Atopic dermatitis: Topical: Apply a thin layer to the affected area once daily.
Plaque psoriasis: Topical: Apply a thin layer to the affected area once daily; the treatment period in clinical trials was up to 12 weeks (Ref).
The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.
Altered kidney function: Topical: No dosage adjustment necessary for any degree of kidney dysfunction (minimal systemic absorption (Ref)) (Ref).
Hemodialysis, intermittent (thrice weekly): Topical: No supplemental dose or dosage adjustment necessary (minimal systemic absorption (Ref)) (Ref).
Peritoneal dialysis: Topical: No dosage adjustment necessary (minimal systemic absorption (Ref)) (Ref).
CRRT: Topical: No dosage adjustment necessary (Ref).
PIRRT (eg, sustained, low-efficiency diafiltration): Topical: No dosage adjustment necessary (Ref).
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults, unless otherwise noted.
>10%:
Dermatologic: Folliculitis (children, adolescents, adults: 9% to 20%)
Respiratory: Nasopharyngitis (11%), upper respiratory tract infection (children, adolescents, adults: 12%)
1% to 10%:
Dermatologic: Contact dermatitis (7%), pruritus (3%)
Gastrointestinal: Abdominal pain (children, adolescents, adults: 1%), vomiting (children, adolescents, adults: 2%)
Infection: Influenza (2%)
Local: Application-site reaction (children, adolescents, adults: 4%)
Nervous system: Headache (children, adolescents, adults: 4%)
Neuromuscular & skeletal: Limb pain (children, adolescents, adults: 2%)
Otic: Ear disease (children: 2%; including otitis externa, otitis media)
Respiratory: Asthma (children, adolescents, adults: 2%), lower respiratory tract infection (children, adolescents, adults: 5%)
<1%: Dermatologic: Urticaria
There are no contraindications listed in the manufacturer's labeling.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, External:
Vtama: 1% (60 g) [contains benzoic acid, edetate (edta) disodium, polysorbate 80, propylene glycol]
No
Cream (Vtama External)
1% (per gram): $30.20
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Topical: For topical use only; not for oral, ophthalmic, or intravaginal use. Apply as a thin layer to the affected area. Wash hands after use (unless used for treatment of the hands).
Atopic dermatitis: Treatment of atopic dermatitis in adults and pediatric patients ≥2 years of age.
Plaque psoriasis: Treatment of plaque psoriasis in adults.
None known.
There are no known significant interactions.
Adverse events were not observed in animal reproduction studies following SUBQ administration.
It is not known if tapinarof is present in breast milk following topical administration.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Binds to and activates the aryl hydrocarbon receptor (AhR), a ligand-dependent transcription factor that regulates cytokine and skin-barrier-protein expression and antioxidant activity (Lebwohl 2021). The specific mechanism of action is not known (manufacturer's labeling).
Absorption: Minimally absorbed; serum concentrations range from undetectable to 0.9 ± 1.4 ng/mL on day 1 and 0.12 ± 0.15 ng/mL on day 29 (Jett 2022).
Protein binding: 99% (in vitro).
Metabolism: Hepatic, via multiple pathways (oxidation, glucuronidation, and sulfation) in vitro.