Table of Contents
What is Zoryve?
Zoryve is a medication used to address plaque psoriasis and seborrheic dermatitis by reducing inflammation and symptoms when applied once daily, even in sensitive areas such as the face, skin folds, and hairy regions. Both Zoryve cream and foam are steroid-free, well-tolerated, and exhibit minimal stinging or burning upon application.
Mechanism of Action
Zoryve operates by inhibiting the enzyme PDE4, contributing to the reduction of inflammation and improvement of symptoms associated with plaque psoriasis and seborrheic dermatitis. The active ingredient in Zoryve is roflumilast, classified under phosphodiesterase-4 (PDE4) inhibitors.
FDA Approvals and Expansion
Zoryve cream 0.3% received FDA approval on July 29, 2022, for the treatment of plaque psoriasis in individuals aged 12 and older. Subsequently, on October 06, 2023, the approval was extended to include patients as young as 6 years old. Zoryve foam 0.3% obtained FDA approval on December 25, 2023, specifically for treating seborrheic dermatitis in patients aged 9 and older.
Applications of Zoryve Cream and Foam
Zoryve cream is utilized to alleviate inflammation and symptoms of plaque psoriasis, including sensitive areas like the face, skin folds, and genitalia. It is applicable for individuals aged 6 and older. On the other hand, Zoryve foam is employed for the treatment of seborrheic dermatitis to swiftly clear symptoms and reduce itching. It is a steroid-free topical treatment suitable for patients aged 9 and older.
Related Drugs
Zoryve is listed alongside related or similar drugs, including Siliq, Enstilar, Duobrii, Wynzora, Bimzelx, Cimzia, and Otezla.
Side Effects of Zoryve
Common side effects of Zoryve cream encompass headache, trouble sleeping, nausea, localized pain, upper respiratory tract infections, and urinary tract infections. Zoryve foam commonly leads to nausea, headache, and cold symptoms, with less frequent occurrences of diarrhea and insomnia
Effectiveness of Zoryve
The efficacy of Zoryve cream is supported by the DERMIS-1 study, demonstrating a significant improvement in plaque psoriasis symptoms. Zoryve cream users exhibited a 41.5% improvement compared to 5.8% in the placebo group. Zoryve foam’s effectiveness is evidenced by the STRATUM study, showcasing a 79.5% achievement of clear or almost clear skin in patients compared to 58.0% with a placebo foam.
Important Information
Patients are cautioned against using Zoryve in the presence of certain liver problems, particularly moderate to severe liver impairment. Additionally, Zoryve foam is flammable, necessitating precautions against fire, flames, and smoking during and immediately after application.
Before Using Zoryve
Patients are advised to disclose all medical conditions to their healthcare provider before commencing Zoryve treatment, with specific attention to liver problems.
Pregnancy and Breastfeeding
Concerns related to pregnancy and breastfeeding are addressed, with pregnant individuals advised to discuss potential risks with their healthcare provider. For breastfeeding women, caution is advised, recommending application on the smallest skin area and for the shortest duration, avoiding direct application to the nipple or areola.
How to Use Zoryve
Clear instructions on the application of Zoryve cream and foam are provided, detailing the steps for proper usage, including handwashing after application.
Dosing Information
Specific dosing information is presented for Zoryve cream in the treatment of plaque psoriasis and Zoryve foam for seborrheic dermatitis.
Drug Interactions
Patients are advised to inform their healthcare providers about all medicines taken, including prescription, over-the-counter medications, vitamins, and herbal supplements. Special attention is drawn to potential interactions with systemic CYP3A4 inhibitors and dual inhibitors, as well as oral contraceptives containing gestodene and ethinyl estradiol..
Zoryve Package Insert
Patients are encouraged to review the Zoryve Cream Package Insert or Zoryve Foam Package Insert for comprehensive information about the medication, discussing any medical questions with their healthcare providers.
Storage
Storage instructions for both Zoryve cream and foam are provided, specifying temperature considerations and precautions to avoid flammability and pressure-related issues.
Ingredients
The active ingredient in Zoryve is roflumilast, with the inactive ingredients listed for both Zoryve cream and foam formulations.