Zoryve
Pronunciation: zor-EEV
Generic name: roflumilast topical
Dosage form: cream (0.15%), cream (0.3%), foam (0.3%)
Drug class: Selective phosphodiesterase-4 inhibitors
What is Zoryve?
Zoryve cream is used for plaque psoriasis and atopic dermatitis, and Zoryve foam is used for seborrheic dermatitis, to improve itching and inflammation and control skin conditions. Zoryve is a once-daily, steroid-free cream or foam that can be used long term anywhere on the body, including sensitivero areas like face or skin folds and hairy areas. Zoryve cream and foam are 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.
What are Zoryve cream and Zoryve foam used for?
Zoryve FDA approval is to treat:
- Plaque psoriasis (0.3% cream) in patients 6 years and older.
- Atopic dermatitis (0.15% cream) in patients 6 years and older.
- Seborrheic dermatitis (0.3% foam) in patients 9 years and older.
Zoryve cream is used for plaque psoriasis, including psoriasis on sensitive areas, including the face, skin folds, and genitalia. Zoryve (0.3%) cream is used for plaque psoriasis in people 6 years of age and older. 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. This cream should not be applied to the eyes, mouth, or vagina.
Zoryve cream for atopic dermatitis. Zoryve cream (0.15%) is used for the treatment of mild to moderate atopic dermatitis in patients 6 years of age and older. Zoryve cream helps clear atopic dermatitis, reduces itch and can be used long-term to control dermatitis. This cream should not be applied to the eyes, mouth, or vagina.
Zoryve for seborrheic dermatitis. Zoryve foam (0.3%) is used 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. This foam should not be applied to the eyes, mouth, or vagina.
Zoryve side effects
Common Zoryve Cream Side Effects
The most common Zoryve cream 0.3% side effects include
- Diarrhea (3.1%)
- Headache (2.4%)
- Insomnia (1.4%)
- Nausea (1.2%)
- Application site pain(1.0%)
- Upper respiratory infections (1.0%)
- Urinary tract infections (1.0%)
The most common Zoryve cream 0.15% side effects for atopic dermatitis are
- Headache (2.9%)
- Nausea (1.9%)
- Application site pain(1.5%)
- Diarrhea (1.5%)
- Vomiting (1.5%
Common Zoryve Foam Side Effects
The most common Zoryve foam side effects include:
- Nausea (1.3%)
- Headache (1.1%)
- Cold symptoms such as runny nose and congestion (1.5%).
- 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.
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How well does Zoryve work?
Plaque Psoriasis – DERMIS-1 Study (NCT04211363) and DERMIS-2 (NCT04211389)
- 41.5% of Zoryve patients had clear or almost clear skin in 8 weeks (vs. 5.8% on placebo). Measured using Investigator’s Global Assessment (IGA) score
- 67.5% of patients reported a 4-point reduction in itch by week 8 (measured using the Worst Itch-Numeric Rating Scale (WI-NRS) score)
Atopic Dermatitis – INTEGUMENT-1 (NCT04773587)
- 33.6% of Zoryve patients had a successful improvement of itch within 4 weeks (measured using the WI-NRS score)
- Itch relief started within 24 hours of application.
Seborrheic Dermatitis – STRATUM [NCT04973228]
- 79.5% of Zoryve patients had clear or almost clear skin in 8 weeks vs. 58% placebo (measured using IGA score)
- 50.7% achieved complete clearance by week 8.
Warnings
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 it 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?
Zoryve Cream instructions
- Apply a thin layer to affected areas once daily.
- Rub in completely until it disappears.
- Wash hands after application (unless treating hands).
Zoryve Foam instructions
- Apply a thin layer to affected areas once daily.
- Shake well before use.
- Turn the can upside down and dispense it into your hand.
- Apply to dry skin and rub in completely.
- Wash hands after application.
Zoryve Dosing information
Zoryve Cream Dose for Atopic Dermatitis or 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 roflumilast 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.
References
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Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.