Aklief Special Precautions

Skin Irritation: Patients using Trifarotene (Aklief) Cream 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. Depending upon the severity of these adverse reactions, instruct patients to use a moisturizer, reduce the frequency of application of Trifarotene (Aklief) Cream, or suspend use temporarily. If severe reactions persist the treatment may be discontinued.
Caution should be exercised if cosmetics or acne medications with desquamative, irritant or drying effects are concomitantly used with the medicinal product, as they may produce additive irritant effects.
Avoid application of Trifarotene (Aklief) to cuts, abrasions, or eczematous or sunburned skin. Use of "waxing" as a depilatory method should be avoided on skin treated with Trifarotene (Aklief) Cream.
Ultraviolet Light and Environmental Exposure: Minimize unprotected exposure to ultraviolet rays (including sunlight and sunlamps) during treatment with Trifarotene (Aklief). Warn patients who normally experience high levels of sun exposure and those with inherent sensitivity to sun to exercise caution. Use of sunscreen products and protective clothing over treated areas is recommended when exposure cannot be avoided.
Avoid contact with the eyes, lips, and mucous membranes.
If the product enters the eye, wash immediately and abundantly with lukewarm water.
This product contains propylene glycol (E1520) that may cause skin irritation.
Trifarotene (Aklief) also contains 50 mg alcohol (ethanol) in each gram which isequivalent to 5% w/w. It may cause burning sensation on damaged skin.
Use in Renally Impaired: Trifarotene (Aklief) has not been studied in patients with renal impairment.
Use in Hepatically Impaired: Trifarotene (Aklief) has not been studied in patients with hepatic impairment.
Use in Children: Safety and effectiveness of Trifarotene (Aklief) Cream for the topical treatment of acne vulgaris have been established in pediatric patients age 9 years to 17 years based on evidence from well-controlled clinical trials, a long-term safety trial, and a pharmacokinetic trial. A total of 897 pediatric subjects aged 9 to 17 years received Trifarotene (Aklief) Cream in the clinical trials.
Safety and effectiveness of Trifarotene (Aklief) Cream have not been established in pediatric subjects under the age of 9 years.
Use in the Elderly: Clinical trials of Trifarotene (Aklief) Cream did not include any subjects aged 65 years and over to determine whether they respond differently than younger subjects.