Trifarotene

What is Trifarotene?

• Trifarotene (AKLIEF) Cream is a retinoid used for the topical treatment of acne vulgaris.

What are the uses of this medicine?

• AKLIEF Cream is a retinoid indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.

How does this medicine work?

• Trifarotene is an agonist of retinoic acid receptors (RAR), with particular activity at the gamma subtype of RAR.
• Stimulation of RAR results in modulation of target genes which are associated with various processes, including cell differentiation and mediation of inflammation.
• The exact process by which trifarotene ameliorates acne is unknown.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• AKLIEF Cream is not expected to affect the circulating concentrations of oral hormonal contraceptives containing ethinyl estradiol and levonorgestrel.

Is this medicine FDA approved?

• It was approved for use in the United States in 2019.

How should this medicine be used?

Administration

• Apply a thin layer of AKLIEF Cream to the affected areas once daily, in the evening, on clean and dry skin.
• One pump actuation should be enough to cover the face (i.e., forehead, cheeks, nose, and chin).
• Two actuations of the pump should be enough to cover the upper trunk (i.e., reachable upper back, shoulders and chest). One additional pump actuation may be used for middle and lower back if acne is present.
• The use of a moisturizer is recommended as frequently as needed from the initiation of treatment.
• Avoid contact with the eyes, lips, paranasal creases, mucous membranes.
• AKLIEF Cream is for topical use only. Not for oral, ophthalmic, or intravaginal use.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Cream: 0.005% trifarotene

This medicine is available in fallowing brand namesː

• AKLIEF

What side effects can this medication cause?

The most common side effects of this medicine include:

• site irritation
• application site pruritus
• sunburn

= What special precautions should I follow?

• Patients using AKLIEF Cream may experience erythema, scaling, dryness, and stinging/burning.
• Use a moisturizer from the initiation of treatment, and, if appropriate, reduce the frequency of application of AKLIEF Cream, suspend or discontinue use.
• Avoid application of AKLIEF Cream to cuts, abrasions, or eczematous or sunburned skin. Use of “waxing” as a depilatory method should be avoided on skin treated with AKLIEF Cream.
• Minimize unprotected exposure to ultraviolet rays (including sunlight and sunlamps) during treatment with AKLIEF Cream. Use sunscreen and protective clothing over treated areas when exposure cannot be avoided.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Available data from clinical trials with AKLIEF Cream use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.

Can this medicine be used in children?

• Safety and effectiveness of AKLIEF Cream for the topical treatment of acne vulgaris have been established in pediatric patients age 9 years to 17 years.
• Safety and effectiveness of AKLIEF Cream have not been established in pediatric subjects under the age of 9 years.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• Trifarotene

Inactive ingredients:

• Allantoin
• Acrylic Acid/Sodium Acrylate Copolymer
• Isohexadecane
• Cyclomethicone 5
• Alcohol
• Medium-Chain Triglycerides
• Phenoxyethanol
• Propylene Glycol
• Water

Who manufactures and distributes this medicine?

• Packager: Galderma Laboratories, L.P.

What should I know about storage and disposal of this medication?

• Store at 20 to 25˚C (68 to 77˚F) with excursions permitted to 15°to 30°C (59° to 86°F).
• Keep away from heat.
• Keep out of reach of children.

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