FABIOR (tazarotene)

Following topical application, tazarotene undergoes esterase hydrolysis to form its active metabolite, tazarotenic acid. Tazarotenic acid was highly bound to plasma proteins (greater than 99%). Tazarotene and tazarotenic acid were metabolized to sulfoxides, sulfones, and other polar metabolites which were eliminated through urinary and fecal pathways. Systemic exposure following topical application of FABIOR Foam 0.1% was evaluated in one trial. Patients aged 15 years and older with moderate-to-...

In 2 multi-center, randomized, double-blind, vehicle-controlled trials, a total of 1,485 subjects with moderate-to-severe acne vulgaris were randomized 1:1 to FABIOR Foam or vehicle applied once daily for 12 weeks. Acne severity was evaluated using lesion counts and the 6-point Investigator's Global Assessment (IGA) scale (see Table 2 ). At baseline, 80% of subjects were graded as "moderate" or Grade 3 and 20% were graded as "severe" or Grade 4 on the IGA scale. At baseline, subjects had an average of 79.8 total lesions of which the mean number of inflammatory lesions was 31.9 and the mean num...

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 6.1 Clinical 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 ...

FABIOR Foam is contraindicated in pregnancy. FABIOR 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) ]. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug,...

Fetal Risk: FABIOR Foam contains tazarotene, which is a teratogenic substance. FABIOR 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 Medicati...

7 DRUG INTERACTIONS No formal drug-drug interaction studies were conducted with FABIOR Foam. Concomitant dermatologic medications and cosmetics that have a strong drying effect should be avoided. It is recommended to postpone treatment until the effects of these products subside before use of FABIOR Foam is started. Concomitant use with oxidizing agents, such as benzoyl peroxide, may cause degrada...