Tazarotene

Pharmacologic Category

Acne Products; Keratolytic Agent; Retinoic Acid Derivative; Topical Skin Product, Acne

Dosing: Adult

Note: In patients experiencing excessive pruritus, burning, skin redness, or peeling, discontinue until integrity of the skin is restored, or reduce dosing to an interval the patient is able to tolerate.

Acne: Topical:

Arazlo: Apply a thin layer to affected area once daily.

Fabior: Apply a small amount to affected area once daily in the evening.

Tazorac cream/gel 0.1%: Apply a thin layer (2 mg/cm2) to affected area once daily in the evening.

Palliation of fine facial wrinkles, facial mottled hyper-/hypopigmentation, benign facial lentigines: Topical: Avage: Apply a pea-sized amount to entire face once daily at bedtime.

Psoriasis: Topical: Tazorac cream/gel: Initial: 0.05%: Apply once daily to psoriatic lesions using enough (2 mg/cm2) to cover only the lesion with a thin film. May increase strength to 0.1% if tolerated and necessary.

* See Dosage and Administration in AHFS Essentials for additional information.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Pediatric

Note: In patients experiencing excessive pruritus, burning, skin redness, or peeling, discontinue until integrity of the skin is restored or reduce dosing to an interval the patient is able to tolerate.

Acne vulgaris:

Cream or gel: Children ≥12 years and Adolescents: Topical: Tazorac (0.1%): Apply as a thin film (2 mg/cm2) to affected area(s) once daily in the evening.

Foam: Children ≥12 years and Adolescents: Topical: Fabior (0.1%): Apply a small amount to affected area(s) once daily in the evening.

Lotion: Children ≥9 years and Adolescents: Topical: Arazlo (0.045%): Apply a thin layer to affected area(s) once daily.

Psoriasis:

Cream: Adolescents ≥18 years: Topical: Tazorac (0.05%): Initial: Apply a thin film (2 mg/cm2) to affected area once daily in the evening; may increase strength to 0.1% if tolerated and necessary.

Gel: Children ≥12 years and Adolescents: Topical: Tazorac (0.05%): Initial: Apply a thin film (2 mg/cm2) to affected area once daily in the evening; may increase strength to 0.1% if tolerated and necessary; apply to no more than 20% of the body surface area.

Palliation of fine facial wrinkles, facial mottled hyper-/hypopigmentation, benign facial lentigines: Adolescents ≥17 years: Topical: Cream: Avage (0.1%): Apply a pea-sized amount once daily at bedtime; lightly cover entire face including eyelids if desired.

Dosing: Renal Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely necessary due to low systemic absorption.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely necessary due to low systemic absorption.

Use: Labeled Indications

Acne (Arazlo 0.045% lotion, Fabior, Tazorac 0.1% cream, Tazorac 0.1% gel): Topical treatment of acne vulgaris in patients ≥9 years of age (Arazlo) or ≥12 years of age.

Palliation of fine facial wrinkles, facial mottled hyper-/hypopigmentation, benign facial lentigines (Avage): Adjunctive agent for use in the mitigation (palliation) of facial fine wrinkling, facial mottled hyper- and hypopigmentation, and benign facial lentigines in patients ≥17 years of age who use comprehensive skin care and sunlight avoidance programs.

Psoriasis:

Tazorac 0.05% and 0.1% cream: Topical treatment of plaque psoriasis in patients ≥18 years of age.

Tazorac 0.05% and 0.1% gel: Topical treatment of stable plaque psoriasis of up to 20% body surface area involvement in patients ≥12 years of age.

Limitations of use: Does not eliminate or prevent wrinkles, repair sun-damaged skin, reverse photoaging, or restore more youthful or younger skin. Has not demonstrated a mitigating effect on significant signs of chronic sunlight exposure such as coarse or deep wrinkling, tactile roughness, telangiectasia, skin laxity, keratinocytic atypia, melanocytic atypia, or dermal elastosis. Safety and effectiveness for the prevention or treatment of actinic keratoses, skin neoplasms, or lentigo maligna has not been established. Safe and effective daily use >52 weeks is not known. Safety of gel use on more than 20% body surface area has not been established.

