Zoryve

The active ingredient in Zoryve is roflumilast. Roflumilast belongs to a class of medications known as phosphodiesterase-4 inhibitors (PDE4 inhibitors). These medications work by blocking the PDE4 enzyme so that cyclic AMP levels build up in the skin. It is unknown how exactly this mechanism of action proves beneficial for certain skin conditions, but clinical studies looking at efficacy have found positive outcomes after use compared to baseline.

Zoryve Cream is specifically used as a topical treatment option for plaque psoriasis and mild to moderate atopic dermatitis (otherwise known as eczema) in adults and pediatric patients 6 years of age and older. Zoryve Foam, on the other hand, is currently only for use in seborrheic dermatitis in those 9 years of age and older.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide, before using Zoryve. However, the following is a synopsis of the general guidelines for the use of Zoryve:

• Both Zoryve Cream and Zoryve Foam should be used exactly as prescribed. Zoryve is for external use only and should not be used in the eyes, in the vagina, or taken orally.
• Both are usually used once daily. Before using, you should wash your hands with soap and water to ensure a clean application. After use, your hands should be washed again to prevent transfer to other people or unaffected areas of skin. Do not wash your hands after application if this is the skin area being treated.
• Zoryve Cream should be rubbed into the affected area until it can no longer be seen on the skin.
• Zoryve Foam should be applied as a thin layer to the affected area and rubbed in completely. The application site should be dry before use. Since the foam is flammable, care should be taken to avoid heat, smoking, and any open flames during and after application.
• If breastfeeding, do not apply Zoryve directly to the nipple or areola to prevent transfer to your baby. If Zoryve is applied to the chest area, avoid having direct skin-to-skin contact with your baby to prevent transfer.
• If you miss a dose, use it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not use a double dose to make up for a missed one.

The most common side effects of Zoryve Cream 0.3% seen in clinical trials include:

• Diarrhea
• Nausea
• Application site pain
• Headache
• Trouble sleeping
• Upper respiratory tract infections
• Urinary tract infections

The most common side effects of Zoryve Cream 0.15% seen in clinical trials as compared to placebo include:

• Diarrhea
• Nausea and vomiting
• Application site pain
• Headache

The most common side effects of Zoryve Foam seen in clinical trials as compared to placebo include:

• Nausea
• Headache
• Nasopharyngitis or the common cold

Some individuals may experience serious side effects while using Zoryve. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Signs of an allergic reaction, such as hives, rash, difficulty breathing, or swelling of the face, lips, eyes, or tongue

These are not all of the possible adverse reactions of Zoryve. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Zoryve, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including whether you have:

• Liver problems
• Are pregnant or plan to become pregnant
• Are breastfeeding or plan to breastfeed

Do not use Zoryve if you have moderate to severe liver problems.

It can take a couple of weeks of regular use to see the benefits of the medication.

When Zoryve is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how it works or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Erythromycin
• Ketoconazole
• Fluvoxamine
• Enoxacin
• Cimetidine
• Gestodene
• Ethinyl estradiol

Zoryve is available in two dosage forms.

Zoryve cream is available in 60 g tubes that come in the following strengths:

• 0.15% roflumilast cream
• 0.3% roflumilast cream

Zoryve Foam is available in 60 g cans that come in the following strengths:

• 0.3% roflumilast foam

Zoryve should be stored at room temperature, away from light and moisture, and out of reach of children. In addition to the requirements, Zoryve Foam will also need to be kept upright and away from heat or open flames as it is flammable.

Zoryve Cream and Zoryve Foam are manufactured by the pharmaceutical company Arcutis Biotherapeutics.

Currently, there is no generic available for the brand-name Zoryve.

Consult your doctor or pharmacist before starting, stopping, or changing medications while using Zoryve.

It is unknown whether Zoryve is safe in pregnancy. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

It is unknown whether or not Zoryve passes into the breast milk. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.