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Tapinarof: Drug information

Tapinarof: Drug information
(For additional information see "Tapinarof: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Vtama
Pharmacologic Category
  • Aryl Hydrocarbon Receptor Agonist
Dosing: Adult
Plaque psoriasis

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).

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.

>10%:

Dermatologic: Folliculitis (20%)

Respiratory: Nasopharyngitis (11%)

1% to 10%:

Dermatologic: Contact dermatitis (7%), pruritus (3%)

Infection: Influenza (2%)

Nervous system: Headache (4%)

<1%: Dermatologic: Urticaria

Contraindications

There are no contraindications listed in the manufacturer's labeling.

Dosage Forms: US

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]

Generic Equivalent Available: US

No

Pricing: US

Cream (Vtama External)

1% (per gram): $27.70

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

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).

Use: Labeled Indications

Plaque psoriasis: Treatment of plaque psoriasis in adults.

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

Adverse events were not observed in animal reproduction studies following SUBQ administration.

Breastfeeding Considerations

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.

Mechanism of Action

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 related to psoriasis treatment is not known (manufacturer's labeling).

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Minimally absorbed; serum concentrations range from undetectable to 0.9 ± 1.4 ng/mL.

Protein binding: 99% (in vitro).

Metabolism: Hepatic, via multiple pathways (oxidation, glucuronidation, and sulfation) in vitro.

  1. Lebwohl MG, Stein Gold L, Strober B, et al. Phase 3 trials of tapinarof cream for plaque psoriasis. N Engl J Med. 2021;385(24):2219-2229. doi:10.1056/NEJMoa2103629 [PubMed 34879448]
  2. Vtama (tapinarof) [prescribing information]. Long Beach, CA: Dermavant Sciences Inc; May 2022.
Topic 138764 Version 23.0

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