Zoryve Foam
(Roflumilast)Dosage & Administration
Shake can prior to each use. Apply a thin layer of ZORYVE foam, 0.3%, once daily to affected areas of body and/or scalp when they are not wet. Rub in completely.
Wash hands after application.
Avoid fire, flame, and smoking during and immediately following application
The propellants in ZORYVE foam, 0.3%, are flammable. Avoid fire, flame, and smoking during and immediately following application.
ZORYVE foam, 0.3%, is for topical use only and not for ophthalmic, oral, or intravaginal use.
By using PrescriberAI, you agree to the AI Terms of Use.
Zoryve Foam Prescribing Information
Indications and Usage, Plaque Psoriasis (ZORYVE topical foam, 0.3%, is indicated for the treatment of plaque psoriasis of the scalp and body in adult and pediatric patients 12 years of age and older. | 5/2025 |
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. ()
1.1 Seborrheic DermatitisZORYVE®topical foam, 0.3%, is 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. ()
1.2 Plaque PsoriasisZORYVE topical foam, 0.3%, is indicated for the treatment of plaque psoriasis of the scalp and body in adult and pediatric patients 12 years of age and older.
Shake can prior to each use. Apply a thin layer of ZORYVE foam, 0.3%, once daily to affected areas of body and/or scalp when they are not wet. Rub in completely.
Wash hands after application.
Avoid fire, flame, and smoking during and immediately following application
The propellants in ZORYVE foam, 0.3%, are flammable. Avoid fire, flame, and smoking during and immediately following application.
ZORYVE foam, 0.3%, is for topical use only and not for ophthalmic, oral, or intravaginal use.
Topical foam, 0.3%: 3 mg of roflumilast per gram of white to off-white foam in 60-gram pressurized cans.
There are insufficient data available on the use of ZORYVE foam, 0.3%, in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, roflumilast administered orally to pregnant rats and rabbits during the period of organogenesis produced no fetal structural abnormalities at doses up to 21 and 18 times the maximum recommended human dose (MRHD), respectively. Roflumilast induced post-implantation loss in rats at oral doses greater than or equal to 7 times the MRHD. Roflumilast induced stillbirth and decreased pup viability in mice at oral doses 11 and 34 times the MRHD, respectively. Roflumilast has been shown to adversely affect pup post-natal development when dams were treated with an oral dose 34 times the MRHD during pregnancy and lactation periods in mice
In an embryo-fetal development study, pregnant rats were dosed orally during the period of organogenesis with up to 1.8 mg/kg/day roflumilast (21 times the MRHD on a mg/m2basis). No evidence of structural abnormalities or effects on survival rates were observed. Roflumilast did not affect embryo-fetal development at a maternal oral dose of 0.2 mg/kg/day (2 times the MRHD on a mg/m2basis).
In a fertility and embryo-fetal development study, male rats were dosed orally with up to 1.8 mg/kg/day roflumilast for 10 weeks and females for 2 weeks prior to pairing and throughout the organogenesis period. Roflumilast induced pre- and post-implantation loss at maternal oral doses greater than or equal to 0.6 mg/kg/day (7 times the MRHD on a mg/m2basis). Roflumilast did not cause fetal structural abnormalities at maternal oral doses up to 1.8 mg/kg/day (20 times the MRHD on a mg/m2basis).
In an embryo-fetal development study in rabbits, pregnant does were dosed orally with 0.8 mg/kg/day roflumilast during the period of organogenesis. Roflumilast did not cause fetal structural abnormalities at the maternal oral doses of 0.8 mg/kg/day (18 times the MRHD on a mg/m2basis).
In pre- and post-natal developmental studies in mice, dams were dosed orally with up to 12 mg/kg/day roflumilast during the period of organogenesis and lactation. Roflumilast induced stillbirth and decreased pup viability at maternal oral doses greater than 2 mg/kg/day and 6 mg/kg/day, respectively (11 and 34 times the MRHD on a mg/m2basis, respectively). Roflumilast induced delivery retardation in pregnant mice at maternal oral doses greater than 2 mg/kg/day (11 times the MRHD on a mg/m2basis). Roflumilast decreased pup rearing frequencies at a maternal oral dose of 6 mg/kg/day during pregnancy and lactation (34 times the MRHD on a mg/m2basis). Roflumilast also decreased survival and forelimb grip reflex and delayed pinna detachment in mouse pups at a maternal oral dose of 12 mg/kg/day (68 times the MRHD on a mg/m2basis).
