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Finacea
Overview
What is Finacea?
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 HO, a
molecular weight of 188.22, and the structural formula:
Azelaic acid is a white, odorless crystalline solid that is poorly soluble in
water at 20°C (0.24%), but freely soluble in boiling water and in ethanol.
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 (as a
preservative), disodium-EDTA, lecithin, medium-chain triglycerides, polyacrylic
acid, polysorbate 80, propylene glycol, purified water, and sodium hydroxide to
adjust pH.
What does Finacea look like?
What are the available doses of Finacea?
Sorry No records found.
What should I talk to my health care provider before I take Finacea?
Sorry No records found
How should I use Finacea?
FINACEA Gel, 15%, is indicated for topical treatment of 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. Patients should be instructed to
avoid spicy foods, thermally hot foods and drinks, alcoholic beverages and to
use only very mild soaps or soapless cleansing lotion for facial cleansing.
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 completing 12 weeks of therapy.
What interacts with Finacea?
FINACEA Gel, 15%, is contraindicated in individuals with a history of hypersensitivity to propylene glycol or any other component of the formulation.
What are the warnings of Finacea?
ESTRING is a vaginal administered product with low systemic absorption following continuous use for 3 months (see ). The estrogen plus progestin substudy of WHI utilized systemically-absorbed oral estrogen/progestin. However, the warnings, precautions, and adverse reactions associated with oral estrogen and/or progestin therapy should be considered in the absence of comparable data with other dosage forms of estrogens and/or progestins.
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.
What are the precautions of Finacea?
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.
Patients using FINACEA Gel, 15%, should receive the following
information and instructions:
There have been no formal studies of the interaction of FINACEA
Gel, 15%, with other drugs.
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 (Ames assay,
HGPRT in V79 cells {Chinese hamster lung cells}, and chromosomal aberration
assay in human lymphocytes) and (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.
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.
Equilibrium dialysis was used to assess human milk partitioning
. 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.
Safety and effectiveness of FINACEA Gel, 15%, in pediatric
patients have not been established.
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.
- 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 ).
- 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.
What are the side effects of Finacea?
Overall, treatment related adverse events, including burning,
stinging/ tingling, dryness/tightness/scaling, itching, and
erythema/irritation/redness, were 19.4% (24/124) for FINACEA Gel, 15%, and 7.1%
(9/127) for the active comparator gel at 15 weeks.
In two vehicle controlled, and one active controlled U.S. clinical studies,
treatment safety was monitored in 788 patients who used twice daily FINACEA Gel,
15%, for 12 weeks (N=333) or for 15 weeks (N=124), or the gel vehicle (N=331)
for 12 weeks
FINACEA Gel, 15%, and its vehicle caused irritant reactions at the
application site in human dermal safety studies. FINACEA 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
studies, but this improvement might be attributed to subject dropouts. No
phototoxicity or photoallergenicity were reported in human dermal safety
studies.
In patients using azelaic acid formulations, the following additional adverse
experiences have been reported rarely: worsening of asthma, vitiligo
depigmentation, small depigmented spots, hypertrichosis, reddening (signs of
keratosis pilaris), and exacerbation of recurrent herpes labialis.
Post-marketing safety-Skin: facial burning and irritation; Eyes:
iridocyclitis on accidental exposure with FINACEA Gel, 15%, to the eye (see
).
| FINACEA® Gel, 15% | N=457 (100%) | Vehicle | ||||||||||
| Mild | n=99 | Moderate | n=61 | Severe | n=27 | Mild | n=46 | Moderate | n=30 | Severe | n=5 | (2%) |
| Burning/ | stinging/ | 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 | 21 (5%) | 10 (2%) | 5 (1%) | 31 (9%) | 14 (4%) | 1 (less than 1%) | ||||||
| Erythema/ | 6 (1%) | 7 (2%) | 2 (less than 1%) | 8 (2%) | 4 (1%) | 2 (1%) | ||||||
| Contact | 2 (less than 1%) | 3 (1%) | 0 (0%) | 1 (less than 1%) | 0 (0%) | 0 (0%) | ||||||
| Edema | 3 (1%) | 2 (less than 1%) | 0 (0%) | 3 (1%) | 0 (0%) | 0 (0%) | ||||||
| Acne | 3 (1%) | 1 (less than 1%) | 0 (0%) | 1 (less than 1%) | 0 (0%) | 0 (0%) |
What should I look out for while using Finacea?
