ZORYVE 3 mg/g
roflumilast · AEROSOL, FOAM · Arcutis Biotherapeutics, Inc.
ZORYVE is a aerosol, foam containing roflumilast at 3 mg/g, taken topical. Manufactured by Arcutis Biotherapeutics, Inc..
Key Facts
- Brand Name
- ZORYVE
- Generic Name
- roflumilast
- NDC Code (Product)
80610-430- Manufacturer
- Arcutis Biotherapeutics, Inc.
- Strength
- 3 mg/g
- Dosage Form
- AEROSOL, FOAM
- Route
- TOPICAL
- Marketing Status
- Application #
- NDA217242
- Drug Class
- Phosphodiesterase 4 Inhibitor [EPC]
- Marketing Start
- 12/15/2023
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE ZORYVE cream is a phosphodiesterase 4 inhibitor: Plaque Psoriasis 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. ( 1.1 ) Atopic Dermatitis 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. ( 1.2 ) ZORYVE cream, 0.05%, is indicated for the topical treatment of mild to moderate atopic dermatitis in pediatric patients 2 to 5 years of age. ( 1.2 ) 1.1 Plaque Psoriasis ZORYVE ® cream, 0.3%, is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 years of age and older. 1.2 Atopic Dermatitis ZORYVE cream, 0.15%, is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older. ZORYVE cream, 0.05%, is indicated for topical treatment of mild to moderate atopic dermatitis in pediatric patients 2 to 5 years of age.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Plaque Psoriasis Use ZORYVE cream, 0.3%, for the treatment of plaque psoriasis in adult and pediatric patients 6 years of age and older. Atopic Dermatitis Use ZORYVE cream, 0.15%, for the treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older. Use ZORYVE cream, 0.05%, for the treatment of mild to moderate atopic dermatitis in pediatric patients 2 to 5 years of age. Administration Instructions Apply ZORYVE cream to affected areas once daily and rub in completely. Wash hands after application. ZORYVE cream is for topical use only and not for ophthalmic, oral, or intravaginal use. For topical use only. ( 2 ) Not for ophthalmic, oral, or intravaginal use. ( 2 ) Plaque Psoriasis Apply ZORYVE cream, 0.3%, once daily to affected areas. ( 2 ) Atopic Dermatitis Adult and Pediatric Patients 6 Years of Age and Older Apply ZORYVE cream, 0.15%, once daily to affected areas. ( 2 ) Pediatric Patients 2 to 5 Years of Age Apply ZORYVE cream, 0.05%, once daily to affected areas. ( 2 )
Contraindications
4 CONTRAINDICATIONS ZORYVE cream is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C) [see Use in Specific Populations (8.6) , Clinical Pharmacology (12.3) ] . Moderate to severe liver impairment (Child-Pugh B or C). ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Co-administration of roflumilast with systemic CYP3A4 inhibitors or dual inhibitors that inhibit both CYP3A4 and CYP1A2 simultaneously may increase roflumilast systemic exposure and may result in increased adverse reactions. If these products are co-administered with ZORYVE cream, weigh the potential for increased adverse reactions against benefit. ( 7.1 ) Co-administration of roflumilast with oral contraceptives containing gestodene and ethinyl estradiol may increase roflumilast systemic exposure and may result in increased adverse reactions. If these products are co-administered with ZORYVE cream, weigh the potential for increased adverse reactions against benefit. ( 7.1 ) 7.1 Effects of Other Drugs on ZORYVE Cream Drugs that Inhibit Cytochrome P450 (CYP) Enzymes No formal drug-drug interaction studies were conducted with ZORYVE cream; however, the co-administration of roflumilast with systemic CYP3A4 inhibitors or dual inhibitors that inhibit both CYP3A4 and CYP1A2 simultaneously may increase roflumilast systemic exposure and may result in increased adverse reactions. If these products are co-administered with ZORYVE cream, weigh the potential for increased a…
Adverse Reactions
6 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 infection, and urinary tract infection. ( 6.1 ) Atopic Dermatitis: headache, nausea, application site pain, diarrhea, vomiting, upper respiratory tract infection, rhinitis, and conjunctivitis. ( 6.1 ) 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. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Plaque Psoriasis Adult and Pediatric Subjects 6 Years of Age and Older In two multicenter, randomized, double-blind, vehicle-controlled trials (DERMIS-1 and DERMIS-2), 881 adult and pediatric subjects 6 years of age or older with plaque psoriasis were treated with ZORYVE cream, 0.3%, or vehicle cream once daily for 8 weeks [see Clinical Studies (14.1) ] . The propo…
Frequently Asked Questions
What is ZORYVE used for?
ZORYVE contains roflumilast. It is a aerosol, foam taken topical. Consult your doctor for specific uses.
Is ZORYVE a controlled substance?
ZORYVE is not classified as a controlled substance by the DEA.
What is the generic name for ZORYVE?
The generic name for ZORYVE is roflumilast. There are 9 other brand versions of roflumilast.
What is the NDC code for ZORYVE 3 mg/g?
The NDC (National Drug Code) for ZORYVE 3 mg/g is 80610-430, listed by Arcutis Biotherapeutics, Inc..