Azelaic acid (Finacea)

1. Health Canada Product Monograph — Azelaic acid

• Azelaic acid gel is used to treat the inflammatory papules and pustules of mild to moderate rosacea.
• Azelaic acid gel is also used to treat the facial redness (erythema) associated with mild to moderate rosacea.

• There are no adequate, well-controlled studies of azelaic acid gel in pregnant women, so it should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
• Animal studies with oral azelaic acid showed some effects on fetal development only at doses that were also toxic to the mother, and no teratogenic effects were seen.

• Less than 4% of a topically applied dose of azelaic acid is absorbed into the body, and azelaic acid is a normal dietary and endogenous substance, so a significant increase in breast milk levels is not expected; caution should still be exercised when using it while breastfeeding.

• Clinical studies of azelaic acid gel did not include enough patients aged 65 and older to determine whether they respond differently than younger patients.

• The safety and effectiveness of azelaic acid gel in patients under 18 years of age have not been established, and Health Canada has not authorized a pediatric indication.

• Wash and pat the affected skin dry with a mild soap or soapless cleanser before each application.
• Apply a thin layer of azelaic acid gel, about 0.5 g or roughly 2.5 cm, to the entire affected area twice daily, in the morning and evening, and gently massage it in.
• Wash the hands after each application, and avoid occlusive dressings or wrappings over the treated skin.
• Use the gel continuously for the full course of treatment; noticeable improvement is generally seen after 4 to 8 weeks, and total duration varies depending on the severity of rosacea.
• If skin irritation develops, reduce the amount applied or cut back to once daily until irritation resolves, and interrupt treatment for a few days if needed.
• If a dose is missed, skip it and continue with the next scheduled application; do not apply two doses at once.

If overdose is suspected, seek emergency medical attention immediately or contact your regional Poison Control Centre without delay.

• Azelaic acid is applied to the skin, so systemic overdose is highly unlikely.
• Excessive application can cause pronounced local skin irritation at the application site.
• If irritation occurs, applying the medication less often or stopping temporarily until symptoms subside is recommended.
• Animal studies do not suggest that swallowing large amounts of azelaic acid causes acute toxicity.

• Burning, stinging, or tingling of the skin may occur, especially at the start of treatment.
• Itching (pruritus) may occur.
• Scaling or dry skin (xerosis) may occur.
• Redness or irritation (erythema) may occur.
• Localized swelling (edema) may occur.
• Contact dermatitis may occur.
• Acne may occur or worsen.
• Seborrhea (oily skin) may occur.
• Increased sun sensitivity (photosensitivity) may occur.
• Widening of small blood vessels (vasodilatation) may occur.
• Small flesh-colored or pigmented skin growths (nevi) have been reported.
• Excess hair growth (hirsutism) has been reported.
• Localized increased hair growth (hypertrichosis) has been reported.
• Small patches of skin lightening (depigmentation) have been reported.
• Small rough bumps resembling keratosis pilaris have been reported.
• Fungal skin infection (mycosis) has been reported rarely.
• Reactivation or worsening of cold sores (herpes labialis) or other herpes infections may occur.

Serious side effects require immediate discussion with the prescriber or emergency care.

• Allergic hypersensitivity reactions can occur, including swelling of the face, lips, or throat, eye swelling, and difficulty breathing.
• Hives (urticaria) can occur.
• Isolated reports of skin lightening (hypopigmentation) have occurred, of greater concern in patients with darker skin tones.
• Worsening of asthma has been reported rarely.
• Severe local irritation or sensitization may require stopping treatment and starting appropriate therapy.
• Seek medical attention for facial or throat swelling, difficulty breathing, widespread hives, or severe skin irritation that does not improve with reduced use.

• Use with caution in patients with a history of cold sores, since exacerbation of recurrent herpes labialis and herpes simplex or herpes zoster infections has been reported.
• Use with caution around the eyes, mouth, and other mucous membranes, since azelaic acid can cause irritation if it contacts these areas; if this happens, rinse with plenty of water.
• Use with caution in patients with darker skin complexion, monitoring for early signs of hypopigmentation, since azelaic acid has not been well studied in this population.
• Use with caution in patients with a history of asthma, as worsening has been reported rarely.
• Avoid spicy foods, hot foods and drinks, and alcoholic beverages, which can worsen facial flushing associated with rosacea during treatment.
• This medication is for external skin use only and should not be used in the eyes, mouth, rectum, or vagina.
• Use azelaic acid gel only as directed by a physician, and do not exceed the recommended amount or frequency.
• Long-term animal studies have not established the carcinogenic potential of azelaic acid gel in humans, so prolonged use beyond what is directed should be discussed with a physician.

• Contraindicated in patients with a history of hypersensitivity to azelaic acid, propylene glycol, or any other component of the formulation.

• No formal drug interaction studies have been conducted with topical azelaic acid.
• Clinical trials excluded the concomitant use of other medications applied to treat rosacea, so interactions with other rosacea treatments have not been formally assessed.

• No specific food interactions have been established, though spicy foods, hot foods and drinks, and alcohol may aggravate rosacea flushing and are best avoided during treatment.

• Apply azelaic acid gel twice daily, once in the morning and once in the evening, regardless of meals, since it is a topical product with minimal systemic absorption.
• Non-medicated cosmetics free of pore-clogging or irritating ingredients may be applied after the gel has dried.

• Store at room temperature, between 15°C and 30°C.
• Keep out of the reach of children before and after use.

• Azelaic acid (Finacea) gel treats the bumps, pimples, and redness of mild to moderate rosacea when applied twice daily.
• Visible improvement usually takes 4 to 8 weeks of continuous use; do not stop early even if results seem slow.
• Mild burning, stinging, or dryness is common when starting treatment and usually settles; reduce how often you apply it if irritation becomes bothersome.
• Avoid contact with the eyes, mouth, and mucous membranes, and wash your hands after each application.
• Seek medical attention right away for facial swelling, difficulty breathing, or widespread hives, as these can indicate a serious allergic reaction.