* See Uses in AHFS Essentials for additional information.

Clinical Practice Guidelines

Acne:

American Academy of Dermatology, "Guidelines of care for the management of acne vulgaris," May 2016

Administration: Topical

For topical use only; not for oral, ophthalmic, or intravaginal use. Avoid eyes, mouth, paranasal creases, or other mucous membranes; rinse thoroughly with water if contact occurs. Do not cover treated areas with dressings or bandages. Do not apply to eczematous, abraded, broken, or sunburned skin. Use effective sunscreen and wear protective clothing during treatment. Wash hands after use.

Acne: Apply in evening after gently cleansing and drying face; apply enough to cover entire affected area.

Foam: Dispense a small amount of foam into palm of the hand. Use fingertips to lightly cover the entire affected area of the face and/or upper trunk with a thin layer; massage into skin until foam disappears. Moisturizer may be used if necessary.

Palliation of fine facial wrinkles, facial mottled hyper-/hypopigmentation, benign facial lentigines: Apply to clean dry face at bedtime; lightly cover entire face including eyelids if desired. Emollients or moisturizers may be applied before or after; ensure first cream or lotion has absorbed into the skin and has dried completely before applying tazarotene.

Psoriasis: Apply in evening. If a bath or shower is taken prior to application, dry the skin before applying. If emollients are used, apply them at least 1 hour prior to application. Unaffected skin may be more susceptible to irritation, avoid application to these areas.

Administration: Pediatric

For topical use only; not for oral, ophthalmic, or intravaginal use. Avoid eyes, mouth, or other mucous membranes; rinse thoroughly with water if contact occurs. Do not cover treated areas with dressings or bandages. Do not apply to eczematous, abraded, broken, or sunburned skin. Use effective sunscreen and wear protective clothing during treatment. Wash hands after use.

Acne:

Cream (Tazorac), foam, gel: Apply in evening after gently cleansing and drying face; apply enough to cover entire affected area.

Foam: Wash with a mild cleanser and dry affected area before applying foam. Shake can before use then dispense a small amount of foam into palm of the hand. Use fingertips to lightly cover the entire affected area of the face and/or upper trunk with a thin layer; massage into skin until foam disappears. Moisturizer may be used if necessary.

Lotion: Apply thin layer to cover affected area.

Palliation of fine facial wrinkles, facial mottled hyper-/hypopigmentation, benign facial lentigines: Cream (Avage): Apply to clean, dry face at bedtime; lightly cover entire face including eyelids if desired. Emollients or moisturizers may be applied before or after; if applied before tazarotene, ensure cream or lotion has absorbed into the skin and has dried completely before applying tazarotene.

Psoriasis: Cream (Tazorac), gel: Apply in evening. If a bath or shower is taken prior to application, dry the skin before applying. If emollients are used, apply them at least 1 hour prior to application. Unaffected skin may be more susceptible to irritation; avoid application to these areas.

Storage/Stability

Cream: Store at 25°C (77°F); excursions are permitted between -5°C to 30°C (23°F to 86°F).

Foam: Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C to 30°C (59°F to 86°F). Store upright and protect from freezing. Foam is flammable; avoid fire, flame, or smoking during and immediately following application. Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperatures above 49°C (120°F).

Gel: Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C to 30°C (59°F to 86°F).

Lotion: Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C to 30°C (59°F to 86°F); protect from freezing.

Medication Patient Education with HCAHPS Considerations

What is this drug used for?

• It is used to treat pimples (acne).

• It is used to treat plaque psoriasis.

• It is used to lower the number of wrinkles and liver spots.

• It may be given to you for other reasons. Talk with the doctor.

Frequently reported side effects of this drug

• Dry skin

• Stinging

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

• Sunburn

• Swelling

• Peeling

• Redness

• Burning

• Itching

• Skin irritation

• Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Contraindications

Hypersensitivity to tazarotene or any component of the formulation; women who are or may become pregnant

Documentation of allergenic cross-reactivity for retinoids is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Warnings/Precautions

Concerns related to adverse effects:

• Photosensitivity: May cause photosensitivity; exposure to ultraviolet rays (including sunlight/sunlamps) should be avoided unless deemed medically necessary, and in such cases, exposure should be minimized. Risk may be increased by concurrent therapy with known photosensitizers (thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides); use with caution. Use with caution in patients with a personal or family history of skin cancer. Daily sunscreen use and other protective measures recommended. Patients with sunburn should discontinue use until sunburn has healed.

