Overview
11 DESCRIPTION VTAMA (tapinarof) cream contains tapinarof as the active ingredient. Tapinarof is an aryl hydrocarbon receptor agonist. Tapinarof is a white to pale brown powder. Chemically, tapinarof is 3, 5-dihydroxy-4-isopropyl- trans -stilbene, also known as (E)-2-isopropyl-5-styrylbenzene-1,3-diol, with the empirical formula C 17 H 18 O 2 , a molecular weight of 254.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Tapinarof is an aryl hydrocarbon receptor (AhR) agonist. The specific mechanisms by which VTAMA cream exerts its therapeutic actions are unknown. 12.2 Pharmacodynamics Pharmacodynamics of VTAMA cream are unknown. Cardiac Electrophysiology At the approved recommended dosage, VTAMA cream does not prolong the QTc interval to any clinically relevant extent. 12.3 Pharmacokinetics The plasma concentrations of tapinarof were higher in pediatric subjects 2 years of age and older with atopic dermatitis when compared to adult subjects with plaque psoriasis. Absorption Adults with Plaque Psoriasis No accumulation was observed with repeat topical application.
Indications
- 1 INDICATIONS AND USAGE VTAMA cream, 1% is an aryl hydrocarbon receptor agonist indicated for: the topical treatment of plaque psoriasis in adults. ( 1.1 ) the topical treatment of atopic dermatitis in adults and pediatric patients 2 years of age and older. ( 1.2 ) 1.1 Plaque Psoriasis VTAMA ® cream is indicated for the topical treatment of plaque psoriasis in adults. 1.2 Atopic Dermatitis VTAMA cream is indicated for the topical treatment of atopic dermatitis in adults and pediatric patients 2 years of age and older.
Common Doses
- Refer to label
Dosage
2 DOSAGE AND ADMINISTRATION Apply a thin layer of VTAMA cream to affected areas once daily. Wash hands after application, unless VTAMA cream is for treatment of the hands. VTAMA cream is not for oral, ophthalmic, or intravaginal use. Apply a thin layer of VTAMA cream to affected areas once daily. ( 2 ) VTAMA cream is not for oral, ophthalmic, or intravaginal use. ( 2 )
Contraindications
- 4 CONTRAINDICATIONS None. None. ( 4 )
Side Effects
- 6 ADVERSE REACTIONS In plaque psoriasis, the most common adverse reactions (incidence ≥ 1%) were folliculitis, nasopharyngitis, contact dermatitis, headache, pruritus, and influenza. ( 6.1 ) In atopic dermatitis, the most common adverse reactions (incidence ≥ 1%) were upper respiratory tract infection, folliculitis, lower respiratory tract infection, headache, asthma, vomiting, ear infection, pain in extremity, and abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Organon LLC, a subsidiary of Organon & Co., at 1-844-674-3200 or FDA at 1-800-FDA-1088 or www.fda.
Interactions
- No major interactions listed on the FDA label. Always consult a healthcare professional.