FINACEA FOAM- azelaic acid aerosol, foam

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bayer HealthCare Pharmaceuticals Inc.

INN (International Name):

AZELAIC ACID

Composition:

AZELAIC ACID .15 g in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Finacea(azelaic acid) Foam, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. None. There are no adequate and well-controlled studies in pregnant women. Therefore, Finacea Foam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Dermal embryofetal developmental toxicology studies have not been performed with azelaic acid, 15% foam. 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 maximum recommended human dose (MRHD) based on body surface area (BSA)], rabbits given 150 or 500 mg/kg/day (19 or 65 times the MRHD based on BSA) and cynomolgus monkeys g

Product summary:

Finacea (azelaic acid) Foam 15% is a white to off-white emulsion supplied in a pressurized 50 g (NDC 50419-829-01) aluminum can. Store at 25◦ C (77◦ F); excursions permitted between 15–30◦ C (59–86◦ F) [See USP Controlled Room Temperature]. WARNING:Flammable. Avoid fire, flame, or smoking during and immediately following application. Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperatures above 120°F (49°C).

Authorization status:

New Drug Application

Summary of Product characteristics

FINACEA FOAM- AZELAIC ACID AEROSOL, FOAM
BAYER HEALTHCARE PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FINACEA FOAM SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR FINACEA FOAM.
FINACEA® (AZELAIC ACID) FOAM, 15% FOR TOPICAL USE
INITIAL U.S. APPROVAL: 2015
INDICATIONS AND USAGE
Finacea Foam is indicated for the topical treatment of inflammatory
papules and pustules of mild to moderate rosacea. (1)
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
Foam, 15% (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
•
•
•
ADVERSE REACTIONS
In clinical studies, the most frequently observed adverse reactions in
≥ 0.5% of subjects treated with Finacea Foam
included local site pain (6.2%), pruritus (2.5%), dryness (0.7%), and
erythema (0.7%). (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BAYER HEALTHCARE AT
1-866-463-3634 OR FDA AT 1-800-
FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 7/2019
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 Reactions
5.2 Eye and Mucous Membranes Irritation
5.3 Flammability
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Post-Marketing Experience
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
Apply a thin layer of Finacea Foam twice daily (morning and evening)
to the entire facial area (cheeks, chin, forehead,
and nose). (2)
Cosmetics may be applied after the application of Finacea Foam has
dried. (2)
Isolated cases of hypopigmentation occurred after azelaic acid use.
(5.1)
Azelaic acid has been reported to cause irritation of the eyes.
Therefore, avoid contact with the eyes and mucous
membranes. (5.2)
Contents are flammable. Instruct the patient to avoid fire, flame, and
smoking during and immediately following
application. (5.3)
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCR