Fabior

Approved 11 May 2012TopicalAerosol, foam

Indications

Tazarotene Foam, 0.1% is indicated for the topical treatment of acne vulgaris in patients 12 years of age or older. Tazarotene Foam is a retinoid indicated for the topical treatment of acne vulgaris in patients 12 years of age or older. ( 1 )

Contraindications

Tazarotene Foam is contraindicated in pregnancy. Tazarotene Foam may cause fetal harm when administered to a pregnant woman. Tazarotene elicits teratogenic and developmental effects associated with retinoids after topical or systemic administration in rats and rabbits [see Use in Specific Populations (8.1 , 8.3) ]. 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 [see Warnings and Precautions (5.1) , Use in Specific Populations (8.1 , 8.3) ].

Pregnancy. ( 4 , 8.1 )

Warnings and precautions

Fetal Risk: Tazarotene Foam contains tazarotene, which is a teratogenic substance. Tazarotene Foam is contraindicated in pregnancy. Females of childbearing potential should have a negative pregnancy test within 2 weeks prior to initiating treatment and use an effective method of contraception during treatment. ( 5.1 ) Local Irritation: Use with caution in patients with a history of local tolerability reactions or local hypersensitivity.

( 5.2 ) Potential Irritant Effect with Concomitant Topical Medications: Use with caution because a cumulative irritant effect may occur. ( 5.3 ) Photosensitivity and Risk for Sunburn: Avoid exposure to sunlight, sunlamps, and weather extremes. Wear sunscreen daily. ( 5.4 ) Contents are flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application. ( 5.5 )

5.1Fetal Risk

Systemic exposure to tazarotenic acid is dependent upon the extent of the body surface area treated. In patients treated topically over sufficient body surface area, exposure could be in the same order of magnitude as in orally treated animals. Tazarotene is a teratogenic substance, and it is not known what level of exposure is required for teratogenicity in humans [see Clinical Pharmacology (12) ] . There were 5 reported pregnancies in subjects who participated in clinical trials for topical tazarotene foam.

One of the subjects was found to have been treated with topical tazarotene for 25 days, 2 were treated with vehicle foam, and the other 2 did not receive either tazarotene foam or vehicle foam. The subjects were discontinued from the trials when their pregnancy was reported. The one pregnant woman who was inadvertently exposed to topical tazarotene during the clinical trial delivered a full-term healthy infant. Females of Childbearing Potential: Females of child-bearing potential should be warned of the potential risk and use adequate birth-control measures when tazarotene foam is used.

At a glance

Brand name: Fabior
Active substance: tazarotene
Drug class: Other antipsoriatics for topical use
Route: Topical
Dosage form: Aerosol, foam
Applicant: Mayne Pharma
Status: Prescription
FDA approval: 11 May 2012
Application: NDA202428-001
RxCUI: 1293452

Contraindications

Pregnancy. ( 4 , 8.1 )

Warnings and precautions

5.1Fetal Risk

Pregnancy and breastfeeding

8.1Pregnancy Tazarotene

Foam is contraindicated in pregnancy [see Contraindications (4) ]. There are no adequate and well -controlled studies with Tazarotene Foam in pregnant women. Tazarotene Foam is contraindicated in females who are or may become pregnant [see Contraindications (4) ]. 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 that a female of child-bearing potential is pregnant at the time of institution of therapy should be considered.

A negative serum or urine result for pregnancy test having a sensitivity down to at least 25 mlU/mL for hCG should be obtained within 2 weeks prior to therapy with Tazarotene Foam, which should begin during a normal menstrual period for females of childbearing potential. In rats, tazarotene 0.05% gel administered topically during gestation days 6 through 17 at 0.25 mg/kg/day resulted in reduced fetal body weights and reduced skeletal ossification.

Rabbits dosed topically with 0.25 mg/kg/day tazarotene gel during gestation days 6 through 18 were noted with single incidences of known retinoid malformations, including spina bifida, hydrocephaly, and heart anomalies. Systemic exposure (AUC) to tazarotenic acid at topical doses of 0.25 mg/kg/day tazarotene in a gel formulation in rats and rabbits were 15 to 166 times, respectively, the AUC in acne patients treated with 2 mg/cm 2 of Tazarotene Foam 0.1% over a 15% body surface acrea.

A with other retinoids, when tazarotene was administered orally to experimental animals, developmental delays were seen in rats, and teratogenic effects and post-implantation loss were observed in rats and rabbits at doses 13 and 325 times, respectively, the AUC to tazarotenic acid in acne patients treated with 2 mg/cm 2 of Tazarotene Foam 0.1% over a 15% body surface area. In female rats orally administered 2 mg/kg/day tazarotene from 15 days before mating through gestation day 7, a number of classic developmental effects of retinoids were observed including decreased number of implantation sites, decreased litter size, decreased numbers of live fetuses, and decreased fetal body weights.

A low incidence of retinoid-related malformations was also observed. AUC in rats was 42 times the AUC in acne patients treated with 2 mg/cm 2 of Tazarotene Foam 0.1% over a 15% body surface area.

Adverse reactions

Most common adverse reactions reported at an incidence ≥6% are application site irritation, application site dryness, application site erythema, and application site exfoliation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma at 1-844-825-8500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data reflect exposure to Tazarotene Foam in 744 subjects with acne vulgaris. Subjects were aged 12 to 45 years and were treated once daily in the evening for 12 weeks.

Adverse reactions reported in ≥ 1% of subjects treated with Tazarotene Foam are presented in Table 1. Most adverse reactions were mild to moderate in severity. Severe adverse reactions represented 3.0% of the subjects treated. Overall, 2.7% (20/744) of subjects discontinued Tazarotene Foam because of local skin reactions. Table 1. Incidence of Adverse Reactions in ≥1 % of Subjects Treated with Tazarotene Foam Tazarotene Foam N = 744 Vehicle Foam N = 741 Patients with any adverse reaction, n (%) 163 (22) 19 (3) Application site irritation 107 (14) 9 (1) Application site dryness 50 (7) 8 (1) Application site erythema 48 (6) 3 (<1) Application site exfoliation 44 (6) 3 (<1) Application site pain 9 (1) 0 Application site photosensitivity (including sunburn) 8 (1) 3 (<1) Application site pruritus 7 (1) 3 (<1) Application site dermatitis 6 (1) 1 (<1) Additional adverse reactions that were reported in <1% of subjects treated with Tazarotene Foam included application site reactions (including discoloration, discomfort, edema, rash, and swelling), dermatitis, impetigo, and pruritus.

Local skin reactions, dryness, erythema, and peeling actively assessed by the investigator and burning/stinging and itching reported by the subject were evaluated at baseline, during treatment, and end of treatment. During the 12 weeks of treatment, each local skin reaction peaked at Week 2 and gradually reduced thereafter with the continued use of Tazarotene Foam.

Fabior

Indications

Contraindications

Warnings and precautions

5.1Fetal Risk

At a glance

Two medicines in one question?

Fabior

Indications

Contraindications

Warnings and precautions

5.1Fetal Risk

At a glance

Two medicines in one question?

5.2Local Irritation Tazarotene

5.3Potential Irritant Effect with Concomitant Topical Medications

5.4Photosensitivity and Risk for Sunburn Because

5.5Flammability

Interactions

Pregnancy and breastfeeding

8.1Pregnancy Tazarotene

Adverse reactions

6.1Clinical Trials Experience

Composition

Official product information