FINACEA Gel, 15%, is contraindicated in individuals with a history of
hypersensitivity to propylene glycol or any other component of the formulation.
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.
What might happen if I take too much Finacea?
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 ).
How should I store and handle Finacea?
GEODON for Injection should be stored at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [See USP Controlled Room Temperature] in dry form. Protect from light. Following reconstitution, GEODON for Injection can be stored, when protected from light, for up to 24 hours at 15°–30°C (59°–86°F) or up to 7 days refrigerated, 2°–8°C (36°–46°F).FINACEA® Gel, 15%, is supplied in tubes in the following size: 50 g - NDC 54868-5236-1StorageStore at 25°C (77°F); excursions permitted between 15-30°C (59-86°F) [See USP Controlled Room Temperature]. Distributed under license; © 2005, Intendis, Inc. All rights reserved. May 2005 Manufactured by Intendis Manufacturing S.p.A., Segrate, Milan, Italy Distributed by: INTENDIS Pine Brook, NJ 07058 6058301 2540870Relabeling of "Additional" barcode label by:FINACEA® Gel, 15%, is supplied in tubes in the following size: 50 g - NDC 54868-5236-1StorageStore at 25°C (77°F); excursions permitted between 15-30°C (59-86°F) [See USP Controlled Room Temperature]. Distributed under license; © 2005, Intendis, Inc. All rights reserved. May 2005 Manufactured by Intendis Manufacturing S.p.A., Segrate, Milan, Italy Distributed by: INTENDIS Pine Brook, NJ 07058 6058301 2540870Relabeling of "Additional" barcode label by:FINACEA® Gel, 15%, is supplied in tubes in the following size: 50 g - NDC 54868-5236-1StorageStore at 25°C (77°F); excursions permitted between 15-30°C (59-86°F) [See USP Controlled Room Temperature]. Distributed under license; © 2005, Intendis, Inc. All rights reserved. May 2005 Manufactured by Intendis Manufacturing S.p.A., Segrate, Milan, Italy Distributed by: INTENDIS Pine Brook, NJ 07058 6058301 2540870Relabeling of "Additional" barcode label by:FINACEA® Gel, 15%, is supplied in tubes in the following size: 50 g - NDC 54868-5236-1StorageStore at 25°C (77°F); excursions permitted between 15-30°C (59-86°F) [See USP Controlled Room Temperature]. Distributed under license; © 2005, Intendis, Inc. All rights reserved. May 2005 Manufactured by Intendis Manufacturing S.p.A., Segrate, Milan, Italy Distributed by: INTENDIS Pine Brook, NJ 07058 6058301 2540870Relabeling of "Additional" barcode label by:FINACEA® Gel, 15%, is supplied in tubes in the following size: 50 g - NDC 54868-5236-1StorageStore at 25°C (77°F); excursions permitted between 15-30°C (59-86°F) [See USP Controlled Room Temperature]. Distributed under license; © 2005, Intendis, Inc. All rights reserved. May 2005 Manufactured by Intendis Manufacturing S.p.A., Segrate, Milan, Italy Distributed by: INTENDIS Pine Brook, NJ 07058 6058301 2540870Relabeling of "Additional" barcode label by:FINACEA® Gel, 15%, is supplied in tubes in the following size: 50 g - NDC 54868-5236-1StorageStore at 25°C (77°F); excursions permitted between 15-30°C (59-86°F) [See USP Controlled Room Temperature]. Distributed under license; © 2005, Intendis, Inc. All rights reserved. May 2005 Manufactured by Intendis Manufacturing S.p.A., Segrate, Milan, Italy Distributed by: INTENDIS Pine Brook, NJ 07058 6058301 2540870Relabeling of "Additional" barcode label by:FINACEA® Gel, 15%, is supplied in tubes in the following size: 50 g - NDC 54868-5236-1StorageStore at 25°C (77°F); excursions permitted between 15-30°C (59-86°F) [See USP Controlled Room Temperature]. Distributed under license; © 2005, Intendis, Inc. All rights reserved. May 2005 Manufactured by Intendis Manufacturing S.p.A., Segrate, Milan, Italy Distributed by: INTENDIS Pine Brook, NJ 07058 6058301 2540870Relabeling of "Additional" barcode label by:FINACEA® Gel, 15%, is supplied in tubes in the following size: 50 g - NDC 54868-5236-1StorageStore at 25°C (77°F); excursions permitted between 15-30°C (59-86°F) [See USP Controlled Room Temperature]. Distributed under license; © 2005, Intendis, Inc. All rights reserved. May 2005 Manufactured by Intendis