OPEN-LABEL TRUNCAL STUDY

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OPEN-LABEL TRUNCAL STUDY

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Tazarotene triggers

a range of activities in the skin1,2

 

Rapid conversion

Tazarotene is a retinoid prodrug that is rapidly metabolized to its pharmacologically active form, tazarotenic acid1,2

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Preferential activation

Binds to retinoic acid receptors RARα, RARβ and RARγ, but shows relative selectivity for RARβ, and RARγ and may modify gene expression. Tazarotene upregulates tazarotene-induced genes, TIG-1, TIG-2, and TIG-3.1,2

The clinical significance of these findings for the treatment of acne vulgaris is unknown.

TAZAROTENE MECHANISM OF ACTION MAY INCLUDE2:

  • Mediating an antiproliferative effect
  • Normalizing keratinocyte differentiation
  • Downregulating markers of inflammation

The mechanism of tazarotene action in acne is not defined.

Indication

ARAZLO® (tazarotene) Lotion, 0.045% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.

Important Safety Information

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

Contraindication

ARAZLO Lotion is contraindicated in pregnancy due to the potential harm to the fetus.

Warnings and Precautions

Embryofetal Risk Females of childbearing potential should be warned of the potential risk and use adequate birth-control measures when ARAZLO Lotion is used. A negative result for pregnancy should be obtained within 2 weeks prior to ARAZLO Lotion therapy. ARAZLO Lotion therapy should begin during a menstrual period.

Skin Irritation Patients using ARAZLO Lotion 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 Lotion, or discontinue use. Therapy can be resumed, or the frequency of application can be increased, as the patient becomes able to tolerate treatment. Avoid application of ARAZLO Lotion to eczematous or sunburned skin.

Ultraviolet Light and Environmental Exposure Minimize unprotected exposure to ultraviolet light, including sunlight and sunlamps, during the use of ARAZLO Lotion. 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. ARAZLO Lotion should be administered with caution if the patient is also taking drugs known to be photosensitizers (eg, 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 Lotion.

Adverse Reactions The most common adverse reactions (in ≥1% of patients and greater than vehicle) were: pain, dryness, exfoliation, erythema, and pruritus (all at application site).

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. Please click here for full Prescribing Information.

References: 1. ARAZLO Lotion [prescribing information]. Bridgewater, NJ. Bausch Health US, LLC. 2. Tanghetti EA, Kircik LH, Green LJ, et al. A phase 2, multicenter, double-blind, randomized, vehicle-controlled clinical study to compare the safety and efficacy of a novel tazarotene 0.045% lotion and tazarotene 0.1% cream in the treatment of moderate-to-severe acne vulgaris. J Drugs Dermatol. 2019;18(6):542-548. 3. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm. Accessed October 10, 2019. 4. Data on file.

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