Zoryve Cream

Zoryve is a topical prescription cream used to treat the symptoms of plaque psoriasis in adults and children over the age of 12.

• Zoryve may be used alone or with other medications.
• Zoryve belongs to a class of drugs called PDE-4 Inhibitors, Topical. 
• It is not known if Zoryve is safe and effective in children younger than 12 years of age. 

The use of Zoryve is contraindicated in the following condition:

• Moderate to severe liver impairment (Child-Pugh B or C)

Zoryve may cause serious side effects including:

• hives, 
• difficulty breathing, 
• swelling of your face, lips, tongue, or throat, 
• dizziness, 
• mood or behavior changes, 
• anxiety, 
• depression, 
• trouble sleeping, 
• impulsive thoughts, 
• thoughts of self-harm, 
• rapid and unintended weight loss, 
• pain or burning when you urinate, and 
• tremors

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Zoryve include:

• nausea, 
• diarrhea, 
• loss of appetite, 
• minor weight loss, 
• headache, 
• dizziness, 
• occasional sleep problems, 
• back pain, and 
• flu symptoms 

Tell the doctor if you have any side effect that bothers you or that does not go away.

Call your doctor immediately if you experience any of the following symptoms or serious side effects while using this drug:

• Serious heart symptoms include fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness;
• Severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
• Severe nervous system reaction with very stiff muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out; or
• Serious eye symptoms include blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.

This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.

• Apply Zoryve to affected areas once daily and rub in completely. Wash hands after application, unless Zoryve is for treatment of the hands.
• Zoryve is for topical use only and not for ophthalmic, oral, or intravaginal use.

No formal drug-drug interaction studies were conducted with Zoryve.

Drugs That Inhibit Cytochrome P450 (CYP) Enzymes

• The coadministration of roflumilast with systemic CYP3A4 inhibitors or dual inhibitors that inhibit both CYP3A4 and CYP1A2 simultaneously (e.g., erythromycin, ketoconazole, fluvoxamine, enoxacin, cimetidine) may increase roflumilast systemic exposure and may result in increased adverse reactions. The risk of such concurrent use should be weighed carefully against benefit.

Oral Contraceptives Containing Gestodene And Ethinyl Estradiol

• The coadministration of roflumilast 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.

• There are no randomized clinical trials of oral or topical roflumilast in pregnant women. Consult your doctor if you are pregnant.
• There is no information regarding the presence of Zoryve in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Zoryve and any potential adverse effects on the breastfed infant from Zoryve or from the underlying maternal condition.