Manufacturing S.p.A., Segrate, Milan, Italy Distributed by: INTENDIS Pine Brook, NJ 07058 6058301 2540870Relabeling of "Additional" barcode label by:FINACEA® Gel, 15%, is supplied in tubes in the following size: 50 g - NDC 54868-5236-1StorageStore at 25°C (77°F); excursions permitted between 15-30°C (59-86°F) [See USP Controlled Room Temperature]. Distributed under license; © 2005, Intendis, Inc. All rights reserved. May 2005 Manufactured by Intendis Manufacturing S.p.A., Segrate, Milan, Italy Distributed by: INTENDIS Pine Brook, NJ 07058 6058301 2540870Relabeling of "Additional" barcode label by:FINACEA® Gel, 15%, is supplied in tubes in the following size: 50 g - NDC 54868-5236-1StorageStore at 25°C (77°F); excursions permitted between 15-30°C (59-86°F) [See USP Controlled Room Temperature]. Distributed under license; © 2005, Intendis, Inc. All rights reserved. May 2005 Manufactured by Intendis Manufacturing S.p.A., Segrate, Milan, Italy Distributed by: INTENDIS Pine Brook, NJ 07058 6058301 2540870Relabeling of "Additional" barcode label by:FINACEA® Gel, 15%, is supplied in tubes in the following size: 50 g - NDC 54868-5236-1StorageStore at 25°C (77°F); excursions permitted between 15-30°C (59-86°F) [See USP Controlled Room Temperature]. Distributed under license; © 2005, Intendis, Inc. All rights reserved. May 2005 Manufactured by Intendis Manufacturing S.p.A., Segrate, Milan, Italy Distributed by: INTENDIS Pine Brook, NJ 07058 6058301 2540870Relabeling of "Additional" barcode label by:
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The mechanism(s) by which azelaic acid interferes with the
pathogenic events in rosacea are unknown.
The percutaneous absorption of azelaic acid after 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
Non-Clinical Toxicology
FINACEA Gel, 15%, is contraindicated in individuals with a history of hypersensitivity to propylene glycol or any other component of the formulation.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.
Drug Interactions:
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.
Patients using FINACEA Gel, 15%, should receive the following information and instructions:
There have been no formal studies of the interaction of FINACEA Gel, 15%, with other drugs.
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 (Ames assay, HGPRT in V79 cells {Chinese hamster lung cells}, and chromosomal aberration assay in human lymphocytes) and (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.
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.
Equilibrium dialysis was used to assess human milk partitioning . 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.
Safety and effectiveness of FINACEA Gel, 15%, in pediatric patients have not been established.
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.
Overall, treatment related adverse events, including burning, stinging/ tingling, dryness/tightness/scaling, itching, and erythema/irritation/redness, were 19.4% (24/124) for FINACEA Gel, 15%, and 7.1% (9/127) for the active comparator gel at 15 weeks.
In two vehicle controlled, and one active controlled U.S. clinical studies, treatment safety was monitored in 788 patients who used twice daily FINACEA Gel, 15%, for 12 weeks (N=333) or for 15 weeks (N=124), or the gel vehicle (N=331) for 12 weeks
FINACEA Gel, 15%, and its vehicle caused irritant reactions at the application site in human dermal safety studies. FINACEA 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 studies, but this improvement might be attributed to subject dropouts. No phototoxicity or photoallergenicity were reported in human dermal safety studies.
In patients using azelaic acid formulations, the following additional adverse experiences have been reported rarely: worsening of asthma, vitiligo depigmentation, small depigmented spots, hypertrichosis, reddening (signs of keratosis pilaris), and exacerbation of recurrent herpes labialis.
Post-marketing safety-Skin: facial burning and irritation; Eyes: iridocyclitis on accidental exposure with FINACEA Gel, 15%, to the eye (see ).
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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