The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
ZORYVE foam, 0.3%, is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C)
Oral roflumilast 250 mcg once daily for 14 days was studied in subjects with hepatic impairment. The systemic exposure of roflumilast and roflumilast N-oxide were increased in subjects with moderate (Child-Pugh B) hepatic impairment. ZORYVE foam, 0.3%, is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C). No dosage adjustment is needed in patients with mild (Child-Pugh A) hepatic impairment
The pharmacokinetics of ZORYVE foam, 0.3%, was investigated in 10 adult and 10 pediatric (11 to 16 years of age) subjects with seborrheic dermatitis. In this study, a mean dose of approximately 4.1 g of ZORYVE foam, 0.3%, was applied once daily for 15 days to a mean ± SD body surface area (BSA) involvement of 6.5 ± 1.08% and 5.5 ± 1.27% in adult and pediatric subjects, respectively. Plasma concentrations of roflumilast were quantifiable in all but two subjects at Day 15. Plasma concentrations of roflumilast N-oxide were quantifiable in all subjects at Day 15. Following application of ZORYVE foam, 0.3%, the plasma concentration versus time profile was relatively flat, with mean peak-to-trough ratios of 1.68 and 1.62 for roflumilast and roflumilast N-oxide, respectively.
In adults, the mean ± SD maximum concentration (Cmax) was 2.2 ± 1.6 and 13.8 ± 9.0 ng/mL for roflumilast and the N-oxide metabolite, respectively. The mean ± SD systemic exposure (AUC0-24) was 36.6 ± 23.7 and 261 ± 190 h∙ng/mL for roflumilast and the N-oxide metabolite, respectively. In pediatric subjects, the extrapolated mean ± SD AUC0-24(based on pre-dose concentration) was 25.1 ± 30.2 and 253 ± 404 h∙ng/mL for roflumilast and the N-oxide metabolite, respectively.
The pharmacokinetics of ZORYVE foam, 0.3%, was investigated in 19 adults and 7 pediatric subjects 12 to 16 years of age with plaque psoriasis of the scalp and body. The entire scalp (BSA of approximately 4.5%) was treated in addition to the mean ± SD BSA involvement on the body of 25.0 ± 7.88% and 10.4 ± 0.54% in adults and pediatric subjects, respectively. In this study, the mean daily dose administered in adults was 10.3 g and in pediatric subjects from 12 to 16 years of age was 5.3 g of ZORYVE foam, 0.3%, once daily for 15 days. Following application of ZORYVE foam, 0.3%, the plasma concentration versus time profile was flat, with mean peak-to-trough ratios of approximately 1.2 for both roflumilast and roflumilast N-oxide.
In adults, the mean ± SD Cmaxwas 4.48 ± 2.28 and 29.9 ± 17.5 ng/mL for roflumilast and the N-oxide metabolite, respectively, on Day 15. The mean ± SD AUC0-24was 90 ± 58.7 and 567 ± 436 h∙ng/mL for roflumilast and the N-oxide metabolite, respectively, on Day 15. In pediatric subjects, the extrapolated mean ± SD AUC0-24(based on pre-dose concentration) was 35.5 ± 41.4 and 270 ± 293 h∙ng/mL for roflumilast and the N-oxide metabolite, respectively, on Day 15.
Plasma protein binding of roflumilast and its N-oxide metabolite is approximately 99% and 97%, respectively.
The plasma clearance after short-term intravenous infusion of roflumilast is on average about 9.6 L/h. Following topical administration, the mean half-lives of both roflumilast and the N-oxide metabolite were in the range of 3.6 to 5 days.
Roflumilast is extensively metabolized via Phase I (cytochrome P450) and Phase II (conjugation) reactions. The N-oxide metabolite is the only major metabolite observed in the plasma of humans. Following oral administration, roflumilast and roflumilast N-oxide account for the majority (87.5%) of total dose administered in plasma. Roflumilast was not detectable in urine, while roflumilast N-oxide was only a trace metabolite (less than 1%). Other conjugated metabolites such as roflumilast N-oxide glucuronide and 4-amino-3,5-dichloropyridine N-oxide were detected in urine.
While roflumilast is 3 times more potent than roflumilast N-oxide at inhibition of the PDE4 enzyme
Following topical administration, no clinically significant differences in the pharmacokinetics of roflumilast and roflumilast N-oxide were observed based on age, sex, race, or ethnicity.
No studies were conducted with topical roflumilast in subjects with hepatic impairment; however, oral roflumilast 250 mcg once daily for 14 days was studied in subjects with mild to moderate hepatic impairment classified as Child-Pugh A and B (8 subjects in each group). The AUC of roflumilast and roflumilast N-oxide were increased by 51% and 24%, respectively, in Child-Pugh A subjects and by 92% and 41%, respectively, in Child-Pugh B subjects, as compared to age-, weight-, and gender-matched healthy subjects. The Cmaxof roflumilast and roflumilast N-oxide were increased by 3% and 26%, respectively, in Child-Pugh A subjects and by 26% and 40%, respectively, in Child-Pugh B subjects, as compared to healthy subjects
No studies were conducted with topical roflumilast in subjects with renal impairment. Following oral administration in 12 subjects with severe renal impairment, no clinically significant differences in the pharmacokinetics of roflumilast and roflumilast N-oxide were observed.
No formal drug-drug interaction studies were conducted with roflumilast topical foam, 0.3%.
Since a major step in roflumilast metabolism is the N-oxidation of roflumilast to roflumilast N-oxide by CYP3A4 and CYP1A2, drug interaction studies were performed with oral roflumilast and systemic inhibitors of CYP3A4 and CYP1A2
Cytochrome P450 (CYP) Enzymes: