Brand Name
Aklief
Generic Name
Trifarotene
View Brand Information FDA approval date: October 04, 2019
Classification: Retinoid
Form: Cream
What is Aklief (Trifarotene)?
AKLIEF Cream is a retinoid indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. AKLIEF Cream is a retinoid indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.
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Brand Information
AKLIEF (trifarotene)
1INDICATIONS AND USAGE
AKLIEF Cream is a retinoid indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.
2DOSAGE AND 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.
3DOSAGE FORMS AND STRENGTHS
Cream: 0.005%. Each gram of AKLIEF Cream contains 50 mcg of trifarotene in a white cream.
4CONTRAINDICATIONS
None
5DRUG INTERACTIONS
Topical application of AKLIEF Cream is not expected to affect the circulating concentrations of oral hormonal contraceptives containing ethinyl estradiol and levonorgestrel.
6DESCRIPTION
AKLIEF Cream for topical administration contains 0.005% (50 mcg/g) trifarotene. Trifarotene is a terphenyl acid derivative and is a retinoid. The chemical name of trifarotene is 3”-tert-Butyl-4’-(2-hydroxy-ethoxy)-4”-pyrrolidin-1-yl-[1,1’,3’,1”]terphenyl-4- carboxylic acid. Trifarotene has the molecular formula of C
Trifarotene is a white to off-white to slightly yellow powder with the melting point of 245°C. It is practically insoluble in water with pKa1 of 5.69 and pKa2 of 4.55.
7CLINICAL STUDIES
AKLIEF Cream applied once daily in the evening was evaluated in the treatment of moderate facial and truncal acne vulgaris in two randomized, multicenter, parallel group, double-blind, vehicle-controlled trials of identical design, Study 1 (NCT02566369) and Study 2 (NCT02556788). The trials were conducted in a total of 2420 subjects aged 9 years and older, who were treated for up to 12 weeks with either AKLIEF Cream (1214 subjects) or vehicle cream (1206 subjects). Subjects were encouraged to use a moisturizer as desired, while allowing an interval of approximately 1 hour before or after the study treatment application.
8HOW SUPPLIED/STORAGE AND HANDLING
AKLIEF Cream, 0.005% is provided as a white cream supplied in the following packaging configurations with corresponding NDC numbers:
- 45-gram pump NDC 0299-5935-45
Storage and Handling
- Store at 20˚ to 25˚C (68˚ to 77˚F); excursions permitted to 15° to 30°C (59° to 86°F)..
- Keep away from heat.
- Keep out of reach of children.
- Store at 20˚ to 25˚C (68˚ to 77˚F); excursions permitted to 15° to 30°C (59° to 86°F)..
- Keep away from heat.
- Keep out of reach of children.
9PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (Patient Information).
Advise the patient to:
- Cleanse the area to be treated; pat dry. Apply AKLIEF Cream as a thin layer once daily in the evening to the face, avoiding the eyes, lips, nasolabial folds, and mucous membranes. A thin layer of AKLIEF Cream may also be applied to the chest, shoulders, and back.
- Avoid applying AKLIEF Cream to damaged skin (such as cuts, abrasions), eczematous areas, and sunburned skin.
- Reduce the risk of such irritation, use a moisturizer from the start of treatment, and, if appropriate, reduce the frequency of application of AKLIEF Cream or suspend use temporarily. AKLIEF Cream may cause irritation such as erythema, scaling, dryness, and stinging or burning.
- Minimize exposure to sunlight, including sunlamps and phototherapy devices.
- Use sunscreen products and protective apparel (e.g., hat) over treated areas when exposure to sunlight cannot be avoided.
- Avoid concomitant use of other potentially irritating topical products (medicated or not).
- Use AKLIEF Cream on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply AKLIEF Cream directly to the nipple and areola to avoid direct infant exposure.
Marketed by:
Patient Information
Important:AKLIEF Cream is for use on the skin only. Do not use AKLIEF Cream in your mouth eyes, or vagina.
What is AKLIEF Cream? AKLIEF Cream is a prescription medicine used on the skin (topical) to treat acne vulgaris in people 9 years of age and older.
It is not known if AKLIEF Cream is safe and effective in children younger than 9 years old.
It is not known if AKLIEF Cream is safe and effective in children younger than 9 years old.
Before using AKLIEF Cream, tell your healthcare provider about all of your medical conditions, including if you :
- have skin problems, including eczema, cuts or sunburn
- are pregnant or planning to become pregnant. It is not known if AKLIEF Cream can harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if AKLIEF Cream passes into your breast milk. Breastfeeding women should use AKLIEF Cream on the smallest area of skin and for the shortest time needed while breastfeeding.
Tell your healthcare provider about all the medicines you take,including prescription and over-the-couter medicines, vitamins and herbal supplements.
Especially tell your healthcare provider if you use any other medicine for acne.
Especially tell your healthcare provider if you use any other medicine for acne.
How should I use AKLIEF Cream?
- Use AKLIEF Cream exactly as your healthcare provider tell you to use it. Apply a thin layer of AKLIEF Cream over the affected areas 1 time each day, in the evening.
