Pronunciation: zor-EEV
Generic name: roflumilast topical
Dosage form: cream 0.3%, foam 0.3%
Drug class: Selective phosphodiesterase-4 inhibitors

Medically reviewed by Melisa Puckey, BPharm. Last updated on Jan 22, 2024.

What is Zoryve?

Zoryve is used for plaque psoriasis and seborrheic dermatitis to reduce inflammation and symptoms when applied once daily anywhere on the body, including sensitive areas like face or skin folds and hairy areas. Zoryve cream and foam are steroid free and is well tolerated with very little stinging or burning. 

 Zoryve works (mechanism of action) by inhibiting the enzyme PDE4, which helps to reduce inflammation and improve the symptoms of plaque psoriasis and seborrheic dermatitis. Zoryve contains the active ingredient roflumilast, which belongs to the class of drugs called phosphodiesterase-4 (PDE4) inhibitors.

Zoryve cream 0.3% became an FDA-approved medicine on July 29, 2022, to treat plaque psoriasis in people 12 years and older. On October 06, 2023, the FDA expanded the approval to include patients 6 years and older.  Zoryve foam 0.3% received FDA approval on December 25, 2023, to treat seborrheic dermatitis in patients 9 years of age and older.

What are Zoryve cream and Zoryve foam used for?

Zoryve cream is used to reduce inflammation and symptoms of plaque psoriasis, including psoriasis on sensitive areas, including the face, skin folds, and genitalia. Zoryve can be used in people 6 years of age and older. This cream should not be applied to the eyes, mouth, or vagina. The cream base is a non-greasy, moisturizing cream that absorbs quickly and spreads easily. It does not include sensitizing ingredients or irritants such as propylene glycol, polyethylene glycol, isopropyl alcohol, ethanol, or fragrances.

Zoryve foam is used for seborrheic dermatitis to help rapidly clear seborrheic dermatitis and also reduce the symptoms of itch. Zoryve foam is a once-daily, steroid-free topical treatment that can be used anywhere on the body, including hairy areas.  Zoryve foam can be used for seborrheic dermatitis in patients 9 years of age and older.

Related/similar drugs

Cimzia, Otezla, Taltz, Sotyktu, Humira, Enbrel, Remicade

Zoryve side effects

The most common Zoryve cream side effects include headache, trouble sleeping, nausea, pain where cream was applied, upper respiratory tract infections, and urinary tract infections, which occurred in at least 1% of patients.

The most common Zoryve foam side effects include nausea, headache, and cold symptoms (runny nose, congestion), which occurred in greater than 1% of patients. Less common side effects of Zoryve foam are diarrhea and sleep problems (insomnia) these occurred in less than 1% of patients

These are not all of the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Arcutis Biotherapeutics, Inc. by calling 1-844-692-6729.

How well does Zoryve work?

How well dose Zoryve cream work?

In the DERMIS-1, an 8-week study showed that using Zoryve cream, 41.5% of patients had significant improvement in their plaque psoriasis compared to 5.8% who used a placebo cream. Zoryve cream also improved psoriasis itching, which started as early as week 2 in the Zoryve cream treated patients. By week 8, 67.5% of the Zoryve cream treated patients had a reduction in psoriasis itchiness compared to 26.8% of the placebo group. 

Plaque psoriasis improvement was measured using the Investigator’s Global Assessment (IGA) scale. The IGA scale scores the psoriasis ranging from 0 (clear) to 4 (severe). Treatments work well if the score becomes 0 (clear) or 1 (almost clear) and the score has dropped at least 2 levels.

Itchiness is measured using the Worst Itch Numeric Rating Scale (WI-NRS), which rates itch from 0 (no itch) to 10 (worst imaginable itch). The treatment is considered successful if there is at least a 4-point reduction WI-NRS score, which must have been 4 or higher at the start of treatment.

How well does Zoryve foam work?

In the STRATUM study Zoryve foam started working at week 2 and by week 8 results showed that using  Zoryve foam 79.5% patients having clear or almost clear skin compared to 58.0% patients using a placebo foam. Using Zoryve foam 50.6% of patients had complete clearance of seborrheic dermatitis (IGA=0) at Week 8.

