ARAZLO

Following topical application, tazarotene undergoes esterase hydrolysis to form its active metabolite, tazarotenic acid. Tazarotenic acid is highly bound to plasma proteins (greater than 99%). Systemic exposure following topical application of ARAZLO was evaluated in 28 subjects in an open-label, randomized, pharmacokinetic study. Subjects aged 9 years and older with moderate to severe acne applied approximately 4 grams of ARAZLO to the entire face (excluding eyes and lips), neck, upper chest, u...

The safety and efficacy of once daily use of ARAZLO for the treatment of acne vulgaris were assessed in two multicenter, randomized, double-blind clinical trials in subjects 9 years and older with facial acne vulgaris. Enrolled subjects had a score of moderate (3) or severe (4) on the Evaluator’s Global Severity Score (EGSS), 20 to 50 inflammatory lesions (papules, pustules, and nodules), 25 to 100 non-inflammatory lesions (open and closed comedones) and two or fewer facial nodules. The majority of subjects were White (74%) and female (66%). Approximately 22% were Hispanic/Latino and 42% were ...

The following serious adverse reactions are discussed in more detail in other sections of the labeling: Embryofetal toxicity [see Warnings and Precautions (5.1) ] Photosensitivity and Risk of Sunburn [see Warnings and Precautions (5.3) ] The most common adverse reactions (occurring in ≥1% of the ARAZLO group and greater than the vehicle group) were application site reactions; pain, dryness, exfoliation, erythema and pruritus. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health U...

ARAZLO is contraindicated in pregnancy. ARAZLO may cause fetal harm when administered to a pregnant patient [see Warnings and Precautions (5.1) , Use in Specific Populations (8.1, 8.3) ] . ARAZLO is contraindicated in pregnancy. ( 4 , 8.1 )

Embryofetal Toxicity : May cause fetal harm when administered during pregnancy. Patients of childbearing potential should have a negative pregnancy test within 2 weeks prior to initiating treatment and use effective contraception during treatment. ( 5.1 ) Skin Irritation : Pain, dryness, exfoliation, erythema, and pruritus may occur with use of ARAZLO. Avoid application to eczematous or sunburned skin. ( 5.2 ) Photosensitivity and Risk for Sunburn : Minimize exposure to sunlight and sunlamps. Us...