WARNINGS
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
acid. Since azelaic acid has not been well studied in patients with dark
complexion, these patients should be monitored for early signs of
hypopigmentation.
PRECAUTIONS
General:
Contact with the eyes should be avoided. If sensitivity or severe
irritation develops with the use of FINACEA Gel, 15%, treatment should be
discontinued and appropriate therapy instituted.
Information For Patients
Patients using FINACEA Gel, 15%, should receive the following
information and instructions:
- FINACEA Gel, 15%, is to be used only as directed by the physician.
- FINACEA Gel, 15%, is for external use only. It is not to be used orally,
intravaginally, or for the eyes.
- 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%. Avoid
alcoholic cleansers, tinctures and astringents, abrasives and peeling agents.
- Avoid contact of FINACEA Gel, 15%, with the mouth, eyes and other mucous
membranes. If it does come in contact with the eyes, wash the eyes with large
amounts of water and consult a physician if eye irritation persists.
- The hands should be washed following application of FINACEA Gel, 15%.
- Cosmetics may be applied after FINACEA Gel, 15%, has dried.
- Skin irritation (e.g., pruritus, burning, or stinging) may occur during use
of FINACEA Gel, 15%, usually during the first few weeks of treatment. If
irritation is excessive or persists, use of FINACEA Gel, 15%, should be
discontinued, and patients should consult their physician (See
ADVERSE REACTIONS
).
- Avoid any foods and beverages that might provoke erythema, flushing, and
blushing (including spicy food, alcoholic beverages, and thermally hot drinks,
including hot coffee and tea).
- Patients should report abnormal changes in skin color to their physician.
- Avoid the use of occlusive dressings or wrappings.
Drug interactions:
There have been no formal studies of the interaction of FINACEA
Gel, 15%, with other drugs.
Carcinogenesis, mutagenesis, impairment of
fertility:
Long-term animal studies have not been performed to evaluate the
carcinogenic potential of FINACEA Gel, 15%. Azelaic acid was not mutagenic or
clastogenic in a battery of in vitro (Ames assay,
HGPRT in V79 cells {Chinese hamster lung cells}, and chromosomal aberration
assay in human lymphocytes) and in vivo (dominant
lethal assay in mice and mouse micronucleus assay) genotoxicity tests.
Oral administration of azelaic acid at dose levels up to 2500 mg/kg/day (162
times the maximum recommended human dose based on body surface area) did not
affect fertility or reproductive performance in male or female rats.
Pregnancy:
Teratogenic effects
Pregnancy Category B
There are no adequate and well-controlled studies of topically
administered azelaic acid in pregnant women. The experience with FINACEA Gel,
15%, when used by pregnant women is too limited to permit assessment of the
safety of its use during pregnancy.
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 maximum recommended human
dose based on body surface area), rabbits given 150 or 500 mg/kg/day (19 or 65
times the maximum recommended human dose based on body surface area) and
cynomolgus monkeys given 500 mg/kg/day (65 times the maximum recommended human
dose based on body surface area) azelaic acid. No teratogenic effects 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 that generated some maternal toxicity (2500 mg/kg/day; 162 times the
maximum recommended human dose based on body surface area). In addition, slight
disturbances in the postnatal 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 maximum recommended human dose based on body surface area). No effects
on sexual maturation of the fetuses were noted in this study.
Because animal reproduction studies are not always predictive of human
response, this drug should be used only if clearly needed during
pregnancy.
Nursing mothers:
Equilibrium dialysis was used to assess human milk partitioning
in vitro. At an azelaic acid concentration of 25
μg/mL, the milk/ plasma distribution coefficient was 0.7 and the milk/buffer
distribution was 1.0, indicating that passage of drug into maternal milk may
occur. Since less than 4% of a topically applied dose of azelaic acid cream,
20%, is systemically absorbed, the uptake of azelaic acid into maternal milk is
not expected to cause a significant change from baseline azelaic acid levels in
the milk. However, caution should be exercised when FINACEA Gel, 15%, is
administered to a nursing mother.
Pediatric use:
Safety and effectiveness of FINACEA Gel, 15%, in pediatric
patients have not been established.
Geriatric use:
Clinical studies of FINACEA Gel, 15%, did not include sufficient
numbers of subjects aged 65 and over to determine whether they respond
differently from younger subjects.
|
