Finacea

Finacea is a prescription medication used to treat rosacea. It clears the bumps, lesions, and swelling caused by rosacea.

Finacea belongs to a group of drugs called carboxylic acids, which work by killing the bacteria that infect pores and by decreasing the production of keratin.

This medication comes in gel form and is usually applied to the skin two times a day. 

Common side effects of Finacea include itching, burning, stinging, and tingling of the skin.

• Bayer Healthcare Pharmaceuticals Inc.

No Finacea drug interactions have been identified. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

If you use too much Finacea, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Finacea is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

You should not use this medication if you are allergic to azelaic acid or propylene glycol.

Azelaic acid topical is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether azelaic acid topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Apply the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Hypersensitivity

Hypersensitivity reactions, including cases of angioedema, eye swelling, facial swelling, dyspnea, urticaria, and adverse skin reactions, have been reported during post marketing surveillance.

Avoid the use of Finacea Gel in patients with known hypersensitivity to any component of the gel. If hypersensitivity develops during treatment, discontinue Finacea Gel and institute appropriate therapy.

Skin Reactions

Skin irritation (i.e. pruritus, burning or stinging) may occur during use of Finacea Gel, usually during the first few weeks of treatment. If sensitivity or severe irritation develops and persists, discontinue treatment and institute appropriate therapy.

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

Eye and Mucous Membranes Irritation

Avoid contact with the eyes, mouth and other mucous membranes. If Finacea Gel does come in contact with the eyes, wash the eyes with large amounts of water and consult a physician if eye irritation persists [see Adverse Reactions (6.2)].

Exacerbation of Asthma

Worsening of asthma has been reported in patients using azelaic acid formulations including Finacea Gel. Consult a physician if asthma is exacerbated with use of Finacea Gel.

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.

In two vehicle-controlled and one active-controlled U.S. clinical trials, treatment safety was monitored in 788 subjects who used twice-daily Finacea Gel for 12 weeks (N=333) or 15 weeks (N=124), or the gel vehicle (N=331) for 12 weeks. In all three trials, the most common treatment-related adverse events were: burning/stinging/tingling (29%), pruritus (11%), scaling/dry skin/xerosis (8%) and erythema/irritation (4%). In the active-controlled trial, overall adverse reactions (including burning, stinging/tingling, dryness/tightness/scaling, itching, and erythema/irritation/redness) were 19.4% (24/124) for Finacea Gel compared to 7.1% (9/127) for the active comparator gel at 15 weeks.

In patients using azelaic acid formulations, the following adverse events have been reported: worsening of asthma, vitiligo, depigmentation, small depigmented spots, hypertrichosis, reddening (signs of keratosis pilaris) and exacerbation of recurrent herpes labialis.

Finacea Gel and its vehicle caused irritant reactions at the application site in human dermal safety studies. Finacea Gel caused significantly more irritation than its vehicle in a cumulative irritation study. Some improvement in irritation was demonstrated over the course of the clinical trials, but this improvement might be attributed to subject dropouts. No phototoxicity or photoallergenicity were reported in human dermal safety studies.

Post-Marketing Experience

The following adverse reactions have been identified post approval of Finacea Gel. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure:

Eyes: iridocyclitis upon accidental exposure of the eyes to Finacea Gel

Hypersensitivity: angioedema, eye swelling, facial swelling, urticaria.

Respiratory: worsening of asthma, dyspnea, wheezing,

Finacea (azelaic acid) Gel, 15%, is an aqueous gel which contains azelaic acid, a naturally-occurring saturated dicarboxylic acid. Chemically, azelaic acid is 1,7-heptanedicarboxylic acid. The molecular formula for azelaic acid is C9 H16 O4. It has the following structure:

Azelaic acid has a molecular weight of 188.22. It is a white, odorless crystalline solid. It is poorly soluble in water at 20°C (0.24%) but freely soluble in boiling water and in ethanol.

Finacea Gel is a white to yellowish white opaque gel for topical use; each gram contains 0.15 gm azelaic acid (15%w/w) in an aqueous gel base containing benzoic acid (as a preservative), disodium EDTA, lecithin, medium-chain triglycerides, polyacrylic acid, polysorbate 80, propylene glycol, purified water, and sodium hydroxide to adjust pH.

NDC 50419-825-02

For Dermatologic Use Only
Not For Ophthalmic Use

Finacea®
(azelaic acid) Gel 15%

50 grams