Tolerability and Safety


Tolerability and safety of Fabior foam

FABIOR Foam was well tolerated with once-daily treatment over 12 weeks1,2

Incidence of treatment-related adverse reactions in ≥1% of patients treated with FABIOR Foam

FABIOR Foam (N=744) VEHICLE Foam (N=741)
Any adverse reaction 22% 3%
Application site irritation 14% 1%
Application site dryness 7% 1%
Application site erythema 6% <1%
Application site exfoliation 6% <1%
Application site pain 1% 0%
Application site photosensitivity (including sunburn) 1% <1%
Application site pruritus 1% <1%
Application site dermatitus 1% <1%

Additional adverse reactions reported in <1% of patients treated with FABIOR Foam included application site reactions (including discoloration, discomfort, edema, rash, and swelling), dermatitis, impetigo, and pruritus.

Local skin reactions peaked at week 2 and gradually reduced thereafter with continued use of FABIOR Foam. Mean tolerability scores for dryness, erythema, and peeling were similar to baseline by the end of the studies.1

Discontinuation rates due to adverse reactions were low for both FABIOR Foam and vehicle foam.1

Discontinuation rates due to adverse reactions were low for both FABIOR Foam (less than 3%) and vehicle foam (less than 1%)

Patients discontinued use of FABIOR Foam due to local skin reactions.

FABIOR Foam was well tolerated, with similar tolerability across gender, age group, race, and baseline severity (IGA score)1,3

Patients with any treatment-related adverse reaction in <1% of patients treated with FABIOR Foam FABIOR Foam (N=744) VEHICLE Foam (N=741)
Males (n=729) 22% 2%
Females (n=756) 22% 3%
Age 12-17 (n=860) 22% 1%
Age 18-25 (n=428) 19% 5%
Age 26-35 (n=143) 29% 3%
Age 36-45 (n=54) 27% 6%
White (n=1150) 21% 3%
Black (n=219) 24% 4%
Other (n=116) 23% 0%
Baseline IGA 3 (n=1192) 23% 3%
Baseline IGA 4 (n=293) 19% 1%

References: 1. Stein Gold L, Jasper S. Tazarotene foam 0.1% for Acne Vulgaris: analysis of integrated efficacy and safety data by race. Presented at: Proceedings of the Summer Academy Meeting American Academy of Dermatology; August 15-19, 2012; Boston, MA. 2. FABIOR Foam [package insert]. Greenville, NC: Mayne Pharma; 2016. 3. Data on file. Greenville, NC; Mayne Pharma LLC.

Indication

FABIOR Foam is a retinoid indicated for the topical treatment of acne vulgaris in patients 12 years of age or older.

For more information, please see full Prescribing Information and Patient Information Leaflet

Important Safety Information

  • FABIOR Foam is contraindicated in pregnancy. FABIOR Foam may cause fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, treatment should be discontinued and the patient apprised of the potential hazard to the fetus. Females of child-bearing potential should be warned of the potential risk and use of adequate birth-control measures when tazarotene foam is used. The possibility of pregnancy should be considered in females of child-bearing potential at the time of institution of therapy.
  • FABIOR Foam should be used with caution in patients with history of local tolerability reactions or local hypersensitivity.
  • The propellant in FABIOR Foam is flammable. Instruct the patient to avoid fire, flame, and/or smoking during and immediately following application.
  • Because of heightened burning susceptibility, exposure to sunlight (including sunlamps) should be avoided when using FABIOR Foam. Patients must be warned to use sunscreens and protective clothing. Patients with sunburn should be advised not to use FABIOR Foam until fully recovered. Patients who may have considerable sun exposure due to their occupation and those patients with inherent sensitivity to sunlight should exercise particular caution. FABIOR Foam should be used with caution in patients with a personal or family history of skin cancer or if the patient is also taking drugs known to be photosensitizers.
  • FABIOR Foam may cause skin redness, peeling, burning, or excessive pruritus. Concomitant topical acne therapy should be used with caution because a cumulative irritant effect may occur. If skin irritation occurs, therapy with FABIOR Foam should be reduced to an interval the patient can tolerate, temporarily interrupted, or discontinued. In addition, dermatologic medications and cosmetics that have a strong drying effect should be avoided
  • Retinoids should not be used on abraded or eczematous skin, as they may cause severe irritation. Contact with the mouth, eyes, and mucous membranes should be avoided. Weather extremes, such as wind or cold, may be more irritating to patients using FABIOR Foam. Excessive topical application of FABIOR Foam may lead to marked redness, peeling, or discomfort.

Medical Information & Adverse Drug Events Reporting

To report a suspected adverse reaction from one of our products, please contact Mayne Pharma at 1-844-825-8500 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.