Arazlo
Generic: TAZAROTENE
Basic Information
Manufacturer
Bausch Health US, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
d941ff25-c221-4a55-8012-0dcf3bbcbbd1
Indications & Usage
1 INDICATIONS AND USAGE ARAZLO ® (tazarotene) lotion, 0.045% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.
ARAZLO is a retinoid indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.
( 1 )
ARAZLO is a retinoid indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.
( 1 )
Adverse Reactions
6 ADVERSE REACTIONS 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 US, LLC at 1-800-321-4576 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 compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
In 2 multicenter, randomized, double-blind, vehicle-controlled clinical trials, subjects age 9 years and older applied ARAZLO or vehicle once daily for 12 weeks.
The majority of subjects were White (74%) and female (66%).
Approximately 22% were Hispanic/Latino and 42% were younger than 18 years of age, fourteen of 779 subjects (1.8%) treated with ARAZLO were between 9 years to less than 12 years of age.
Adverse reactions reported by ≥1% of subjects treated with ARAZLO and more frequently than subjects treated with vehicle are summarized in Table 1.
Most adverse reactions were mild to moderate in severity.
Severe adverse reactions represented 1.3% of the subjects treated.
Overall, 2.4% (19/779) of subjects discontinued ARAZLO because of local skin reactions.
Table 1:Adverse Reactions Reported by ≥1% of the ARAZLO Group and More Frequently than the Vehicle Group Adverse Reactions N (%) ARAZLO N=779 Vehicle N=791 Application site pain Application site pain defined as application site stinging, burning or pain 41 (5) 2 (<1) Application site dryness 30 (4) 1 (<1) Application site exfoliation 16 (2) 0 (0) Application site erythema 15 (2) 0 (0) Application site pruritus 10 (1) 0 (0) Skin irritation was evaluated by active assessment of erythema, scaling, itching, burning and stinging, with grades for none, mild, moderate, or severe.
The maximum severity generally peaked at Week 2 of therapy and decreased thereafter.
The percentage of subjects with these signs and symptoms at any post-baseline visit are summarized in Table 2.
Table 2: Incidence of Local Cutaneous Irritation at any Post-Baseline Visit ARAZLO Lotion N=774 Mild/Moderate/Severe Vehicle Lotion N=789 Mild/Moderate/Severe Erythema 49% 38% Scaling 51% 23% Itching 29% 14% Burning 30% 6% Stinging 22% 5%
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 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 compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
In 2 multicenter, randomized, double-blind, vehicle-controlled clinical trials, subjects age 9 years and older applied ARAZLO or vehicle once daily for 12 weeks.
The majority of subjects were White (74%) and female (66%).
Approximately 22% were Hispanic/Latino and 42% were younger than 18 years of age, fourteen of 779 subjects (1.8%) treated with ARAZLO were between 9 years to less than 12 years of age.
Adverse reactions reported by ≥1% of subjects treated with ARAZLO and more frequently than subjects treated with vehicle are summarized in Table 1.
Most adverse reactions were mild to moderate in severity.
Severe adverse reactions represented 1.3% of the subjects treated.
Overall, 2.4% (19/779) of subjects discontinued ARAZLO because of local skin reactions.
Table 1:Adverse Reactions Reported by ≥1% of the ARAZLO Group and More Frequently than the Vehicle Group Adverse Reactions N (%) ARAZLO N=779 Vehicle N=791 Application site pain Application site pain defined as application site stinging, burning or pain 41 (5) 2 (<1) Application site dryness 30 (4) 1 (<1) Application site exfoliation 16 (2) 0 (0) Application site erythema 15 (2) 0 (0) Application site pruritus 10 (1) 0 (0) Skin irritation was evaluated by active assessment of erythema, scaling, itching, burning and stinging, with grades for none, mild, moderate, or severe.
The maximum severity generally peaked at Week 2 of therapy and decreased thereafter.
The percentage of subjects with these signs and symptoms at any post-baseline visit are summarized in Table 2.
Table 2: Incidence of Local Cutaneous Irritation at any Post-Baseline Visit ARAZLO Lotion N=774 Mild/Moderate/Severe Vehicle Lotion N=789 Mild/Moderate/Severe Erythema 49% 38% Scaling 51% 23% Itching 29% 14% Burning 30% 6% Stinging 22% 5%