AKLIEF Cream (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Galderma Laboratories, L.P.

Λέξεις κλειδιά

0299-5935

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1. Indications and Usage

AKLIEF Cream is a retinoid indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.

2. Dosage 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). ...

3. Dosage Forms and Strengths

Cream: 0.005%. Each gram of AKLIEF Cream contains 50 mcg of trifarotene in a white cream.

4. Contraindications

None.

5. Warnings and Precautions

5.1 Skin Irritation Patients using AKLIEF Cream may experience erythema, scaling, dryness, and stinging/burning. Maximum severity of these reactions typically occurred within the first 4 weeks of treatment, ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of ...

7. Drug Interactions

Topical application of AKLIEF Cream is not expected to affect the circulating concentrations of oral hormonal contraceptives containing ethinyl estradiol and levonorgestrel.

8.1. Pregnancy

Risk Summary Available data from clinical trials with AKLIEF Cream use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. ...

8.2. Lactation

Risk Summary There are no data on the presence of trifarotene in human milk, the effects on the breastfed infant, or the effects on milk production. In animal studies, trifarotene was present in rat milk ...

8.4. Pediatric Use

Safety and effectiveness of 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, ...

8.5. Geriatric Use

Clinical trials of AKLIEF Cream did not include any subjects aged 65 years and over to determine whether they respond differently than younger subjects.

11. Description

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- ...

12.1. Mechanism of Action

Trifarotene is an agonist of retinoic acid receptors (RAR), with particular activity at the gamma subtype of RAR. Stimulation of RAR results in modulation of target genes which are associated with various ...

12.2. Pharmacodynamics

At the approved recommended dosage, AKLIEF Cream does not prolong the QT interval to any clinically relevant extent.

12.3. Pharmacokinetics

Pharmacokinetics of trifarotene was evaluated in a study involving 19 adult subjects with acne vulgaris following once daily application of AKLIEF Cream for 29 days (daily dose range 1.5 g/day to 2 g/day) ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Trifarotene was not carcinogenic when topically applied to mice daily for up to 24 months in the vehicle of the product (AKLIEF Cream) at concentrations of 0.0005% or 0.001% w/w. The systemic exposures ...

14. Clinical 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 ...

16.1. How Supplied

AKLIEF Cream, 0.005% is provided as a white cream supplied in the following packaging configurations with corresponding NDC numbers: 30-gram pump NDC 0299-5935-30 45-gram pump NDC 0299-5935-45 75-gram ...

16.2. Storage and Handling

Store at 20 to 25˚C (68 to 77˚F) with excursions permitted to 15°to 30°C (59° to 86°F). Keep away from heat. Keep out of reach of children.

17. Patient 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 ...