• Skin irritation: Local tolerability reactions (including blistering or skin desquamation) or local hypersensitivity reactions (including urticaria) may occur. Application-site pain, excessive burning, drying, pruritus, peeling, and skin redness may occur, especially during the early weeks of treatment. Treatment can increase skin sensitivity to weather extremes of wind or cold. Concomitant topical medications (eg, medicated or abrasive soaps, cleansers, cosmetics with a strong drying effect) should be avoided due to increased skin irritation. Depending on the severity of the reaction, instruct patients to use a moisturizer, reduce the frequency of use, or discontinue use.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer's labeling.

• Foam: Propellant is flammable; avoid fire and smoking during and immediately after use.

• Gel: Safety and efficacy of gel applied over >20% of BSA have not been established.

Other warnings/precautions:

• Appropriate use: For external use only; avoid contact with eyes, eyelids, and mouth. Not for use on eczematous, abraded, broken, or sunburned skin; not for treatment of lentigo maligna. Avoid application over extensive areas. The efficacy of tazarotene gel in the treatment of acne previously treated with other retinoids or resistant to oral antibiotics has not been established.

* See Cautions in AHFS Essentials for additional information.

Geriatric Considerations

No differences in safety or efficacy were seen when the cream formulation was administered to patients >65 years of age; may experience increased sensitivity. Increased incidence of adverse effects and lower treatment success rates were observed with the gel formulation in the treatment of psoriasis.

Reproductive Considerations

Evaluate pregnancy status prior to use in females of reproductive potential. A negative pregnancy test should be obtained within 2 weeks prior to treatment; treatment should begin during a normal menstrual period. Adequate contraception should be used in females of reproductive potential.

Pregnancy Considerations

Use in pregnancy is contraindicated.

Inadvertent exposure to a limited number of pregnant women occurred during premarketing studies; however, the available data are inadequate to evaluate outcomes. Based on data from animal reproduction studies, retinoid pharmacology, and the potential for systemic absorption, in utero exposure to tazarotene may cause fetal harm.

Topical products are recommended as initial therapy for the treatment of acne or psoriasis in pregnant women. Because the safety of tazarotene is uncertain, use during pregnancy is contraindicated (Bae 2012; Chien 2016; Kong 2013).

Breast-Feeding Considerations

It is not known if tazarotene is present in breast milk.

Systemic absorption depends on formulation and size of surface area. In general, the use of topical agents is preferred over systemic agents for the treatment of facial acne and psoriasis in females who are breastfeeding. Avoid applying large amounts over prolonged periods of time to decrease the potential for systemic absorption (Butler 2014; Kong 2013; Kurizky 2015; Leachman 2006). When treatment with tazarotene is needed in breastfeeding females, application area should be <20% of body surface area (Butler 2014). Topical psoriasis agents needed in the chest area should be applied after breastfeeding and removed prior to the next session (Kurizky 2015).

Briggs' Drugs in Pregnancy & Lactation

• Tazarotene

Adverse Reactions

Percentage of incidence varies with formulation and/or strength:

>10%: Dermatologic: Desquamation (0.1% cream 40%; foam 6%), erythema (0.1% cream 34%; foam 6%), burning sensation of skin (26%), xeroderma (7% to 16%), skin irritation (10% to 14%), exacerbation of psoriasis, skin pain

1% to 10%:

Cardiovascular: Peripheral edema

Dermatologic: Pruritus (0.1% cream 10%; foam 1%), contact dermatitis (8%), stinging of the skin (3%), skin rash (≤3%), cheilitis (1%), dermatitis (1%), skin photosensitivity (1%), eczema, skin discoloration, skin fissure

Endocrine & metabolic: Hypertriglyceridemia

Local: Application site pain (1%), local hemorrhage

Ophthalmic: Ocular irritation (including edema, irritation, and inflammation of the eye or eyelid; 4%)

Frequency not defined: Hypersensitivity: Hypersensitivity reaction, local hypersensitivity reaction

<1%, postmarketing, and/or case reports: Application site edema, exfoliation of skin, impetigo, pain, skin blister

* See Cautions in AHFS Essentials for additional information.

