FDA

Finacea

Approved 29 Jul 2015TopicalAerosol, foam

The FDA lists this product in 2 strengths and forms.

Indications

FINACEA Foam, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. FINACEA Foam is indicated for the topical treatment of inflammatory papules and pustules of mild to moderate rosacea. ( 1 )

Contraindications

None. 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 )

5.1Hypopigmentation

There have been reports of hypopigmentation after use of azelaic acid. Because azelaic acid has not been well studied in patients with dark complexion, monitor these patients for early signs of hypopigmentation.

5.2Eye and Mucous Membranes Irritation

Azelaic acid has been reported to cause irritation of the eyes. Avoid contact with the eyes, mouth and other mucous membranes. If FINACEA Foam does come in contact with the eyes, wash the eyes with large amounts of water and consult a physician if eye irritation persists.

5.3Flammability

The propellant in FINACEA Foam is flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application. Do not puncture and/or incinerate the containers. Do not expose containers to heat and/or store at temperatures above 120°F (49°C).

Pregnancy and breastfeeding

8.1Pregnancy 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.

At a glance

Brand name: Finacea
Active substance: azelaic acid
Route: Topical
Dosage form: Aerosol, foam
Applicant: Leo Pharma As
Status: Prescription
FDA approval: 29 Jul 2015
Application: NDA207071-001

Warnings and precautions

( 5.3 )

5.1Hypopigmentation

5.2Eye and Mucous Membranes Irritation

5.3Flammability

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

The following adverse reactions are described elsewhere in the prescribing information: Hypopigmentation [see Warnings and Precautions (5.1) ]. Eye and Mucous Membranes Irritation [see Warnings and Precautions (5.2) ]. 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.

6.1Clinical 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 to rates in the clinical trials of another drug and may not reflect the rates observed in practice. FINACEA Foam was evaluated for the treatment of papulopustular rosacea in two multicenter, randomized, double-blind, vehicle-controlled, 12-week clinical trials involving a total of 1362 (FINACEA Foam, 15%: 681; vehicle: 681) subjects.

Overall, 95.7% of subjects were White, 73.4% were female, and the mean age was 50.6 years. Table 1: Adverse Reactions Occurring in ≥ 0.5% of Subjects Treated with FINACEA Foam Compared with Subjects Treated with Vehicle System/Organ Class Preferred FINACEA Foam, 15% (N=681) n (%) Vehicle (N=681) n (%) General disorders and application site conditions Application site pain "Application site pain" is a term used to describe disagreeable skin sensations, including burning, stinging, paraesthesia and tenderness. 42 (6.2%) 10 (1.5%) Application site pruritus 17 (2.5%) 2 (0.3%) Application site dryness 5 (0.7%) 5 (0.7%) Application site erythema 5 (0.7%) 6 (0.9%) Local Tolerability Studies In a 21-day cumulative irritation study under occlusive conditions, mild-to-moderate irritation was observed for azelaic acid pre-foam emulsion.

In a human repeat insult patch test (HRIPT) study, no sensitization potential was observed for azelaic acid pre-foam emulsion.

6.2Postmarketing Experience

Hypersensitivity, rash and worsening of asthma have been reported from the postmarketing experience of azelaic acid-containing formulations. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Finacea

Indications

Contraindications

Warnings and precautions

5.1Hypopigmentation

5.2Eye and Mucous Membranes Irritation

5.3Flammability

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

At a glance

Two medicines in one question?

Finacea

Indications

Contraindications

Warnings and precautions

5.1Hypopigmentation

5.2Eye and Mucous Membranes Irritation

5.3Flammability

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

At a glance

Two medicines in one question?

Adverse reactions

6.1Clinical Trials Experience

6.2Postmarketing Experience

Composition

Strengths and forms

Official product information