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
AgentModern 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.

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