Aklief Cream
Trifarotene topical
0.05 mg/g
GALDERMA INTERNATIONAL
| Pack size | 1 Polypropylene (PP) Bottle (30 g) with a PP Pump/Overcap |
|---|---|
| Dispensing mode | POM |
| Source | FRANCE |
| Agent | Modern pharmaceutical company |
| Retail Price | 64.50 AED |
Available as:
Indications
Aklief Cream is used for:
Acne Vulgaris
Adult Dose
Acne Vulgaris
Retinoid indicated for topical treatment of acne vulgaris
Apply a thin layer of cream sparingly to affected areas qDay, in the evening, on clean, dry skin
Child Dose
Acne Vulgaris
Retinoid indicated for topical treatment of acne vulgaris in patients aged ?9 years
<9 year: Safety and efficacy not established
>9 years: Apply thin layer of cream sparingly to affected areas qDay, in the evening, on clean, dry skin
Renal Dose
Administration
Topical use only; not for oral, ophthalmic, or intravaginal use
One pump actuation should be enough to cover the face (ie, forehead, cheeks, nose, and chin)
Two actuations of the pump should be enough to cover the upper trunk (ie, reachable upper back, shoulders, and chest)
May use 1 additional pump actuation for middle and lower back if acne is present
Use of a moisturizer is recommended as frequently as needed from the start of treatment
Avoid contact with the eyes, lips, paranasal creases, and mucous membranes
Avoid application to cuts, abrasions, or eczematous or sunburned skin
Avoid use of “waxing” as a depilatory method on treated skin
Contra Indications
Precautions
Skin irritation
May experience erythema, scaling, dryness, and stinging/burning
Maximum severity of these reactions typically occurred within the first 4 weeks of treatment, and severity decreased with continued use of the medication
Advise to use a moisturizer, reduce the frequency of application, or suspend use temporarily
If severe reactions persist, consider discontinuing treatment
Minimize unprotected exposure to ultraviolet rays (including sunlight and sunlamps) during treatment; exercise caution in patients who normally experience high levels of sun exposure and those with inherent sensitivity to sun; use sunscreen products and protective clothing over treated areas when exposure cannot be avoided
Pregnancy-Lactation
Pregnancy
Available data from clinical trials with use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
There are case reports of major birth defects similar to those seen in fetuses exposed to oral retinoids in pregnant women exposed to other topical retinoids, but these reports do not establish a pattern or association with retinoid-related embryopathy
Animal data
In animal reproduction studies, oral doses of trifarotene administered to pregnant rats and rabbits during organogenesis that resulted in systemic exposures more than 800 times the systemic exposure at the maximum recommended human dose (MRHD) of topical cream resulted in adverse fetal effects, including fetal deaths and external, visceral, and skeletal malformations
Lactation
There are no data on the presence of trifarotene in human milk, the effects on the breastfed infant, or the effects on milk production
Trifarotene was present in rat milk with oral administration of the drug
When present in animal milk, it is likely that the drug will be present in human milk; topical administration of large amounts of trifarotene may result in sufficient systemic absorption to produce detectable quantities in human milk
Consider the developmental and health benefits of breastfeeding, along with the mother’s clinical need and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition
Clinical considerations
To minimize potential exposure to the breastfed infant via breastmilk, use on the smallest area of skin and for the shortest duration possible while breastfeeding
Advise breastfeeding women not to apply directly to the nipple and areola to avoid direct infant exposure
Interactions
Adverse Effects
Side effects of Trifarotene topical :
>10%
Mild dryness, face (39%)
Mild scaling, face (37.5%)
Mild stinging/burning, face (36.5%)
Mild dryness, trunk (32.9%)
Mild erythema, face (30.6%)
Moderate dryness, face (29.7%)
Mild scaling, trunk (29.7%)
Moderate erythema, face (28.4%)
Moderate scaling, face (27.1%)
Mild erythema, trunk (26.5%)
Mild stinging/burning, trunk (26.1%)
Moderate dryness, trunk (16.1%)
Moderate erythema, trunk (18.7%)
Moderate scaling, trunk (13.7%)
Moderate stinging/burning, face (20.6%)
Moderate stinging/burning, trunk (10.9%)
1-10%
Application site irritation (4.2-7.5%)
Severe erythema, face (6.2%)
Severe stinging/burning, face (5.9%)
Sunburn (2.6-5.5%)
Severe erythema, trunk (5.2%)
Severe scaling, face (4.9%)
Severe dryness, face (4.8%)
Severe scaling, trunk (4.3%)
Application site pruritus (2.4-4.6%)
Severe dryness, trunk (1.8%)
Severe scaling, trunk (1.7%)
Mechanism of Action
An agonist of retinoic acid receptors (RARs), with particular activity at the gamma subtype of RAR
Stimulation of RAR results in modulation of target genes that are associated with various processes, including cell differentiation and mediation of inflammation
Exact process by which trifarotene ameliorates acne is unknown
Note
Aklief 0.05 mg/g Cream manufactured by GALDERMA INTERNATIONAL. Its generic name is Trifarotene topical. Aklief is availble in United Arab Emirates.
Farmaco UAE drug index information on Aklief Cream is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.