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6706803

CLEAR:No papules and/or pustules; no or residual erythema; no or mild tomoderate telangiectasia MINIMAL:Rare papules and/or pustules; residual to mild erythema; mild tomoderate telangiectasia For Dermatologic Use Only–Not for Ophthalmic, Oral, or Intravaginal
Few papules and/or pustules; mild erythema; mild to moderate DESCRIPTION
Distinct number of papules and/or pustules; mild to moderate erythema; FINACEA® (azelaic acid) Gel, 15%, contains azelaic acid, a naturally occurring saturated dicarboxylic acid. Chemically, azelaic acid is 1,7- heptanedicarboxylic acid, with the molecular formula C H Pronounced number of papules and/or pustules; moderate erythema; weight of 188.22, and the structural formula: Many papules and/or pustules, occasionally with large inflamed lesions; moderate erythema; moderate degree of telangiectasia Azelaic acid is a white, odorless crystalline solid that is poorly soluble in Numerous papules and/or pustules, occasionally with confluent areas water at 20°C (0.24%), but freely soluble in boiling water and in ethanol. of inflamed lesions; moderate or severe erythema; moderate or severe Each gram of FINACEA Gel, 15%, contains 0.15 gm azelaic acid (15% w/w) as the active ingredient in an aqueous gel base containing benzoic acid Primary efficacy assessment was based on the intent-to-treat (ITT) (as a preservative), disodium EDTA, lecithin, medium-chain triglycerides, population with last observation carried forward (LOCF). polyacrylic acid, polysorbate 80, propylene glycol, purified water, and Both studies demonstrated a statistically significant difference in favor of FINACEA Gel, 15%, over its vehicle in reducing the number CLINICAL PHARMACOLOGY
of inflammatory papules and pustules associated with rosacea (Table The mechanism(s) by which azelaic acid interferes with the pathogenic 1) and with success on the IGA in the ITT-LOCF population at the end Pharmacokinetics: The percutaneous absorption of azelaic acid after Table 1. Inflammatory Papules and Pustules (ITT population)1
topical application of FINACEA Gel, 15%, could not be reliably determined.
Mean plasma azelaic acid concentrations in rosacea patients treated with FINACEA Gel, 15%, twice daily for at least 8 weeks are in the range of 42 to 63.1 ng/mL. These values are within the maximum concentration range of 24.0 to 90.5 ng/mL observed in rosacea patients treated with vehicle only. This indicates that FINACEA Gel, 15%, does not increase plasma azelaic acid concentration beyond the range derived from nutrition and endogenous metabolism. In vitro and human data suggest negligible cutaneous metabolism of 3H-azelaic acid 20% cream after topical application. Azelaic acid is mainly excreted unchanged in the urine, but undergoes some ß-oxidation to shorter chain dicarboxylic acids.
CLINICAL STUDIES
FINACEA Gel, 15%, was evaluated for the treatment of mild to moderate papulopustular rosacea in 2 clinical trials comprising a total of 664 (333 1ITT population with last observation carried forward (LOCF); active to 331 vehicle) patients. Both trials were multicenter, randomized, Although some reduction of erythema which was present in patients double-blind, vehicle-controlled 12-week studies with identical protocols.
with papules and pustules of rosacea occurred in clinical studies, Overall, 92.5% of patients were Caucasian and 73% of patients were efficacy for treatment of erythema in rosacea in the absence of papules women, and the mean age was 49 (range 21 to 86) years. Enrolled and pustules has not been evaluated.
patients had mild to moderate rosacea with a mean lesion count of 18 FINACEA Gel, 15%, was superior to the vehicle with regard to success (range 8 to 60) inflammatory papules and pustules. Subjects without based on the investigator’s global assessment of rosacea on a 7-point papules and pustules, with nodules, rhinophyma, or ocular involvement, static score at the end of treatment, (ITT population; Table 2). and a history of hypersensitivity to propylene glycol or to any otheringredients of the study drug were excluded. FINACEA Gel, 15%, or its Table 2. Investigator’s Global Assessment at the End of Treatment1
vehicle were to be applied twice daily for 12 weeks; no other topical or systemic medication affecting the course of rosacea and/or evaluability was to be used during the studies. Patients were instructed to avoid spicy foods, thermally hot foods and drinks, and alcoholic beverages during the study, and to use only very mild soaps or soapless cleansing The primary efficacy endpoints were both 1) change from baseline in inflammatory lesion counts and 2) success defined as a score of clear or minimal with at least a 2 step reduction from baseline on theInvestigator’s Global Assessment (IGA): 1ITT population with last observation carried forward (LOCF); INDICATIONS AND USAGE
animals with papillomas at the treatment site was observed in male Tg.
