Finacea

FINACEA- azelaic acid gel
LEO Pharma Inc.

1 INDICATIONS AND USAGE

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

Limitations of Use

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

  • Cleanse affected area(s) using only very mild soaps or soapless cleansing lotion and pat dry with a soft towel before application of FINACEA Gel.
  • Apply and gently massage a thin layer of FINACEA Gel into the affected areas on the face twice daily (morning and evening).
  • Wash hands immediately following application of FINACEA Gel.
  • Cosmetics may be applied after the application of FINACEA Gel has dried.
  • Reassess the diagnosis if no improvement is observed upon completing 12 weeks of therapy.
  • Avoid the use of occlusive dressings or wrappings.
  • Instruct patients to avoid use of alcoholic cleansers, tinctures and astringents, abrasives and peeling agents.
  • For topical use.
  • Not for oral, ophthalmic or intravaginal use.

3 DOSAGE FORMS AND STRENGTHS

FINACEA (azelaic acid) Gel, 15% is a white to yellowish white opaque gel. Each gram of FINACEA Gel 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 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.

5.2 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.

5.3 Eye and Mucous Membranes Irritation

FINACEA Gel has been reported to cause irritation of the eyes. Avoid contact with the eyes, mouth and other mucous membranes. If FINACEA Gel comes 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 FINACEA Gel. Consult a physician if asthma is exacerbated with use of FINACEA Gel.

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 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.

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

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

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.

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