Seborrheic dermatitis improvement was measured using the Investigator’s Global Assessment (IGA) scale. The IGA scale scores the seborrheic dermatitis ranging from 0 (clear) to 4 (severe). Treatments work well if the score becomes 0 (clear) or 1 (almost clear) and the score has dropped at least 2 levels.

Important Information

Do not use Zoryve if you have certain liver problems, including moderate to severe liver impairment. 

Zoryve foam is flammable. Avoid fire, flame, and smoking when applying and right after you apply it.

Before using this medicine

Before you start treatment, tell your healthcare provider about all of your medical conditions, including if you:

• have liver problems.

Pregnancy

Tell your healthcare provider if you are pregnant or plan to become pregnant, as is not known if the active ingredient roflumilast will harm your unborn baby.

Breastfeeding

Tell your healthcare provider if you are breastfeeding or planning to breastfeed. Talk to your healthcare provider about the best way to feed your baby during treatment with this cream.

Breastfeeding women using the cream or foam should use it on the smallest area of the skin and for the shortest time needed. Do not apply this cream or foam directly to the nipple or areola if you are breastfeeding to avoid contact of the product with your baby.

How should I use Zoryve?

How to use Zoryve cream

• Apply the cream to the psoriasis plaques 1 time a day. Rub the cream in completely until you no longer see it on your skin.
• Wash your hands after applying the cream unless your hands are being treated. If someone else applies the cream for you, they should wash their hands after applying the cream.
• Use this cream exactly as your healthcare provider tells you to use it.

How to use Zoryve foam

Before applying the foam for the first time, gently pull back on the nozzle to break the plastic piece at the base. 

Step 1: Shake the can well before use.
Step 2: Turn the can upside down and press the nozzle to dispense a small amount into your hand. 
Step 3: Apply enough foam to cover all the affected areas with a thin layer, rubbing the foam in completely. Apply to skin and scalp when they are not wet. If you are treating seborrheic dermatitis of your scalp, part the hair so that the foam can be applied directly to the affected area on the skin. 
Step 4: Wash your hands. If someone else applies it for you, they should wash their hands after applying it. 

Zoryve Dosing information

Zoryve Cream Dose for Plaque Psoriasis: Apply once daily to affected areas

Zoryve Foam Dose for Seborrheic Dermatitis: Apply once daily to affected areas

Comments: For topical use only. Not for ophthalmic, oral, or intravaginal use.

What other drugs will affect Zoryve?

Tell your healthcare provider about the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Using Zoryve cream or foam with medicines that are systemic CYP3A4 inhibitors or dual inhibitors that inhibit both CYP3A4 and CYP1A2 simultaneously may increase the active ingredient romflumilast systemic exposure and may increase side effects. It is important to  weigh up the potential for increased adverse reactions against benefit if these products are used together with Zoryve cream or foam.

Using Zoryve cream with oral contraceptives containing gestodene and ethinyl estradiol may increase roflumilast systemic exposure and may result in increased side effects. The risk of such concurrent use should be weighed carefully against benefit. 

This list is not complete. Not all possible drug interactions are listed here.

Zoryve Package Insert

Review the Zoryve Cream Package Insert or Zoryve Foam Package Insert for more detailed information about this medicine. Discuss any medical questions you have with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

Storage

Cream storage

• Store at room temperature from 68°F to 77°F (20°C to 25°C).

Foam storage

• Store at room temperature between 68°F to 77°F (20°C to 25°C).  
• This foam is flammable. Keep away from heat and flame.  
• The contents foam are under pressure. Do not puncture or burn the can. Do not expose to heat or store at temperatures above 120°F (49°C).  
• Do not freeze.  Store the can upright. 

Ingredients

Active ingredient: roflumilast

Cream inactive ingredients: 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.

Foam inactive ingredients: 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. Propellants: butane, isobutane, and propane. 

Company

Zoryve is marketed by: Arcutis Biotherapeutics, Inc. Westlake Village, CA 91361.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer