Tapinarof

• Approved Uses:
• Treatment of plaque psoriasis in adults and adolescents aged 12 years and older.
• Management of atopic dermatitis in adult patients (approved in certain regions).
• Off-label Uses:
• Investigational treatment of other inflammatory skin disorders such as vitiligo and seborrheic dermatitis (clinical trial phases).

• Adults and Adolescents (≥12 years):
• Apply a thin layer of tapinarof 1% cream once daily to affected areas.
• Treatment duration is typically up to 12 weeks, with continuation based on clinical response and physician discretion.
• Special Populations:
• No dose adjustment required for renal or hepatic impairment due to minimal systemic absorption.
• Route:
• Topical application only.
• Instructions:
• Avoid contact with eyes, lips, and mucous membranes. Wash hands after application unless treating hands.

Tapinarof is a topical aryl hydrocarbon receptor (AhR) agonist. By activating the AhR pathway in keratinocytes and immune cells, it modulates gene expression that restores skin barrier function, reduces inflammation, and normalizes keratinocyte proliferation and differentiation. This results in decreased skin inflammation and improvement of psoriatic plaques and atopic dermatitis lesions.

• Absorption: Minimal systemic absorption after topical use; plasma levels usually undetectable.
• Distribution: Localized mainly within skin layers due to topical administration.
• Metabolism: Limited data; likely hepatic metabolism if absorbed systemically.
• Elimination: Presumed hepatic metabolism with biliary and renal excretion; exact pathways not well characterized due to minimal systemic exposure.
• Onset of Action: Clinical improvement generally seen within several weeks of once-daily application.

• Pregnancy: No adequate human studies available; animal studies show no significant teratogenicity. Use only if benefits outweigh potential risks.
• Lactation: Unknown if excreted in breast milk. Due to minimal absorption, infant exposure is expected to be low. Caution advised.
• Note: Limited data; weigh benefits against risks when prescribing during pregnancy or breastfeeding.

• Topical aryl hydrocarbon receptor (AhR) agonist
• Non-steroidal anti-inflammatory dermatologic agent

• Known hypersensitivity to tapinarof or formulation excipients.
• Presence of active skin infection at treatment site.

• Avoid application on infected, broken, or weeping skin.
• Avoid contact with eyes, lips, and mucous membranes. Rinse immediately if contact occurs.
• Discontinue if severe skin irritation or allergic reaction develops.
• Use with caution in patients with compromised skin barrier.
• Photosensitivity risk: minimize sun exposure and use sun protection during treatment.
• Safety and efficacy not established in children under 12 years.

• Common:
• Folliculitis
• Application site irritation: redness, itching, burning sensation
• Headache (infrequent)
• Serious/Rare:
• Severe allergic reactions (rare)
• Worsening of skin symptoms or secondary infections (rare)

• No clinically significant drug interactions reported due to minimal systemic absorption.
• Avoid concurrent use with other topical agents that may cause skin irritation or increase photosensitivity.

• Recently approved by regulatory agencies (e.g., FDA) for plaque psoriasis treatment in patients aged 12 and older.
• Clinical trials ongoing for broader dermatological indications such as atopic dermatitis and vitiligo.
• Recognized as a non-steroidal alternative suitable for long-term management without typical corticosteroid-related adverse effects.

• Store at 20°C to 25°C (68°F to 77°F).
• Protect from excessive heat, moisture, and direct sunlight.
• Keep the tube tightly closed when not in use.
• Do not freeze.
• Keep out of reach of children.