tazarotene (Rx)

Brand and Other Names:Avage, Tazorac, more...Fabior, Arazlo
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

cream, topical

  • 0.1% (Avage, Tazorac, generic)

gel, topical

  • 0.05% (Tazorac, generic)
  • 0.1% (Tazorac, generic)

foam, topical

  • 0.1% (Fabior)

lotion, topical

  • 0.045% (Arazlo)

Acne Vulgaris

Tazorac, Fabior, Arazlo

  • Cream 0.1% indicated for acne vulgaris and gel 0.1% indicated for mild-to-moderate acne vulgaris; whereas, foam 0.1% indicated for moderate-to-severe acne
  • Cream/gel/foam 0.1%: Apply to affected area qDay
  • Lotion 0.045%: Apply thin layer to affected areas qDay

Psoriasis

Tazorac

  • Indicated for topical treatment of stable plaque psoriasis; gel indicated for up to 20% body surface area (BSA)
  • Cream/gel 0.05% or 0.1%: apply to affected area qDay

Wrinkles

Avage

  • Indicated to mitigate signs of chronic sunlight exposure (eg, coarse or deep wrinkling, tactile roughness, telangiectasia, skin laxity, keratinocytic atypia, melanocytic atypia, dermal elastosis)
  • Apply to affected areas qHS

Dosing Considerations

Limitations of use

  • Efficacy in the treatment of acne previously treated with other retinoids or resistant to oral antibiotics has not been established
  • Tazorac gel: Safety of use on more than 20% BSA has not been established
  • Avage
    • Safety and effectiveness for prevention or treatment of actinic keratoses, skin neoplasms, or lentigo maligna have not been established
    • Does not eliminate or prevent wrinkles or restore more youthful skin
    • Does not repair sun-damaged skin or reverse photoaging

Dosage Forms & Strengths

cream, topical

  • 0.1% (Tazorac, generic)

gel, topical

  • 0.05% (Tazorac, generic)
  • 0.1% (Tazorac, generic)

foam, topical

  • 0.1% (Fabior)

lotion, topical

  • 0.045% (Arazlo)

Acne Vulgaris

Tazorac or Fabior

  • Cream 0.1% indicated for acne vulgaris and gel 0.1% indicated for mild-to-moderate acne vulgaris; whereas, foam 0.1% indicated for moderate-to-severe acne
  • <12 years: Safety and efficacy not established
  • ≥12 years: Apply to affected area qDay

Arazlo

  • Lotion 0.045% indicated for acne vulgaris
  • <9 years: Safety and efficacy not established
  • ≥9 years: Apply to affected area qDay

Psoriasis

Cream indicated for topical treatment of stable plaque psoriasis; gel indicated for up to 20% BSA

<12 years: Safety and efficacy not established

≥12 years: Apply to affected area qDay

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Adverse Effects

>10%

Scaling (51%)

Erythema (34-49%)

Desquamation (40%)

Burning/stinging (22-30%)

Itching (29%)

Dry skin (15%)

1-10%

Skin irritation (10%)

Pruritus (10%)

Irritant contact dermatitis (8%)

Stinging (3%)

Rash (3%)

Cheilitis (1%)

Arazlo

  • Application site pain (5%)
  • Application site dryness (4%)
  • Application site exfoliation (2%)
  • Application site erythema (2%)
  • Application site pruritus (1%)

Frequency Not Defined

Worsening of psoriasis

Eczema

Rash

Dry skin

Skin inflammation

Fissuring

Bleeding

Peripheral edema

Hypertriglyceridemia

Postmarketing Reports

Blister, rash, skin discoloration (including skin hyperpigmentation or skin hypopigmentation), and pain

Embryofetal toxicity

Photosensitivity and risk of sunburn

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Warnings

Contraindications

Pregnancy

Hypersensitivity

Cautions

Propellant in foam is flammable; avoid fire, flame, and/or smoking during and immediately following application

Local irritation

  • Excessive irritation in skin of certain sensitive individuals; local reactions (including blistering and skin desquamation, pruritus, burning, erythema)and hypersensitivity adverse reactions (including urticaria) reported with topical application
  • If adverse reactions occur, consider discontinuing the medication or reducing dosing frequency, as appropriate, until integrity of skin is restored; alternatively, patients withpsoriasis who are being treated with 0.1% concentration can be switched to lower concentration; frequency of application should be closely monitored by careful observation of clinical therapeutic response and skin tolerance; therapy can be resumed, or drug concentrationor frequency of application can be increased as patient becomes able to tolerate treatment
  • Concomitant topical medications and cosmetics that have strong drying effect should be avoided; it is also advisable to "rest" a patient's skin until effects of such preparations subside before treatment is initiated
  • Drug should not be used on eczematous skin, as it may cause severe irritation
  • Weather extremes, such as wind or cold, may be more irritating to patients using the topical application