FINACEA Gel, 15%, is indicated for topical treatment of inflammatory AC animals after once daily application. After twice daily application, papules and pustules of mild to moderate rosacea. Although some FINACEA Gel, 15%, and the gel vehicle induced a statistically significant reduction of erythema which was present in patients with papules and increase in the number of male animals with papillomas at the treatment pustules of rosacea occurred in clinical studies, efficacy for treatment site when compared to untreated males. This suggests that the positive of erythema in rosacea in the absence of papules and pustules has not effect may be associated with the vehicle application. The clinical been evaluated. Patients should be instructed to avoid spicy foods, relevance of the findings in animals to humans is not clear. thermally hot foods and drinks, alcoholic beverages and to use only Azelaic acid was not mutagenic or clastogenic in a battery of in vitro very mild soaps or soapless cleansing lotion for facial cleansing.
(Ames assay, HGPRT in V79 cells {Chinese hamster lung cells}, and CONTRAINDICATIONS
chromosomal aberration assay in human lymphocytes) and in vivo FINACEA Gel, 15%, is contraindicated in individuals with a history of (dominant lethal assay in mice and mouse micronucleus assay) hypersensitivity to propylene glycol or any other component of the Oral administration of azelaic acid at dose levels up to 2500 mg/kg/day(162 times the maximum recommended human dose based on body WARNINGS
surface area) did not affect fertility or reproductive performance in male FINACEA Gel, 15%, is for dermatologic use only, and not for ophthalmic, oral or intravaginal use.
There have been isolated reports of hypopigmentation after use of azelaic Pregnancy: Teratogenic Effects: Pregnancy Category B
acid. Since azelaic acid has not been well studied in patients with dark There are no adequate and well-controlled studies of topically complexion, these patients should be monitored for early signs of administered azelaic acid in pregnant women. The experience with FINACEA Gel, 15%, when used by pregnant women is too limited topermit assessment of the safety of its use during pregnancy.
PRECAUTIONS
Dermal embryofetal developmental toxicology studies have not been General: Contact with the eyes should be avoided. If sensitivity or
performed with azelaic acid, 15%, gel. Oral embryofetal developmental severe irritation develops with the use of FINACEA Gel, 15%, treatment studies were conducted with azelaic acid in rats, rabbits, and cynomolgus should be discontinued and appropriate therapy instituted.
monkeys. Azelaic acid was administered during the period of In a transgenic mouse study, chronic use of FINACEA Gel led to an organogenesis in all three animal species. Embryotoxicity was increased number of animals with papillomas at the treatment site (see
observed in rats, rabbits, and monkeys at oral doses of azelaic acid that PRECAUTIONS: Carcinogenesis, Mutagenesis, and Impairment of
generated some maternal toxicity. Embryotoxicity was observed in rats Fertility). The clinical relevance of the findings in animal studies to
given 2500 mg/kg/day (162 times the maximum recommended human dose based on body surface area), rabbits given 150 or 500 mg/kg/day Information for Patients: Patients using FINACEA Gel, 15%, should
(19 or 65 times the maximum recommended human dose based on receive the following information and instructions: body surface area) and cynomolgus monkeys given 500 mg/kg/day (65 • FINACEA Gel, 15%, is to be used only as directed by the physician.
times the maximum recommended human dose based on body surface • FINACEA Gel, 15%, is for external use only. It is not to be used orally, area) azelaic acid. No teratogenic effects were observed in the oral embryofetal developmental studies conducted in rats, rabbits and • Cleanse affected area(s) with a very mild soap or a soapless cleansing lotion and pat dry with a soft towel before applying FINACEA Gel, 15%.
An oral peri- and post-natal developmental study was conducted in rats.
Avoid alcoholic cleansers, tinctures and astringents, abrasives and Azelaic acid was administered from gestational day 15 through day 21 postpartum up to a dose level of 2500 mg/kg/day. Embryotoxicity was • Avoid contact of FINACEA Gel, 15%, with the mouth, eyes and other observed in rats at an oral dose that generated some maternal toxicity mucous membranes. If it does come in contact with the eyes, wash (2500 mg/kg/day; 162 times the maximum recommended human dose the eyes with large amounts of water and consult a physician if eye based on body surface area). In addition, slight disturbances in the post-natal development of fetuses was noted in rats at oral doses that • The hands should be washed following application of FINACEA Gel, 15%. generated some maternal toxicity (500 and 2500 mg/kg/day; 32 and • Cosmetics may be applied after FINACEA Gel, 15%, has dried.
