Zoryve is a prescription cream used to treat plaque psoriasis.

Zoryve contains roflumilast, which belongs to the class of drugs called phosphodiesterase-4 (PDE4) inhibitors. It works by reducing inflammation in plaque psoriasis.

What is Zoryve used for?

Zoryve is used to treat plaque psoriasis, including psoriasis on areas with skin folds (intertriginous skin) in people 12 years of age and older.

It is not known if this medicine is safe and effective in children under 12 years of age.

Zoryve is for use on the skin (topical use) only. Do not use in or on your eyes, mouth, or vagina.

Who should not use Zoryve?

Do not use Zoryve if you have certain liver problems.

Before using Zoryve

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

• have liver problems
• are pregnant or plan to become pregnant. It is not known if Zoryve will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Zoryve passes into your breast milk.

Talk to your healthcare provider about the best way to feed your baby during treatment with Zoryve.

Breastfeeding women using Zoryve should use only on the smallest area of the skin and for the shortest time needed. Do not apply directly to the nipple and areola to avoid contact with your baby.

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

Usual Adult Dose for Plaque Psoriasis

Apply once daily to affected areas.

Comments: For topical use only. Not for ophthalmic, oral, or intravaginal use.
Use: topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older.

Do not use Zoryve if you have certain liver problems.

Before using Zoryve

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

• have liver problems
• are pregnant or plan to become pregnant. It is not known if Zoryve will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Zoryve passes into your breast milk.

Talk to your healthcare provider about the best way to feed your baby during treatment with Zoryve.

Breastfeeding women using Zoryve should use only on the smallest area of the skin and for the shortest time needed. Do not apply directly to the nipple and areola to avoid contact with your baby.

The most common side effects include:

• diarrhea
• headache
• trouble sleeping
• nausea
• application site pain
• upper respiratory tract infections
• urinary tract infections (UTIs)

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

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

Especially tell your doctor if you are taking any of the following medicines:

• erythromycin
• ketoconazole
• fluvoxamine
• enoxacin
• cimetidine
• birth control medicines containing gestodene and ethinyl estradiol.