Allergy and Idiosyncratic Reactions

• Retinoid Allergy

Metabolism/Transport Effects

None known.

Drug Interactions Open Interactions

There are no known significant interactions.

Monitoring Parameters

Disease severity in plaque psoriasis during therapy (reduction in erythema, scaling, induration); clinical response and skin tolerance. Evaluate pregnancy status prior to use in females of reproductive potential.

Advanced Practitioners Physical Assessment/Monitoring

Verify that female patients of childbearing age are not pregnant. Ensure proper use of birth control prior to therapy. Assess skin integrity and effectiveness of therapy. Assess for accumulated photosensitivity.

Nursing Physical Assessment/Monitoring

Check pregnancy status and educate patients of childbearing age on the importance of not becoming pregnant and reliable birth control while on this medicine. Monitor skin integrity and effectiveness of therapy. Assess for accumulated photosensitivity.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Cream, External:

Avage: 0.1% (30 g [DSC]) [contains benzyl alcohol]

Tazorac: 0.05% (30 g [DSC], 60 g [DSC]) [contains benzyl alcohol]

Tazorac: 0.05% (30 g, 60 g) [contains benzyl alcohol, edetate disodium]

Tazorac: 0.1% (30 g, 60 g [DSC]) [contains benzyl alcohol]

Tazorac: 0.1% (60 g) [contains benzyl alcohol, edetate disodium]

Generic: 0.1% (30 g, 60 g)

Foam, External:

Fabior: 0.1% (50 g, 100 g)

Gel, External:

Tazorac: 0.05% (30 g, 100 g); 0.1% (30 g, 100 g [DSC]) [contains benzyl alcohol]

Tazorac: 0.1% (100 g) [contains benzyl alcohol, edetate disodium]

Lotion, External:

Arazlo: 0.045% (45 g) [contains edetate disodium dihydrate, methylparaben, propylparaben]

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Cream, External:

Tazorac: 0.05% (3.5 g, 30 g); 0.1% (3.5 g, 30 g) [contains benzyl alcohol]

Gel, External:

Tazorac: 0.05% (3.5 g, 30 g); 0.1% (3.5 g, 30 g)

Anatomic Therapeutic Chemical (ATC) Classification

• D05AX05

Generic Available (US)

May be product dependent

Pricing: US

Cream (Tazarotene External)

0.1% (per gram): $12.99 - $13.01

Cream (Tazorac External)

0.05% (per gram): $16.74

0.1% (per gram): $17.78

Foam (Fabior External)

0.1% (per gram): $13.87

Gel (Tazorac External)

0.05% (per gram): $16.74

0.1% (per gram): $17.78

Lotion (Arazlo External)

0.045% (per gram): $12.00

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

Synthetic, acetylenic retinoid which modulates differentiation and proliferation of epithelial tissue and exerts some degree of anti-inflammatory and immunological activity

Pharmacodynamics/Kinetics

Onset of action: Psoriasis: 1 week

Duration: Therapeutic: Psoriasis: Effects have been observed for up to 3 months after a 3-month course of topical treatment

Absorption: Minimal following cutaneous application (≤6% of dose)

Distribution: Retained in skin for prolonged periods after topical application

Protein binding: >99% (tazarotenic acid)

Metabolism: Prodrug, rapidly metabolized via esterase hydrolysis to an active metabolite (tazarotenic acid) following topical application and systemic absorption; tazarotenic acid undergoes further hepatic metabolism

Half-life elimination:

Cream, gel: ~18 hours (tazarotenic acid)

Foam: 8.1 ± 3.7 hours

Excretion: Urine and feces (as metabolites)

Pharmacodynamics/Kinetics: Additional Considerations

Pediatric: Arazlo: In patients 9 to <12 years of age, mean tazarotenic acid Cmax is ~2.4-fold higher and mean AUC (0-t) is ~2.3-fold higher compared to patients ≥12 years of age.

