zoryve
Zoryve (Roflumilast) is a phosphodiesterase 4 inhibitor used to treat Chronic Obstructive Pulmonary Disease.
Roflumilast · by Arcutis
Available as a generic: Roflumilast
Key facts
- Active ingredient
- Roflumilast
- Drug class
- Phosphodiesterase 4 Inhibitor
- Form
- Spray/Inhaler, Topical
- Strength
- Roflumilast 0.3%
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Arcutis
- What the pharmacy pays
- ~$10.09 for 30 — not your price
- FDA application
- NDA217242
What is Zoryve?
From the FDA label:ZORYVE (roflumilast) topical foam, 0.3%, is a white to off-white foam for topical use. The active ingredient, roflumilast, is a phosphodiesterase 4 (PDE4) inhibitor. The chemical name of roflumilast is 3-cyclopropylmethoxy- N -(3,5-dichloropyridin-4-yl)-4-(difluoromethoxy)benzamide with a molecular formula of C 17 H 14 Cl 2 F 2 N 2 O 3 and the molecular weight of 403.21. The structural formula of roflumilast is: Roflumilast is practically insoluble in water and hexane, sparingly soluble in ethanol, and freely soluble in acetone. Each gram of ZORYVE topical foam, 0.3%, contains 3 mg of roflumilast in a foam base containing ceteareth-10 phosphate, cetearyl phosphate, cetostearyl alcohol, diethylene glycol monoethyl ether, hexylene glycol, isopropyl palmitate, methylparaben, propylparaben, purified water, sodium hydroxide, and white petrolatum. Hydrochloric acid may have been added to adjust pH. ZORYVE topical foam, 0.3%, is dispensed from an aluminum can pressurized with propellant (butane, isobutane, and propane). Chemical Structure
How to use
Zoryve is sold in more than one form (Spray/Inhaler and Topical), and each is dosed differently. The instructions below come from the FDA label for application NDA217242 — follow the label that came with the product you were actually prescribed.
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 [see Warnings and Precautions (5.1) ] . ZORYVE foam, 0.3%, is for topical use only and not for ophthalmic, oral, or intravaginal use. Apply once daily to affected areas. ( 2 ) For topical use only. Not for ophthalmic, oral, or intravaginal use. ( 2 )
Side effects
The most common adverse reactions (reported in ≥ 1% of patients) are: Seborrheic dermatitis : nasopharyngitis, nausea, and headache. ( 6.1 ) Plaque psoriasis of the scalp and body : headache, diarrhea, nausea, and nasopharyngitis. ( 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. Seborrheic Dermatitis In two multicenter, randomized, double-blind, vehicle-controlled trials (Trial 203 and STRATUM), 683 adult and pediatric subjects 9 years of age or older with seborrheic dermatitis were treated with ZORYVE foam, 0.3%, or vehicle foam once daily for 8 weeks [see Clinical Studies (14.1) ]. Table 1 presents adverse reactions that occurred in at least 1% of subjects treated with ZORYVE foam, 0.3%. Table 1: Adverse Reactions Reported in ≥1% of Adult and Pediatric Subjects 9 Years of Age and Older with Seborrheic Dermatitis Treated with ZORYVE Foam, 0.3%, for 8 Weeks in Trial 203 and Trial STRATUM Adverse Reaction ZORYVE foam, 0.3% (N=458) n (%) Vehicle foam (N=225) n (%) Nasopharyngitis 7 (1.5)…
Warnings
Important safety information
Flammability : The propellants in ZORYVE foam, 0.3%, are flammable. Avoid fire, flame, and smoking during and immediately following application. ( 5.1 ) 5.1 Flammability The propellants in ZORYVE foam, 0.3%, are flammable. Avoid fire, flame, and smoking during and immediately following application.
Who should not take Zoryve
ZORYVE foam, 0.3%, 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 )
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 foam, 0.3%, 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 foam, 0.3%, weigh the potential for increased adverse reactions against benefit. ( 7.1 ) 7.1 Effects of Other Drugs on ZORYVE Foam, 0.3% Drugs that Inhibit Cytochrome P450 (CYP) Enzymes No formal drug-drug interaction studies were conducted with ZORYVE foam, 0.3%; however, the co-administration of oral 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 foam, 0.3%, weigh the potential for increased adverse reactions against benefit [see Clinical Pharmacology (12.3) ] . Oral Contraceptives Containing Gestodene and Ethinyl Estradiol The 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 foam, 0.3%, weigh the potential for increased adverse reactions against benefit [see Clinical Pharmacology (12.3) ] .
Drug class
May treat (source: NIH RxClass)
See how Zoryve ranks — best-rated phosphodiesterase 4 inhibitor for:
Dosage forms
Spray/Inhaler and Topical
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
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Frequently asked questions
- What does Zoryve treat?
- Zoryve (Roflumilast) may be used to treat chronic obstructive pulmonary disease, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How much does Zoryve cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $10.09 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Zoryve?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Zoryve. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Zoryve?
- Zoryve is marketed by Arcutis. You can see Arcutis's full profile, rating, and other products on pharmaranks.
- Is Zoryve a brand-name or generic drug?
- Zoryve is a brand-name product with the active ingredient Roflumilast. Lower-cost generic equivalents containing Roflumilast are available — ask your pharmacist.
- Is Zoryve available over the counter?
- No. Zoryve is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Zoryve come in?
- Zoryve is currently marketed as spray/inhaler and topical, per the FDA's National Drug Code Directory.
- What class of drug is Zoryve?
- Zoryve is classified as phosphodiesterase 4 inhibitor, per the FDA's Established Pharmacologic Class.
- Is Zoryve FDA-registered?
- Zoryve is on record with the U.S. FDA under application number NDA217242. You can verify this on its official FDA label.
- Is Zoryve safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Zoryve. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Zoryve?
- Zoryve's side effects are taken directly from its FDA label. From the label: The most common adverse reactions (reported in ≥ 1% of patients) are: Seborrheic dermatitis : nasopharyngitis, nausea, and headache. ( 6.1 ) Plaque psoriasis of the scalp and body : headache, diarrhea, nausea, and nasopharyngitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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