Stimulates retinoic acid receptors, resulting in anti-inflammatory effects.
Decreased severity of acne vulgaris.
Absorption: Minimal systemic absorption.
Protein Binding: >99%.
Metabolism and Excretion: Primarily metabolized by CYP2C8, CYP2C9, and CYP3A4. Primarily excreted in feces.
Half-life: 2–9 hr.
TIME/ACTION PROFILE (improvement in lesions)
|Topical||within 12 wks||Unknown||Unknown|
- Eczema, cuts/abrasions, or sunburned skin.
Use Cautiously in:
- History of local irritation/sensitivity;
- Unprotected sunlight/sunlamp exposure;
- OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk (risk may be less with topical vs. oral retinoids);
- Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
- Pedi: Children <9 yr (safety and effectiveness not established).
Adverse Reactions/Side Effects
Local: burning/stinging, erythema, itching, photosensitivity, scaling
* CAPITALS indicate life-threatening.
Underline indicate most frequent.
Topical (Adults and Children ≥9 yr): Apply once daily in the evening.
Topical cream: 0.005%
- Assess skin lesions before and periodically during therapy.
Cleanse the area to be treated; pat dry. Apply a thin layer of cream to affected areas once daily, in the evening, on clean and dry skin. One pump actuation should be enough to cover the face (forehead, cheeks, nose, chin). Two actuations of pump should be enough to cover the upper trunk (reachable upper back, shoulders chest). One additional pump actuation may be used for middle and lower back if acne is present. Avoid contact with the eyes, lips, paranasal creases, and mucous membranes. Cream is for topical use only; avoid oral, ophthalmic, and intravaginal use.
- Use moisturizer as frequently as needed from start of treatment. Avoid contact with the eyes, lips, paranasal creases, mucous membranes.
- Instruct patient on application technique. Advise patient to read Patient Information before starting therapy and with each Rx refill in case of changes.
- Inform patient that erythema, scaling, dryness, and stinging/burning may occur, with greatest severity within the first 4 weeks of therapy. Severity usually decreases with continued use of trifarotene. Instruct patient to use a moisturizer, reduce the frequency of application, or suspend use temporarily. If severe reactions persist therapy may be discontinued.
- Advise patient to avoid application to cuts, abrasions, or eczematous or sunburned skin and to avoid use of "waxing" as a depilatory method in the area treated.
- Caution patient to minimize unprotected exposure to ultraviolet rays (including sunlight and sunlamps) during therapy. Warn patients who normally experience high levels of sun exposure and those with inherent sensitivity to sun to exercise caution. Use sunscreen products and protective clothing over treated areas when exposure cannot be avoided.
- Advise patient to avoid concomitant use of other potentially irritating topical products (medicated or not).
- Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
- Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding. If breastfeeding, use cream on the smallest area of skin and for the shortest duration possible to minimize potential exposure to the breastfed infant via breast milk. Advise breastfeeding women not to apply cream directly to nipple and areola to avoid direct infant exposure.
Decreased severity of acne vulgaris.
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