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:

LEO Pharma Inc.

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

FINACEA Foam, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. 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 miscarria

Product summary:

How Supplied FINACEA (azelaic acid) Foam 15% is a white to off-white emulsion supplied in a pressurized 50 g (NDC 50222-303-50) aluminum can. Storage and Handling Store at 25◦ C (77◦ F); excursions permitted between 15–30◦ C (59–86◦ F) [See USP Controlled Room Temperature]. 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
LEO PHARMA 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, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1995
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
Apply a thin layer twice daily (morning and evening) to the entire
facial area (cheeks, chin, forehead, and nose). (2)
Use only very mild soaps or soapless cleansing lotion and pat dry with
a soft towel before applying FINACEA Foam. (2)
Wash hands immediately following application. (2)
Cosmetics may be applied after the application of FINACEA Foam 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
Foam, 15% (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
_Hypopigmentation:_ Isolated cases of hypopigmentation occurred after
azelaic acid use. Monitor patients with dark
complexion for early signs of hypopigmentation (5.1)
_Eye and Mucous Membrane Irritation:_ Azelaic acid has been reported
to cause irritation of the eyes. Avoid contact with
the eyes and mucous membranes. (5.2)
_Flammability:_ Contents are flammable. Instruct the patient to avoid
fire, flame, and smoking during and immediately
following application. (5.3)
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥ 0.5% of subjects
treated with FINACEA Foam) are local site pain
(6.2%), pruritus (2.5%), dryness (0.7%), and erythema (0.7%). (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT LEO PHARMA INC. AT
1-877-494-4536 OR FDA AT 1-800-
FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 12/2020
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AN