ZORYVE Dosage & Rx Info | Uses, Side Effects

Zoryve Generic Name & Formulations

Legal Class

General Description

Roflumilast 0.3%; crm.

Pharmacological Class

Phosphodiesterase 4 (PDE4) inhibitor.

How Supplied

Crm—60g

Manufacturer

Arcutis Biotherapeutics, Inc.

Generic Availability

Mechanism of Action

Roflumilast and its active metabolite (roflumilast N-oxide) are inhibitors of phosphodiesterase 4 (PDE4). Roflumilast and roflumilast N-oxide inhibition of PDE4 (a major cyclic-3′,5′-adenosine monophosphate (cyclic AMP)-metabolizing enzyme) activity leads to accumulation of intracellular cyclic AMP. The specific mechanism(s) by which roflumilast exerts its therapeutic action is not well defined.

Zoryve Indications

Indications

Plaque psoriasis, including intertriginous areas.

Zoryve Dosage and Administration

Adults and Children

<6yrs: not established. ≥6yrs: Apply to the affected area(s) once daily; rub in completely.

Zoryve Contraindications

Contraindications

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

Zoryve Boxed Warnings

Not Applicable

Zoryve Warnings/Precautions

Warnings/Precautions

Not for oral, ophthalmic, or intravaginal use. Labor & delivery: avoid. Pregnancy. Nursing mothers: avoid direct infant exposure.

Zoryve Pharmacokinetics

Absorption

Mean ± SD systemic exposure (AUC_0-24): 72.7 ± 53.1 (adults); 25.1 ± 24.0 (adolescents 13–16yrs); 75.6 ± 87.3 (pediatrics 6–<12yrs).

Distribution

Plasma protein bound: ~99%.

Metabolism

Cytochrome P450 and conjugation.

Elimination

Half-life: 4.0 days.

Zoryve Interactions

Interactions

May be potentiated by systemic CYP3A4 inhibitors, dual CYP3A4/CYP1A2 inhibitors (eg, erythromycin, ketoconazole, fluvoxamine, enoxacin, cimetidine), oral contraceptives containing gestodene + ethinyl estradiol; consider risks vs benefits prior to concomitant use.

Zoryve Adverse Reactions

Adverse Reactions

Diarrhea, headache, insomnia, application site pain, upper respiratory tract infections, urinary tract infections.

Zoryve Clinical Trials

See Literature

Zoryve Note