AKLIEF- trifarotene cream

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

Trifarotene (UNII: 0J8RN2W0HK) (Trifarotene - UNII:0J8RN2W0HK)

Disponible depuis:

Galderma Laboratories, L.P.

Mode d'administration:

TOPICAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

AKLIEF Cream is a retinoid indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. None 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. 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 case reports do not establish a pattern or association with retinoid-related embryopathy. 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 AKLIEF Cream resulted in adverse fetal effects, including fetal deaths and external, visceral, and skeletal malformations (see Data) . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.   Data Animal Data Oral administration of trifarotene to pregnant rats during the period of organogenesis at doses that resulted in systemic exposures greater than 1600 times those in humans at the MRHD of AKLIEF Cream resulted in adverse fetal effects, including fetal deaths, reduced mean fetal weight, and external, visceral, and skeletal malformations. Oral administration of trifarotene to pregnant rabbits during the period of organogenesis at doses that resulted in systemic exposures at least 800 times those in humans at the MRHD of AKLIEF Cream resulted in adverse fetal effects, including defects of the tail, limbs, urogenital organs, and vertebral column. Trifarotene administered orally to female rats from gestation Day 6 to lactation Day 20, at doses that resulted in systemic exposures up to 594 times those in humans at the MRHD of AKLIEF Cream, had no effect on maternal function or behavior, including gestation, delivery, pup-rearing, lactation and nursing, or survival or development of pups. There were no effects of maternal treatment on behavior, learning, memory, or reproductive function of pups. 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 with oral administration of the drug. When a drug is present in animal milk, it is likely that the drug will be present in human milk. It is possible that topical administration of large amounts of trifarotene could result in sufficient systemic absorption to produce detectable quantities in human milk (see Clinical Considerations) . The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for AKLIEF Cream and any potential adverse effects on the breastfed infant from AKLIEF Cream or from the underlying maternal condition. Clinical Considerations To minimize potential exposure to the breastfed infant via breastmilk, use AKLIEF Cream on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply AKLIEF Cream directly to the nipple and areola to avoid direct infant exposure. 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, a long-term safety trial, and a pharmacokinetic trial. A total of 897 pediatric subjects aged 9 to 17 years received AKLIEF Cream in the clinical trials [see Clinical Pharmacology (12.3) and Clinical Studies (14)] . Safety and effectiveness of AKLIEF Cream have not been established in pediatric subjects under the age of 9 years. Clinical trials of AKLIEF Cream did not include any subjects aged 65 years and over to determine whether they respond differently than younger subjects.

Descriptif du produit:

AKLIEF Cream, 0.005% is provided as a white cream supplied in the following packaging configurations with corresponding NDC numbers: Storage and Handling - Store at 20˚ to 25˚C (68˚ to 77˚F); excursions permitted to 15° to 30°C (59° to 86°F).. - Keep away from heat. - Keep out of reach of children. 

Statut de autorisation:

New Drug Application

Résumé des caractéristiques du produit

AKLIEF- TRIFAROTENE CREAM
GALDERMA LABORATORIES, L.P.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AKLIEF CREAM SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AKLIEF CREAM.
AKLIEF(TRIFAROTENE) CREAM, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 2019
INDICATIONS AND USAGE
AKLIEF Cream is a retinoid indicated for the topical treatment of acne
vulgaris in patients 9 years of age
and older. (1)
DOSAGE AND ADMINISTRATION
For topical use only. Not for oral, ophthalmic or intravaginal use.
Apply a thin layer of AKLIEF Cream to the affected areas of the face
and/or trunk once a day, in the
evening, on clean and dry skin. Avoid contact with the eyes, lips,
paranasal creases, and mucous
membranes. (2)
DOSAGE FORMS AND STRENGTHS
Cream: 0.005% trifarotene. (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Skin irritation: Erythema, scaling, dryness, and stinging/burning may
be experienced with use of AKLIEF
Cream. Use a moisturizer from the initiation of treatment, and, if
appropriate, reduce the frequency of
application of AKLIEF Cream, suspend or discontinue use. (5.1)
Ultraviolet Light and Environmental Exposure: Minimize exposure to
sunlight and sunlamps. Use
sunscreen and protective clothing over treated areas when exposure
cannot be avoided. (5.2)
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥ 1%) in patients treated
with AKLIEF Cream were application
site irritation, application site pruritus, and sunburn (6).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GALDERMA LABORATORIES,
L.P. AT 1-866-
735-4137 OR FDA AT
1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH_._ _
_ _
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 10/2023
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Skin Irritation
5.2 Ultraviolet Light and Environmental Exposure
6 ADVERSE REACTIONS
6.1 Clinical tr