Azelaic Acid

AZELAIC ACID- azelaic acid gel
Amneal Pharmaceuticals of New York LLC

1 INDICATIONS AND USAGE

Azelaic Acid Gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. Although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated.

2 DOSAGE AND ADMINISTRATION

  • Apply and gently massage a thin layer of Azelaic Acid Gel, 15% into the affected areas on the face twice daily (morning and evening).

  • Use only very mild soaps or soapless cleansing lotion before application of Azelaic Acid Gel, 15%.

  • Cosmetics may be applied after the application of Azelaic Acid Gel, 15% has dried.

  • Avoid the use of occlusive dressings or wrappings.

  • Instruct patients to avoid spicy foods, thermally hot foods and drinks, alcoholic beverages.

  • Patients should be reassessed if no improvement is observed upon completing 12 weeks of therapy.

  • Not for oral, ophthalmic or intravaginal use.

3 DOSAGE FORMS AND STRENGTHS

Azelaic Acid Gel, 15% is a white to yellowish white opaque gel. Each gram of Azelaic Acid Gel, 15% contains 0.15 gm of azelaic acid (15% w/w).

4 CONTRAINDICATIONS

None.

5 WARNINGS AND PRECAUTIONS

5.1 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 Azelaic Acid Gel, 15% in patients with known hypersensitivity to any component of the gel. If hypersensitivity develops during treatment, discontinue Azelaic Acid Gel, 15% and institute appropriate therapy.

5.2 Skin Reactions

Skin irritation (i.e. pruritus, burning or stinging) may occur during use of Azelaic Acid Gel, 15%, 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.

5.3 Eye and Mucous Membranes Irritation

Avoid contact with the eyes, mouth and other mucous membranes. If Azelaic Acid Gel, 15% 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)].

5.4 Exacerbation of Asthma

Worsening of asthma has been reported in patients using azelaic acid formulations including Azelaic Acid Gel, 15%. Consult a physician if asthma is exacerbated with use of Azelaic Acid Gel, 15%.

6 ADVERSE REACTIONS

6.1 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 Azelaic Acid Gel, 15% 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 Azelaic Acid Gel, 15% compared to 7.1% (9/127) for the active comparator gel at 15 weeks.

Table 1: Adverse Events Occurring in 1% of Subjects in the Rosacea Trials by Treatment Group and Maximum Intensity*

Azelaic Acid Gel, 15%N=457(100%) VehicleN=331(100%)
MildN=99(22%) ModerateN=61(13%) SevereN=27(6%) MildN=46(14%) ModerateN=30(9%) SevereN=5(2%)
Burning/stinging/tingling 71 (16%) 42 (9%) 17 (4%) 8 (2%) 6 (2%) 2 (1%)
Pruritus 29 (6%) 18 (4%) 5 (1%) 9 (3%) 6 (2%) 0 (0%)
Scaling/dry skin/xerosis 21 (5%) 10 (2%) 5 (1%) 31 (9%) 14 (4%) 1 (<1%)
Erythema/irritation 6 (1%) 7 (2%) 2 (<1%) 8 (2%) 4 (1%) 2 (1%)
Contact dermatitis 2 (<1%) 3 (1%) 0 (0%) 1 (<1%) 0 (0%) 0 (0%)
Edema 3 (1%) 2 (<1%) 0 (0%) 3 (1%) 0 (0%) 0 (0%)
Acne 3 (1%) 1 (<1%) 0 (0%) 1 (<1%) 0 (0%) 0 (0%)

*Subjects may have > 1 cutaneous adverse event; thus, the sum of the frequencies of preferred terms may exceed the number of subjects with at least 1 cutaneous adverse event.

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.

Local Tolerability Studies

Azelaic Acid Gel, 15% and its vehicle caused irritant reactions at the application site in human dermal safety studies. Azelaic Acid Gel, 15% 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.

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