FINACEA- azelaic acid gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AZELAIC ACID (UNII: F2VW3D43YT) (AZELAIC ACID - UNII:F2VW3D43YT)

Available from:

LEO Pharma Inc.

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

FINACEA Gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. Limitations of Use Although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated. None. Risk Summary Azelaic acid is minimally absorbed systemically following topical route of administration, and maternal use is not expected to result in fetal exposure to the drug [see Clinical Pharmacology (12.3)]. In animal reproduction studies, embryofetal toxicity was noted when azelaic acid was administered orally during the period of organogenesis at doses 162, 19, and 65 times the maximum recommended human dose (MRHD) in rats, rabbits, and monkeys, respectively. Maternal toxicity was noted at these doses but no malformations were observed in these embryofetal developmental studies (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 U.S. 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 Dermal embryofetal developmental toxicology studies have not been performed with azelaic acid, 15% gel. Oral embryofetal developmental studies were conducted with azelaic acid in rats, rabbits, and cynomolgus monkeys. Azelaic acid was administered during the period of organogenesis in all three animal species. Embryotoxicity was observed in rats, rabbits, and monkeys at oral doses of azelaic acid that generated some maternal toxicity. Embryotoxicity was observed in rats given 2500 mg/kg/day [162 times the MRHD based on body surface area (BSA) comparison], rabbits given 150 or 500 mg/kg/day (19 or 65 times the MRHD based on BSA comparison) and cynomolgus monkeys given 500 mg/kg/day (65 times the MRHD based on BSA comparison) azelaic acid. No malformations were observed in the oral embryofetal developmental studies conducted in rats, rabbits and cynomolgus monkeys. An oral peri- and post-natal developmental study was conducted in rats. Azelaic acid was administered from gestational day 15 through day 21 postpartum up to a dose level of 2500 mg/kg/day. Embryotoxicity was observed in rats at an oral dose of 2500 mg/kg/day (162 times the MRHD based on BSA comparison) that generated some maternal toxicity. In addition, slight disturbances in the post-natal development of fetuses was noted in rats at oral doses that generated some maternal toxicity (500 and 2500 mg/kg/day; 32 and 162 times the MRHD based on BSA comparison). No effects on sexual maturation of the fetuses were noted in this study. Risk Summary Azelaic acid is naturally present in human milk. When used as prescribed, azelaic acid is unlikely to be absorbed through the skin in clinically relevant amounts to cause a change in azelaic acid concentration in milk or milk production; therefore, breastfeeding is not expected to result in exposure of the infant to FINACEA Gel. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for FINACEA Gel and any potential adverse effects on the breastfed child from FINACEA Gel or from the underlying maternal condition. The safety and effectiveness of FINACEA Gel have not been established in pediatric patients. Clinical studies of FINACEA Gel did not include sufficient numbers of subjects aged 65 and over to determine if they respond differently than younger subjects.

Product summary:

How Supplied FINACEA (azelaic acid) Gel, 15% is a white to yellowish white opaque gel supplied in a 50 g tube (NDC 50222-505-50). Storage and Handling Store at 25°C (77°F); excursions permitted between 15–30°C (59–86°F) [see USP Controlled Room Temperature] .

Authorization status:

New Drug Application

Summary of Product characteristics

FINACEA- AZELAIC ACID GEL
LEO PHARMA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FINACEA GEL SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FINACEA GEL.
FINACEA (AZELAIC ACID) GEL, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1995
INDICATIONS AND USAGE
FINACEA (azelaic acid) Gel, 15% is indicated for topical treatment of
the inflammatory papules and
pustules of mild to moderate rosacea (1).
Limitations of Use
Efficacy for treatment of erythema in rosacea in the absence of
papules and pustules has not been
evaluated. (1)
DOSAGE AND ADMINISTRATION
Apply a thin layer twice daily to affected area(s). (2)
Use only very mild soaps or soapless cleansing lotion and pat dry with
a soft towel before applying
FINACEA Gel. (2)
Wash hands immediately following application. (2)
Cosmetics may be applied after the application of FINACEA Gel has
dried. (2)
Avoid use of alcoholic cleansers, tinctures and astringents, abrasives
and peeling agents. (2)
For topical use. (2)
Not for oral, ophthalmic or intravaginal use. (2)
DOSAGE FORMS AND STRENGTHS
Gel, 15% (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
_Hypersensitivity_: Hypersensitivity reactions, including cases of
angioedema, eye swelling, facial
swelling, dyspnea, urticaria, and adverse skin reactions, have been
reported. In case of known
hypersensitivity to any component of the gel, avoid the use of FINACEA
Gel. If hypersensitivity develops,
discontinue treatment and institute appropriate therapy. (5.1)
_Skin Reactions:_ Skin irritation (i.e. pruritus, burning or stinging)
may occur, usually during the first few
weeks of treatment. If sensitivity or severe irritation develops and
persists, discontinue treatment and
institute appropriate therapy. (5.2)
_Hypopigmentation:_ Isolated cases of hypopigmentation occurred after
azelaic acid use. Monitor
patients with dark complexion for early signs of hypopigmentation
(5.2)
_Eye and Mucous Membrane Irritation:_ FINACEA Gel has been reported