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

No significant effects or complications reported

Effects on Bleeding

No information available to require special precautions

FDA Approval Date

June 13, 1997

References

Ahlfors CE. Benzyl alcohol, kernicterus, and unbound bilirubin. J Pediatr. 2001;139(2):317-319.[PubMed 11487763]

Arazlo (tazarotene) [prescribing information]. Bridgewater, NJ: Bausch Health US. LLC; December 2019.

Avage (tazarotene) [prescribing information]. Irvine, CA: Allergan, Inc; July 2017.

Bae YS, Van Voorhees AS, Hsu S, et al; National Psoriasis Foundation. Review of treatment options for psoriasis in pregnant or lactating women: from the Medical Board of the National Psoriasis Foundation. J Am Acad Dermatol. 2012;67(3):459-477. doi: 10.1016/j.jaad.2011.07.039.[PubMed 22018758]

Butler DC, Heller MM, Murase JE. Safety of dermatologic medications in pregnancy and lactation: Part II. Lactation. J Am Acad Dermatol. 2014;70(3):417.e1-e10; quiz 427. doi: 10.1016/j.jaad.2013.09.009.[PubMed 24528912]

Centers for Disease Control (CDC). Neonatal deaths associated with use of benzyl alcohol—United States. MMWR Morb Mortal Wkly Rep. 1982;31(22):290-291. http://www.cdc.gov/mmwr/preview/mmwrhtml/00001109.htm[PubMed 6810084]

Chien AL, Qi J, Rainer B, Sachs DL, Helfrich YR. Treatment of acne in pregnancy. J Am Board Fam Med. 2016;29(2):254-262. doi: 10.3122/jabfm.2016.02.150165.[PubMed 26957383]

Fabior (tazarotene) [prescribing information]. Greenville, NC: Mayne Pharma; June 2018.

"Inactive" ingredients in pharmaceutical products: update (subject review). American Academy of Pediatrics (AAP) Committee on Drugs. Pediatrics. 1997;99(2):268-278.[PubMed 9024461]

Kong YL, Tey HL. Treatment of acne vulgaris during pregnancy and lactation. Drugs. 2013;73(8):779-787. doi: 10.1007/s40265-013-0060-0.[PubMed 23657872]

Kurizky PS, Ferreira Cde C, Nogueira LS, Mota LM. Treatment of psoriasis and psoriatic arthritis during pregnancy and breastfeeding. An Bras Dermatol. 2015;90(3):367-375. doi: 10.1590/abd1806-4841.20153113.[PubMed 26131868]

Leachman SA, Reed BR. The use of dermatologic drugs in pregnancy and lactation. Dermatol Clin. 2006;24(2):167-197, vi. doi: 10.1016/j.det.2006.01.001.[PubMed 16677965]

Tazorac cream (tazarotene) [prescribing information]. Exton, PA: Almirall, LLC; August 2019.

Tazorac cream (tazarotene) [product monograph]. Markham, Ontario, Canada: Allergan Inc; December 2015.

Tazorac gel (tazarotene) [prescribing information]. Exton, PA: Almirall, LLC; August 2019.

Tazorac gel (tazarotene) [product monograph]. Markham, Ontario, Canada: Allergan Inc; June 2015.

Brand Names: International

Acniswab (EG); Aguder (CL); Avage (NZ, SG); Evitar (SA); Ful Lee (TW); Glentaz (VN); Le Wei (CN); Marzoten (CR, DO, GT, HN, NI, PA, SV); Psorix Gel (BD); Pzoret (CO); Que Wei (CN); Rantric (CO); Regava (EG); Soritene (BD); Sumaytene (TW); Suretin (CH, IT, MX); Tarac (TW); Tazaro (EG); Tazmeral (CR, DO, GT, HN, NI, PA, SV); Tazoderm Forte (IN); Tazorac (CZ); Tazoskin (BD); Tazoten (TW); Tazret (PH); Zaroten (BD); Zarotex (EG); Zorac (AT, AU, BE, BG, BR, DE, ES, FR, GB, GR, HR, IT, NZ, PL, SE)

Last Updated 5/7/20