Trifarotene
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Omid Afkhami-Ardakani
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Overview
Trifarotene is a retinoid that is FDA approved for the treatment of acne vulgaris in patients 9 years of age and older. Common adverse reactions include Application site irritation, Application site pruritus (itching), Sunburn.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Trifarotene FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Trifarotene in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Trifarotene in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Trifarotene FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Trifarotene in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Trifarotene in pediatric patients.
Contraindications
There is limited information regarding Trifarotene Contraindications in the drug label.
Warnings
Skin Irritation: Patients using trifarotene may experience erythema (redness), scaling, dryness, and stinging/burning. It is recommended to use a moisturizer from the initiation of treatment. Depending upon the severity of these adverse reactions, reduce the frequency of application, suspend, or discontinue use.
Application to Eczematous or Sunburned Skin: Avoid application to cuts, abrasions, eczematous, or sunburned skin.
Use of Depilatory Methods: Use of "waxing" as a depilatory method should be avoided on skin treated with trifarotene.
Adverse Reactions
Clinical Trials Experience
Application Site Reactions: Irritation Pruritus (itching) Erythema (redness) Scaling Dryness Stinging/burning
Other Reactions: Sunburn
Postmarketing Experience
There is limited information regarding Trifarotene Postmarketing Experience in the drug label.
Drug Interactions
Concomitant Topical Medications: Caution should be exercised when using trifarotene in combination with other topical medications, as this may increase skin irritation.
Photosensitizing Agents: Avoid concomitant use of medications known to increase sensitivity to sunlight, as this may enhance the photosensitizing effect.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Trifarotene in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Trifarotene in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Trifarotene during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Trifarotene in women who are nursing.
Pediatric Use
The safety and effectiveness of trifarotene have been established in pediatric patients aged 9 years and older.
Geriatic Use
There is no FDA guidance on the use of Trifarotene in geriatric settings.
Gender
There is no FDA guidance on the use of Trifarotene with respect to specific gender populations.
Race
There is no FDA guidance on the use of Trifarotene with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Trifarotene in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Trifarotene in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Trifarotene in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Trifarotene in patients who are immunocompromised.
Administration and Monitoring
Administration
Dosage: Apply a thin layer of trifarotene cream to the affected areas once a day, in the evening, on clean and dry skin.
Route: Topical application only.
Monitoring
Skin Irritation: Monitor for signs of erythema, scaling, dryness, and stinging/burning. Photosensitivity: Advise patients to report any signs of increased sensitivity to sunlight.
IV Compatibility
Not Applicable.
Overdosage
Trifarotene is intended for once-daily application. If excessive application occurs, it may result in significant irritation. In such cases, discontinue use and institute appropriate symptomatic treatment.
Pharmacology
There is limited information regarding Trifarotene Pharmacology in the drug label.
Mechanism of Action
Trifarotene is a retinoid that selectively targets retinoic acid receptor gamma (RAR-γ), the most prevalent retinoic acid receptor in the skin. Activation of RAR-γ modulates gene expression that leads to normalization of keratinization and has anti-inflammatory effects, thereby reducing the formation of comedones and inflammatory lesions associated with acne vulgaris.
Structure
There is limited information regarding Trifarotene Structure in the drug label.
Pharmacodynamics
The exact process by which trifarotene ameliorates acne is unknown.
Pharmacokinetics
Absorption: Trifarotene has minimal systemic absorption when applied topically. Metabolism: It is metabolized by the liver, primarily via cytochrome P450 enzymes. Elimination: The metabolites are excreted predominantly in the urine.
Nonclinical Toxicology
There is limited information regarding Trifarotene Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Trifarotene Clinical Studies in the drug label.
How Supplied
Dosage Forms and Strengths: Trifarotene is supplied as a cream with a concentration of 0.005% (50 micrograms per gram). Available in a 45-gram pump bottle.
Storage
Store at room temperature between 20°C to 25°C (68°F to 77°F). Keep the bottle tightly closed to protect from moisture. Do not freeze.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
Administration: Instruct patients to apply a thin layer of trifarotene cream to the affected areas once daily, in the evening, on clean and dry skin. Advise patients to avoid contact with the eyes, lips, paranasal creases, and mucous membranes. Recommend the use of a moisturizer from the initiation of treatment to mitigate potential skin irritation. Potential Side Effects: Inform patients about the possibility of application site reactions such as irritation, pruritus (itching), erythema (redness), scaling, dryness, and stinging/burning. Advise patients to contact their healthcare provider if they experience severe skin reactions or if irritation persists.
Photosensitivity: Advise patients to minimize exposure to sunlight and sunlamps during treatment. Recommend the use of sunscreen and protective clothing over treated areas when exposure cannot be avoided.
Storage: Instruct patients to store trifarotene cream at room temperature, away from moisture, and to keep the bottle tightly closed.
Precautions with Alcohol
Alcohol-Trifarotene interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
Trifarotene is marketed under the brand name AKLIEF.
Look-Alike Drug Names
There is limited information regarding Trifarotene Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.