Arazlo

ARAZLO- tazarotene lotion
Bausch Health US, LLC

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.

2 DOSAGE AND ADMINISTRATION

Apply a thin layer of ARAZLO to the affected areas once daily. Avoid the eyes, mouth, paranasal creases, and mucous membranes. If ARAZLO gets in or near eyes, rinse thoroughly with water.

ARAZLO is for topical use only. Not for oral, ophthalmic, or intravaginal use.

Wash hands thoroughly after applying ARAZLO.

Avoid concomitant use with oxidizing agents, such as benzoyl peroxide. If the concomitant use of ARAZLO with oxidizing agents is required, apply each at different times of the day (e.g. one in the morning and the other in the evening) [see Drug Interactions (7)].

Use effective sunscreens and wear protective clothing while using ARAZLO [see Warnings and Precautions (5.3)].

3 DOSAGE FORMS AND STRENGTHS

Lotion, 0.045%

Each gram of ARAZLO contains 0.45 mg (0.045%) tazarotene in a white to off-white topical lotion.

4 CONTRAINDICATIONS

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)].

5 WARNINGS AND PRECAUTIONS

5.1 Embryofetal Toxicity

Based on data from animal reproduction studies, retinoid pharmacology and the potential for systemic absorption, ARAZLO may cause fetal harm when administered to a pregnant patient and is contraindicated during pregnancy. Safety in pregnant patients has not been established. The potential risk to the fetus outweighs the potential benefit to the mother; therefore, discontinue ARAZLO as soon as pregnancy is recognized.

Tazarotene elicits malformations and developmental effects associated with retinoids after topical and oral administration to pregnant rats and rabbits during organogenesis. However, limited case reports of pregnancy in females enrolled in clinical trials for ARAZLO have not reported a clear association with tazarotene and major birth defects or miscarriage risk [see Contraindications (4), Use in Specific Populations (8.1)].

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 in animals, and it is not known what level of exposure is required for teratogenicity in humans.

Advise pregnant patients of the potential risk to a fetus. Obtain a pregnancy test within 2 weeks prior to ARAZLO therapy. Initiate ARAZLO therapy during a menstrual period. Advise patients of childbearing potential to use effective contraception during treatment with ARAZLO [see Dosage and Administration (2), Use in Specific Populations (8.3)].

5.2 Skin Irritation

Patients using ARAZLO may experience application site pain, dryness, exfoliation, erythema, and pruritus. Depending upon severity of these adverse reactions, instruct patients to use a moisturizer, reduce the frequency of the application of ARAZLO, or discontinue use. Therapy can be resumed, or the frequency of application can be increased, as the patient becomes able to tolerate treatment.

Avoid use of concomitant medications and cosmetics that have a strong drying effect. It is recommended to postpone treatment with ARAZLO until the drying effects of these products subside.

Avoid application of ARAZLO to eczematous or sunburned skin.

5.3 Photosensitivity and Risk for Sunburn

Because of heightened burning susceptibility, minimize unprotected exposure to ultraviolet light including sunlight and sunlamps during the use of ARAZLO. Warn patients who normally experience high levels of sun exposure and those with inherent sensitivity to sun to exercise caution. Use sunscreen products and protective clothing over treated areas when sun exposure cannot be avoided. Patients with sunburn should be advised not to use ARAZLO until fully recovered.

ARAZLO should be administered with caution if the patient is taking drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the increased possibility of augmented photosensitivity.

Weather extremes, such as wind or cold, may be more irritating to patients using ARAZLO.

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)]

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 defined as application site stinging, burning or pain

Application site 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%

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