162 times the maximum recommended human dose based on body • Skin irritation (e.g., pruritus, burning, or stinging) may occur during surface area). No effects on sexual maturation of the fetuses were noted use of FINACEA Gel, 15%, usually during the first few weeks of treatment. If irritation is excessive or persists, use of FINACEA Gel, Because animal reproduction studies are not always predictive of 15%, should be discontinued, and patients should consult their human response, this drug should be used only if clearly needed during physician (See ADVERSE REACTIONS).
• Avoid any foods and beverages that might provoke erythema, flushing, Nursing Mothers: Equilibrium dialysis was used to assess human milk
and blushing (including spicy food, alcoholic beverages, and thermally partitioning in vitro. At an azelaic acid concentration of 25 µg/mL, the hot drinks, including hot coffee and tea).
milk/plasma distribution coefficient was 0.7 and the milk/buffer • Patients should report abnormal changes in skin color to their physician.
distribution was 1.0, indicating that passage of drug into maternal milk • Avoid the use of occlusive dressings or wrappings.
may occur. Since less than 4% of a topically applied dose of azelaic acid Drug Interactions: There have been no formal studies of the interaction
cream, 20%, is systemically absorbed, the uptake of azelaic acid into of FINACEA Gel, 15%, with other drugs.
maternal milk is not expected to cause a significant change from baselineazelaic acid levels in the milk. However, caution should be exercised Carcinogenesis, Mutagenesis, Impairment of Fertility:
when FINACEA Gel, 15%, is administered to a nursing mother.
Systemic long-term animal studies have not been performed toevaluate the carcinogenic potential of azelaic acid. In a 26-week Pediatric Use: Safety and effectiveness of FINACEA Gel, 15%, in
dermal carcinogenicity study using transgenic (Tg.AC) mice, FINACEA pediatric patients have not been established.
Gel, 15%, and the gel vehicle, when applied once or twice daily, did not Geriatric: Clinical studies of FINACEA Gel, 15%, did not include
increase the number of female Tg. AC animals with papillomas at the sufficient numbers of subjects aged 65 and over to determine treatment site. No statistically significant increase in the number of whether they respond differently from younger subjects.
ADVERSE REACTIONS
course of the clinical studies, but this improvement might be attributed Overall, treatment related adverse events, including burning, stinging/ to subject dropouts. No phototoxicity or photoallergenicity were reported tingling, dryness/tightness/ scaling, itching, and erythema/irritation/ redness, were 19.4% (24/124) for FINACEA Gel, 15%, and 7.1% In patients using azelaic acid formulations, the following additional (9/127) for the active comparator gel at 15 weeks. adverse experiences have been reported rarely: worsening of asthma, In two vehicle controlled, and one active controlled U.S. clinical studies, vitiligo depigmentation, small depigmented spots, hypertrichosis, treatment safety was monitored in 788 patients who used twice daily reddening (signs of keratosis pilaris), and exacerbation of recurrent FINACEA Gel, 15%, for 12 weeks (N=333) or for 15 weeks (N=124), or the gel vehicle (N=331) for 12 weeks.
Post-marketing safety-Skin: facial burning and irritation; Eyes: iridocyclitison accidental exposure with FINACEA Gel, 15%, to the eye (see Table 3. Cutaneous Adverse Events Occurring in 1% of Subjects in
PRECAUTIONS).
the Rosacea Trials by Treatment Group and Maximum Intensity*
OVERDOSAGE
FINACEA Gel, 15%, is intended for cutaneous use only. If pronounced local irritation occurs, patients should be directed to discontinue use and appropriate therapy should be instituted (See PRECAUTIONS).
DOSAGE AND ADMINISTRATION
A thin layer of FINACEA Gel, 15%, should be gently massaged into the affected areas on the face twice daily, in the morning and evening.
Patients should be reassessed if no improvement is observed upon HOW SUPPLIED
FINACEA Gel, 15%, is supplied in tubes in the following size: FINACEA Gel, 15% – 50 g tube – NDC 10922-825-02 Store at 25°C (77°F); excursions permitted between 15–30°C (59–86°F) [See USP Controlled Room Temperature].
Distributed under license; U.S. Patent No 6,534,070 2010, Intendis, Inc. All rights reserved, July 2010 Manufactured by Intendis Manufacturing S.p.A., Segrate, Milan, Italy *Subjects may have >1 cutaneous adverse event; thus, the sum of the frequencies of preferred terms may exceed the number of subjects withat least 1 cutaneous adverse event.
FINACEA Gel, 15%, and its vehicle caused irritant reactions at the appli-cation site in human dermal safety studies. FINACEA Gel, 15%, caused significantly more irritation than its vehicle in a cumulative irritationstudy. Some improvement in irritation was demonstrated over the

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