Finacea Foam

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

Each gram of Finacea (azelaic acid) Foam contains 0.15 g of azelaic acid (15% w/w) in a white to off-white foam.

None.

The following adverse reactions are described elsewhere in the prescribing information:

• Hypopigmentation [seeWarnings and Precautions (5.1)]. • Eye and Mucous Membranes Irritation [seeWarnings and Precautions (5.2)].

Clinical 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*	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%)

  * “Application site pain” is a term used to describe disagreeable skin sensations, including burning, stinging, paraesthesia and tenderness.

Post-Marketing 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.

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.

Finacea (azelaic acid) Foam contains 15% (w/w) azelaic acid, a naturally-occurring saturated dicarboxylic acid and is suspended in an oil-in-water emulsion vehicle for topical administration to affected skin area. Chemically, azelaic acid is 1,7-heptanedicarboxylic acid. The structural formula of azelaic acid is:

Azelaic acid has a molecular formula of C9 H16 O4 and a molecular weight of 188.22.

The aluminum containers are filled with hydrophilic emulsion, crimped with a continuous spray valve, and pressurized with propellants consisting of propane, butane, and isobutane. Each gram of Finacea Foam contains 0.15 g of azelaic acid. Finacea Foam also contains benzoic acid, cetostearyl alcohol, dimethyl isosorbide, medium-chain triglycerides, methylcellulose, mono- and di-glycerides, polyoxyl 40 stearate, polysorbate 80, propylene glycol, purified water, sodium hydroxide, and xanthan gum as inactive ingredients.

Mechanism of Action

The mechanism(s) by which azelaic acid interferes with the pathogenic events in rosacea are unknown.

12.2 Pharmacodynamics

The efficacy of Finacea Foam is being driven by local mechanisms of azelaic acid within the skin.

12.3 Pharmacokinetics

Pharmacokinetics of azelaic acid and its metabolite pimelic acid was assessed in 21 adult subjects with moderate papulopustular rosacea with a minimum of 15 and no more than 50 inflammatory lesions (papules and/or pustules). Endogenous plasma concentrations of azelaic acid (range <1-105 ng/mL) and pimelic acid (range 0.69-27 ng/mL) were measured over various time points over 2 days prior to treatment initiation. The endogenous plasma concentrations varied widely across subjects and the mean ± SD values of endogenous azelaic acid plasma concentrations ranged between 4.5 ± 2.4 ng/mL and 14.6 ± 5.6 ng/mL and pimelic acid plasma concentrations ranged between 2.2 ± 1.1 ng/mL and 3.7 ± 3.1 ng/mL.

Following topical dermal applications of a mean dose of 0.94 g of Finacea Foam (141 mg azelaic acid) twice daily for 7 consecutive days, systemic concentrations of azelaic acid were at steady state by Day 5. On Day 7, a wide range of maximum azelaic acid (22.2 to 90.1 ng/mL) and pimelic acid (2.3-16.9 ng/mL) plasma concentrations (Cmax) was also observed after treatment with Finacea Foam. The mean ± SD Cmax for azelaic acid and pimelic acid were 51.8 ± 18.5 ng/mL and 5.0 ± 3.0 ng/mL, respectively. The mean ± SD systemic exposure of azelaic acid and pimelic acid within a dosing interval (AUC0-12h) were 442.0 ± 177.6 ng.h/mL and 43.4 ± 15.4 ng.h/mL, respectively.

Azelaic acid is mainly excreted unchanged in the urine, but undergoes some ß-oxidation to shorter chain dicarboxylic acids.

Inform patients using Finacea Foam of the following information and instructions:

• For external use only. • Cleanse affected area(s) with a very mild soap or a soapless cleansing lotion and pat dry with a soft towel. • Shake well before use. • Avoid use of alcoholic cleansers, tinctures and astringents, abrasives and peeling agents. • 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 your physician if eye irritation persists. • If allergic reactions occur, discontinue use and consult your physician. • Wash hands immediately following application of Finacea Foam. • Cosmetics may be applied after the application of Finacea Foam has dried. • Avoid the use of occlusive dressings and wrappings. • To help manage rosacea, avoid any triggers that may provoke erythema, flushing, and blushing. These triggers can include spicy and thermally hot food and drinks such as hot coffee, tea, or alcoholic beverages. • The propellant in Finacea Foam is flammable. Avoid fire, flame, or smoking during and immediately following application. • Discard product 8 weeks after opening.

© 2015, Bayer HealthCare Pharmaceuticals Inc. All rights reserved.

Manufactured for:

Bayer HealthCare Pharmaceuticals Inc.

Whippany, NJ 07981

Manufactured in Switzerland

Sample-Not For Sale

Finacea
(azelaic acid) Foam, 15%
Rx only
For Topical Use Only
Not for oral, ophthalmic or intravaginal use
30 grams
topical

Finacea Foam  azelaic acid aerosol, foam

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:50419-829 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AZELAIC ACID (AZELAIC ACID) AZELAIC ACID .15 g  in 1 g

Inactive Ingredients Ingredient Name Strength BENZOIC ACID   CETOSTEARYL ALCOHOL   DIMETHYL ISOSORBIDE   MEDIUM-CHAIN TRIGLYCERIDES   POLYOXYL 40 STEARATE   POLYSORBATE 80   PROPYLENE GLYCOL   WATER   SODIUM HYDROXIDE   XANTHAN GUM

Packaging # Item Code Package Description 1 NDC:50419-829-01 1 CAN in 1 CARTON 1 50 g in 1 CAN 2 NDC:50419-829-71 1 CAN in 1 CARTON 2 30 g in 1 CAN 3 NDC:50419-829-72 1 CAN in 1 CARTON 3 15 g in 1 CAN

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA207071 08/03/2015

Labeler - Bayer HealthCare Pharmaceuticals Inc. (005436809)

Establishment
Name	Address	ID/FEI	Operations
ASM Aerosol-Service AG		480286111	MANUFACTURE(50419-829)

Revised: 10/2016   Bayer HealthCare Pharmaceuticals Inc.