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AKLIEF is a brand name for Trifarotene, supplied as a cream. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
General For external use only. Not for ophthalmic use. AKLIEF should not be applied to cuts, abrasions, eczematous or sunburned skin. Avoid contact with the eyes, mouth, lips, angles of the nose, mucous membranes, abraded skin and open wounds.
If contact occurs, rinse thoroughly with warm water. AKLIEF should be applied only to the affected areas. Excessive use should be avoided. If a reaction suggesting allergic / hypersensitivity reactions to any component of the formulation occurs, the use of the product should be discontinued.
Concomitant topical acne therapy is not recommended because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents (see DRUG INTERACTIONS, Drug-Drug Interactions). Avoid concomitant use of dermatologic medications and potentially irritating topical products (abrasive soaps and cleansers, soaps and cosmetics) that have strong skin-drying effect and products with high concentrations of alcohol, astringents, spices, or limes.
Patients should be advised to use non-comedogenic cosmetics. Colour cosmetics such as blushes and powders are acceptable, however, make-up cosmetics should be water based only. Cosmetics must be removed by thorough cleansing before the area is treated.
The treatment area should not be covered with dressings or bandages. Weather extremes, such as wind or cold, may be more irritating to some patients using AKLIEF. Skin Local cutaneous reaction Certain cutaneous signs and symptoms such as erythema, dryness, scaling, burning or pruritus are associated with the topical application of retinoids and can also be expected with the use of AKLIEF.
Most of these treatment-related reactions are mild to moderate with few being severe (see ADVERSE REACTIONS). Maximum severity typically occurred within the first 4 weeks of treatment, and decreased with continued use of the medication.
AKLIEF was better tolerated on the trunk than on the face. To mitigate the risk of such treatment-related reactions, patients should be instructed to use a non- comedogenic moisturizer before and after application from the initiation of treatment, and if appropriate reduce the frequency of application of AKLIEF, or discontinue use temporarily until the symptoms subside.
Despite mitigation measures, if severe reactions persist the treatment may be discontinued permanently (see DOSAGE AND ADMINISTRATION). AKLIEF™ (trifarotene) Product Monograph Page 9 of 33 As with other retinoids, use of “waxing” as a depilatory method should be avoided on skin treated with AKLIEF.
Ultraviolet Light and Environmental Exposure As with any retinoid, exposure to excessive sunlight, including sunlamps, should be avoided while using the preparation, or a suitably effective sunscreen product and protective clothing over the treated areas is recommended when exposure cannot be avoided.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Patients with sunburn should be advised not to use AKLIEF until fully recovered. Patients who may have considerable sun exposure due to their occupation and those patients with inherent sensitivity to sunlight should exercise particular caution when using AKLIEF.
, thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the increased possibility of augmented photosensitivity Carcinogenesis and Mutagenesis See NON-CLINICAL TOXICOLOGY. Special Populations Pregnant Women Orally administered retinoids have been associated with congenital abnormalities.
, damaged skin barrier, excessive use) (see CONTRAINDICATIONS). There have been rare reports of birth defects among babies born to women exposed to topical retinoids during pregnancy. However, there are no adequate and well-controlled studies in pregnant women with AKLIEF; therefore the safety and efficacy of trifarotene in pregnant women has not been established (see CONTRAINDICATIONS).
If the patient believes they have become pregnant while using AKLIEF, they should discontinue treatment immediately and contact their healthcare provider. Women of child-bearing potential should be informed of the potential risk and use effective birth-control measures when AKLIEF is used.
The possibility that a woman of childbearing potential is pregnant at the time of institution of therapy should be considered. Confirmation that the patient is not pregnant should be received prior to starting treatment and before each new treatment course.
Although there may be less systemic exposure in the treatment of acne of the face and/or trunk alone due to less surface area for application, trifarotene is a teratogenic substance, and it is not known what level of exposure is required for teratogenicity in humans.
AKLIEF™ (trifarotene) Product Monograph Page 10 of 33 Studies in animals with trifarotene by the oral route have shown reproductive toxicity at high systemic exposure with safety margin based on the rat study of about 55-fold compared to the maximum recommended human dose (MRHD), while safety margins based on the rabbit study could not be established (see NON-CLINICAL TOXICOLOGY).
Due to the limited available data and considering the low cutaneous passage of trifarotene, AKLIEF should not be used during pregnancy or in women planning a pregnancy. If the product is used during pregnancy, or if the patient becomes pregnant while taking this drug, treatment should be discontinued and their healthcare provider notified immediately.
Breastfeeding Women It is unknown whether trifarotene is excreted in human milk following the use of AKLIEF. Oral animal studies have shown that trifarotene is excreted in the milk of lactating rats. In a two-generation study in rats, no relevant plasma levels were detectable in pups […]