Photosensitivity and risk of sunburn

  • Because of heightened burning susceptibility, exposure to sunlight (including sunlamps) should be avoided unless deemed medically necessary, and in such cases, exposure should be minimized during therapy
  • Patients must be warned to use sunscreens and protective clothing when using this drug; patients with sunburn should be advised not to use the topical application until fully recovered; patients who may have considerable sun exposure due to their occupation and those patients with inherent sensitivity to sunlight should exercise particular caution when using this drug
  • Administer with caution if patient is taking drugs known to be photosensitizers (eg, thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides)because of increased possibility of augmented photosensitivity
  • Use of sunscreens (minimum strength of SPF 15) and protective clothing recommended during use

Embryofetal toxicity

  • This drug elicits malformations and developmental effects associated with retinoids after topical and oral administration to pregnant rats and rabbits during organogenesis; systemic exposure to tazarotenic acid is dependent upon extent of body surface area treated; in patients treated topically over sufficient body surface area, exposure could be in same order of magnitude as in orally treated animals
  • Although there may be less systemic exposure in treatment of acne of the face alone due to less surface area for application, this drug is a teratogenic substance and causes fetal malformations in animals, and it is not known what level of exposure is required for teratogenicity in humans

Drug interaction overview

  • Concomitant topical acne therapy should be used with caution because a cumulative irritant effect may occur; if irritancy or dermatitis occurs, reduce frequency of application or temporarily interrupt treatment and resume once the irritation subsides
  • Avoid concomitant dermatologic medications and cosmetics that have a strong drying effect; postpone treatment until the effects of these products subside before initiating treatment
  • Coadministration with oxidizing agents, such as benzoyl peroxide, may cause degradation of tazarotene and may reduce the clinical efficacy of tazarotene; if combination therapy is required, apply at different times of the day (eg, one in the morning and the other in the evening).
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Pregnancy & Lactation

Pregnancy

There are no adequate and well-controlled studies with use in pregnant women

Contraindicated in females who are or may become pregnant

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

Females of childbearing potential

  • Females of child-bearing potential should be warned of potential risk and use adequate birth- control measures when the drug is administered; the possibility that a female of child-bearing potential is pregnant at time of institution of therapy should be considered
  • Pregnancy testing
    • Pregnancy testing is recommended within 2 weeks before initiating therapy, which should begin during a menstrual period
  • Contraception
    • Based on animal studies, fetal harm may occur when administered to a pregnant woman
    • Advise to use effective contraception during treatment

Lactation

Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed child from therapy or from the underlying maternal condition

Clinical considerations

  • To minimize potential exposure to the breastfed infant via breast milk, use for the shortest duration possible while breastfeeding
  • Advise breastfeeding patients not to apply directly to the nipple and areola to prevent direct infant exposure

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Mechanism of Action

Retinoid: Appears to affect expression of genes that modulate cell (eg, epidermal) differentiation, proliferation, and inflammation, leading to normalization of keratinocyte differentiation and a reduction in cellular hyperproliferation and inflammation

Absorption

<1% systemically absorbed

Peak plasma concentration: 0.43 ng/mL (foam); 0.71 ng/ mL (gel); 0.236 ng/mL (0.1% cream)

Peak plasma time: 6 hr (foam); 9 hr (gel)

AUC: 6.98 ng⋅hr/mL (foam); 10.1 ng⋅hr/mL (gel); 1.38 ng⋅hr/mL (0.1% cream)

Steady-state within 22 days

Distribution

Protein bound: >99%

Metabolism

Hydrolyzed to its active metabolite, tazarotenic acid

Elimination

Half-Life: 8.1 hr (foam); ~18 hr (gel and cream)

Sulfoxides, sulfones, and other polar metabolites eliminated through urinary and fecal pathways

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Administration

Topical Administration

Not for ophthalmic, oral, or intravaginal use

Avoid the eyes, mouth, paranasal creases, and mucous membranes

If contact with eyes occurs, rinse thoroughly with water

Use effective sunscreens and wear protective clothing during use

Foam

  • Apply after washing with a mild cleanser and fully drying the affected area
  • Dispense a small amount of foam into the palm of the hand
  • Using fingertips, apply only enough foam to lightly cover the entire affected areas of the face and/or upper trunk with a thin layer; gently massage the foam into the skin until the foam disappears
  • Avoid eyes, lips, and mucous membranes
  • Wash hands after application
  • Use moisturizer as needed
  • If undue irritation (redness, peeling, or discomfort) occurs, reduce frequency of application or temporarily interrupt treatment
  • Resume once irritation subsides; discontinue if irritation persists

Lotion

  • Topical use only
  • Apply a thin layer to the affected areas
  • If lotion gets in or near eyes, rinse thoroughly with water
  • Wash hands thoroughly after applying lotion

Gel

  • Apply a thin film to cover only the psoriatic lesions on no more than 20% of BSA
  • If a bath or shower is taken before application, skin should be dry before applying the gel
  • If emollients are used, apply at least 1 hour before application
  • Because unaffected skin may be more susceptible to irritation, carefully avoid application of tazarotene

Storage

Gel and foam: Store at 20-25ºC (68-77ºF); excursions permitted from 15-30ºC (59-86ºF)

