Finacea
(azelaic acid)Dosage & Administration
By using PrescriberAI, you agree to the AI Terms of Use.
Finacea Prescribing Information
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.
- 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.
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).
Pregnancy
Risk Summary
Azelaic acid is minimally absorbed systemically following topical route of administration, and maternal use is not expected to result in fetal exposure to the drug [see Clinical Pharmacology (12.3)].
In animal reproduction studies, embryofetal toxicity was noted when azelaic acid was administered orally during the period of organogenesis at doses 162, 19, and 65 times the maximum recommended human dose (MRHD) in rats, rabbits, and monkeys, respectively. Maternal toxicity was noted at these doses but no malformations were observed in these embryofetal developmental studies (see Data).
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Data
Animal Data
Dermal embryofetal developmental toxicology studies have not been performed with azelaic acid, 15% gel. Oral embryofetal developmental studies were conducted with azelaic acid in rats, rabbits, and cynomolgus monkeys. Azelaic acid was administered during the period of organogenesis in all three animal species. Embryotoxicity was observed in rats, rabbits, and monkeys at oral doses of azelaic acid that generated some maternal toxicity. Embryotoxicity was observed in rats given 2500 mg/kg/day [162 times the MRHD based on body surface area (BSA) comparison], rabbits given 150 or 500 mg/kg/day (19 or 65 times the MRHD based on BSA comparison) and cynomolgus monkeys given 500 mg/kg/day (65 times the MRHD based on BSA comparison) azelaic acid. No malformations were observed in the oral embryofetal developmental studies conducted in rats, rabbits and cynomolgus monkeys.
An oral peri- and post-natal developmental study was conducted in rats. Azelaic acid was administered from gestational day 15 through day 21 postpartum up to a dose level of 2500 mg/kg/day. Embryotoxicity was observed in rats at an oral dose of 2500 mg/kg/day (162 times the MRHD based on BSA comparison) that generated some maternal toxicity. In addition, slight disturbances in the post-natal development of fetuses was noted in rats at oral doses that generated some maternal toxicity (500 and 2500 mg/kg/day; 32 and 162 times the MRHD based on BSA comparison). No effects on sexual maturation of the fetuses were noted in this study.
Lactation
Risk Summary
Azelaic acid is naturally present in human milk. When used as prescribed, azelaic acid is unlikely to be absorbed through the skin in clinically relevant amounts to cause a change in azelaic acid concentration in milk or milk production; therefore, breastfeeding is not expected to result in exposure of the infant to FINACEA Gel. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for FINACEA Gel and any potential adverse effects on the breastfed child from FINACEA Gel or from the underlying maternal condition.
Pediatric Use
The safety and effectiveness of FINACEA Gel have not been established in pediatric patients.
Geriatric Use
Clinical studies of FINACEA Gel did not include sufficient numbers of subjects aged 65 and over to determine if they respond differently than younger subjects.
None.
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
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)].
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.