Topical treatment of acne vulgaris involving the face and/or trunk.
UpToDate/US labeling includes patients 9 years; however, the Taiwan-approved indication is limited to adults and adolescents 12 years. For local prescribing and formulary restrictions, use the Taiwan age threshold. For moderate to severe acne, may be used as part of an appropriate combination regimen.

Topical retinoic acid derivative. Trifarotene is a retinoic acid receptor agonist with preferential selectivity for RAR-γ, the predominant RAR subtype in skin. Receptor activation modulates genes involved in cellular differentiation, follicular keratinization, and inflammation.

Systemic absorption after topical application is limited. Protein binding is approximately 99.9%. Primarily metabolized by CYP2C9, CYP3A4, and CYP2C8; terminal elimination half-life is approximately 2 to 9 hours, with fecal excretion.

No contraindications are listed in the US manufacturer labeling. Canadian labeling additionally contraindicates hypersensitivity to trifarotene or formulation components, eczema or seborrheic dermatitis, and use during pregnancy or when planning pregnancy. Taiwan pregnancy restrictions should be verified against the current local package insert.

X級
No formal pregnancy category is assigned. Although systemic exposure following topical use is low, trifarotene may share the teratogenic potential of other retinoids. Alternative acne therapies are preferred during pregnancy; avoid application to large areas or prolonged use. Local Taiwan labeling verification is required because retinoid pregnancy restrictions may be stricter.

No formal lactation category is assigned. It is unknown whether trifarotene is present in human milk after topical application. Consider the benefits of breastfeeding, maternal treatment need, and potential infant exposure. Do not apply to the nipple or surrounding breast; avoid large treatment areas, prolonged use, and infant skin contact with treated sites.

Application-site irritation 8%, sunburn 3%, and application-site pruritus 2%. Less than 1%: application-site pain, rash, edema, skin erythema, dryness, discoloration, erosion, acne worsening, or allergic dermatitis. Erythema, scaling, dryness, and stinging/burning are most prominent during the first 4 weeks and commonly lessen with continued treatment.

Apply a thin layer to clean, dry affected skin once daily in the evening. One pump covers the face; two pumps cover the upper trunk; one additional pump may be used for the middle/lower back. Avoid eyes, lips, nasal creases, mucosa, broken, eczematous, or sunburned skin. Wash hands after use. A moisturizer may be used. For irritation, reduce application frequency or temporarily interrupt treatment; permanently discontinue if severe and persistent. Minimize UV exposure and use sunscreen/protective clothing.

Children 9 years and adolescents: Same once-daily evening application. Safety and efficacy are not established in children <9 years. Taiwan-approved use begins at age 12 years.

No dosage adjustment is provided in manufacturer labeling. Limited systemic absorption makes an adjustment unlikely.

No dosage adjustment is provided in manufacturer labeling. Limited systemic absorption makes an adjustment unlikely.

Store at 20°C to 25°C; permitted excursions are 15°C to 30°C. Protect from heat. No preparation or reconstitution is required.