Applying AKLIEF Cream:
Wash the area where the cream will be applied and pat dry. - If you receive a sample tube of AKLIEF Cream, follow your healthcare provider’s instructions about how much to apply.
- AKLIEF Cream comes in a pump.
- When you begin treatment with AKLIEF Cream, you should begin applying a moisturizer on your skin as often as needed.
What should I avoid while using AKLIEF Cream?
- Minimize exposure to sunlight. You should avoid using sunlamps, tanning beds, and ultraviolet light during treatment with AKLIEF Cream. If you have to be in sunlight or are sensitive to sunlight, use a sunscreen with a SPF (sun protection factor) of 15 or more, and wear protective clothing and a wide-brimmed hat to cover the treated areas.
- Avoid using AKLIEF Cream on skin areas with cuts, abrasions, eczema, or on sunburned skin.
- Avoid using skin products that may dry or irritate your skin, such as:
- Avoid the use of “waxing” as a hair removal method on skin treated with AKLIEF Cream.
What are the possible side effects of AKLIEF Cream? AKLIEF Cream may cause serious side effects including:
- Local skin irritation.Local skin reactions are common with AKLIEF Cream, are most likely to happen during the first 4 weeks of treatment and may decrease with continued use of AKLIEF Cream. Signs and symptoms of local skin reactions include:
- redness
- scaling
- dryness
- stinging or burning
To help reduce your risk of developing these local skin reactions, when you begin treatment with AKLIEF Cream, you should begin applying a moisturizer on your skin as often as needed.
The most common side effects of AKLIEF Cream include: itching and sunburn.
How should I store AKLIEF Cream?
- Store AKLIEF Cream at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F)
- Keep AKLIEF Cream away from heat.
- If you receive a sample tube of AKLIEF Cream from your healthcare provider, keep the tube tightly closed.
Keep AKLIEF Cream and all medicines out of the reach of children.
General information about the safe and effective use of AKLIEF Cream. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use AKLIEF Cream for a condition for which it was not prescribed. Do not give AKLIEF Cream to other people, even if they have the same symptoms you have. It may harm them.
You can ask your pharmacist or healthcare provider for information about AKLIEF Cream that is written for health professionals.
You can ask your pharmacist or healthcare provider for information about AKLIEF Cream that is written for health professionals.
What are the ingredients in AKLIEF Cream? Active ingredient: trifarotene
Inactive ingredients:allantoin, copolymer of acrylamide and sodium acryloyldimethyltaurate dispersion 40% in isohexadecane, cyclomethicone, 95% (v/v) ethanol, medium-chain triglycerides, phenoxyethanol, propylene glycol, purified water.
Marketed by: GALDERMA LABORATORIES, L.P., Dallas, Texas 75201 USA
All trademarks are the property of their respective owners.
Made in Canada
This Patient Information has been approved by the U.S. Food and Drug Administration.
Revised: 10/2023
P54485-3
Inactive ingredients:allantoin, copolymer of acrylamide and sodium acryloyldimethyltaurate dispersion 40% in isohexadecane, cyclomethicone, 95% (v/v) ethanol, medium-chain triglycerides, phenoxyethanol, propylene glycol, purified water.
Marketed by: GALDERMA LABORATORIES, L.P., Dallas, Texas 75201 USA
All trademarks are the property of their respective owners.
Made in Canada
This Patient Information has been approved by the U.S. Food and Drug Administration.
Revised: 10/2023
P54485-3
10PACKAGE LABEL 45g CARTON
RX only
AKLIEF
(trifarotene)
Cream, 0.005%
PUMP
For topical use only
NET WT.
45 g
GALDERMA
AKLIEF
(trifarotene)
Cream, 0.005%
PUMP
For topical use only
NET WT.
45 g
GALDERMA
For topical use only Not for oral, ophthalmic or intravaginal use
USUAL DOSAGE:
Apply a thin layer to affected areas of the face and / or trunk once a day. See package insert for complete prescribing information.
EACH GRAM CONTAINS:
Active:trifarotene 0.005%
Inactive:allantoin, copolymer of acrylamide and sodium acryloyldimethyltaurate dispersion 40% in isohexadecane, cyclomethicone, 95% (v/v) ethanol, medium-chain triglycerides, phenoxyethanol, propylene glycol, purified water. Contains 5% alcohol
STORAGE:
Store at 20º to 25ºC (68º to 77ºF); excursions permitted between 15º and 30ºC (59º to 86ºF). See carton closure for lot number and expiration.
USUAL DOSAGE:
Apply a thin layer to affected areas of the face and / or trunk once a day. See package insert for complete prescribing information.
EACH GRAM CONTAINS:
Active:trifarotene 0.005%
Inactive:allantoin, copolymer of acrylamide and sodium acryloyldimethyltaurate dispersion 40% in isohexadecane, cyclomethicone, 95% (v/v) ethanol, medium-chain triglycerides, phenoxyethanol, propylene glycol, purified water. Contains 5% alcohol
STORAGE:
Store at 20º to 25ºC (68º to 77ºF); excursions permitted between 15º and 30ºC (59º to 86ºF). See carton closure for lot number and expiration.
Marketed by: