerts its therapeutic action is not well defined.
Protein binding: ~99%; N-oxide metabolite: 97%.
Metabolism: Hepatic via CYP3A4 and CYP1A2 to active N-oxide metabolite; also undergoes conjugation.
Half-life elimination: 3.6 to 4 days; N-oxide metabolite: 4.4 to 4.6 days.
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