tapinarof topical (Rx)

Brand and Other Names:Vtama

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

topical cream

  • 10mg/g (1%)

Plaque Psoriasis

Apply thin layer to affected areas once daily

Dosing Considerations

Not for oral, ophthalmic, or intravaginal use

Safety and efficacy not established

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Adverse Effects

>10%

Folliculitis (20%)

Nasopharyngitis, including nasal congestion, pharyngitis, respiratory tract infection (RTI) viral, rhinorrhea, sinus congestion, upper RTI, and viral upper RTI (11%)

1-10%

Contact dermatitis, including dermatitis, hand dermatitis, and rash (7%)

Headache, including migraine and tension headache (4%)

Pruritus, including application site pruritus, generalized pruritus, and genital pruritus (3%)

Influenza, including influenza-like illness (2%)

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Warnings

Contraindications

None

Cautions

Apply medication to skin lesions only, and avoid unaffected areas of skin

Advise patients that medication is for external use only

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Pregnancy & Lactation

Pregnancy

Available data in pregnant women are insufficient to evaluate for drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes

Animal data

  • In animal reproduction studies, subcutaneous administration of tapinarof to pregnant rats and rabbits during the period of organogenesis resulted in no significant adverse effects at doses 268 and 16 times, respectively, the maximum recommended human dose (MRHD)

Lactation

No data available regarding presence of drug in human milk, effects on breastfed infant, or on milk production; drug was detected in rat offspring following subcutaneous administration to pregnant female rats, which suggest that drug was transferred into milk of lactating rats; when drug is present in animal milk, it is likely that the drug will be present in human milk

Developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from therapy or from underlying maternal condition

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Aryl hydrocarbon receptor (AhR) agonist; efficacy of tapinarof in psoriasis is attributed to its binding and activation of the aryl hydrocarbon receptor (AhR), a ligand-dependent transcription factor, leading to the downregulation of proinflammatory cytokines, including interleukin 17

Absorption

Mean ± SD Cmax at day 29: 0.12 ± 0.15 ng/mL

AUC0-last at Day 29: 0.61 ± 0.65 ng.h/mL

Distribution

Protein-bound: 99% in vitro to human plasma protein

Metabolism

Metabolized in liver through multiple pathways, including oxidation, glucuronidation, and sulfation (in vitro)

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Administration

Topical Administration

Apply to skin lesions only, and wash hands after application unless treating hands

Use only externally

Storage

Store at 20-25°C (68-77°F); excursions permitted at 15-30°C (59-86°F)

Do not freeze

Protect from exposure to excessive heat

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Images

No images available for this drug.
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Patient Handout

A Patient Handout is not currently available for this monograph.
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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.