Tazorac cream: Store at 20-25ºC (68-77ºF); excursions permitted from -5-30ºC (23-86ºF)

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Images

BRAND FORM. UNIT PRICE PILL IMAGE
Arazlo topical
-
0.045 % lotion
tazarotene topical
-
0.1 % cream
tazarotene topical
-
0.1 % cream
tazarotene topical
-
0.1 % cream
tazarotene topical
-
0.1 % cream
tazarotene topical
-
0.1 % cream
Tazorac topical
-
0.1 % gel
Tazorac topical
-
0.05 % cream
Tazorac topical
-
0.1 % gel
Tazorac topical
-
0.05 % cream
Tazorac topical
-
0.1 % gel
Tazorac topical
-
0.1 % cream
Tazorac topical
-
0.1 % cream
Tazorac topical
-
0.05 % cream
Tazorac topical
-
0.05 % gel
Tazorac topical
-
0.05 % gel
Fabior topical
-
0.1 % foam
Fabior topical
-
0.1 % foam

Copyright © 2010 First DataBank, Inc.

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Patient Handout

Patient Education
tazarotene topical

TAZAROTENE - TOPICAL

(taz-AR-oh-teen)

COMMON BRAND NAME(S): Arazlo, Fabior, Tazorac

USES: This medication is used to treat certain skin conditions, including psoriasis and acne. Different brands, dosage forms, and strengths are approved for different uses, so be sure to check the uses for your brand, dosage form, and strength of this medication. Tazarotene is a retinoid product related to Vitamin A. It is thought to work by affecting skin cell growth. For the best effect, this medication should be used with a total skin care program.

HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using tazarotene and each time you get a refill. If you have any questions, ask your doctor or pharmacist.This medication is for use on the skin only. Wash and dry your hands before applying the medication. Apply this medication to the skin as directed by your doctor, usually once daily at bedtime. Wash your hands after applying, unless you are treating your hands for psoriasis. If this medication accidentally gets on areas you do not need to treat, wash it off to help prevent skin irritation. Do not apply this medication to skin that is cut, scraped, sunburned, or affected by certain other skin conditions (eczema, seborrheic dermatitis). Avoid getting this medication in your eyes, mouth, or on your eyelids or lips. If this happens, rinse right away with plenty of cool water.If you are using a product that is for treating psoriasis, apply a thin film to cover only the psoriatic plaques. If a bath or shower is taken before application, make sure skin is dry before applying. If a moisturizer is used, apply it at least an hour before applying this medication.If you are using a product that is for treating acne, wash and dry the affected area(s). After skin is dry, apply a thin film to acne. If you are using the lotion to treat acne on the face, dot onto the chin, cheeks, nose, and forehead, then gently rub over the entire face. Use enough to cover all of the affected area(s). If you are also using other acne medication (such as benzoyl peroxide) on your skin, apply one product in the morning and one product in the evening to separate the application times. If a moisturizer is used, make sure to allow skin to dry before applying either the moisturizer or tazarotene.If you are using the foam, shake the can before each use. The foam is flammable. Avoid smoking or going near an open flame while applying the medication.Do not cover, bandage, or wrap the affected area(s). Do not apply this medication to normal, healthy skin.Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day.Do not use large amounts or apply this medication more often than directed, or use it for longer than prescribed. Your condition will not improve faster, and your risk of side effects will increase.Since this drug is absorbed through the skin and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication.Tell your doctor if your condition does not get better or if it gets worse.

SIDE EFFECTS: Itching, redness, irritation, burning/stinging, scaling, dry skin, or pain at the application site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: severe redness/irritation/peeling.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using tazarotene, tell your doctor or pharmacist if you are allergic to it; or to vitamin A-related drugs (other retinoids such as isotretinoin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: other skin conditions (such as eczema, seborrheic dermatitis, sunburn, sun sensitivity).This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen daily and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness. Wait until your skin has completely recovered from a sunburn before using this medication. Wind or cold weather may also be irritating to the skin while using this medication.Avoid electrolysis, waxing, and chemical depilatories for hair removal on the treated areas while using this product.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).This medication must not be used during pregnancy. It may harm an unborn baby. Your doctor may order a pregnancy test within 2 weeks before starting this medication. This medication should be started during a normal menstrual period. Discuss the use of reliable forms of birth control (such as condoms, birth control pills) with your doctor. If you become pregnant or think you may be pregnant, tell your doctor right away.Since this drug is absorbed through the skin and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication.It is unknown if this drug passes into breast milk. To avoid direct contact, breast-feeding women should not apply this medication to the nipple and areola. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug are: vitamin A products, hair perming solutions, other skin products with strong drying effects, skin products containing alcohol/lime/spice (such as shaving lotions, astringents such as calamine lotion, perfume), soaps/shampoos/cleansers that are medicated/abrasive.

OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe redness/irritation/peeling.

NOTES: Do not share this medication with others.

MISSED DOSE: If you miss a dose, apply it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Apply your next dose at the regular time. Do not apply extra medicine to make up for the missed dose.

STORAGE: Different brands of this medication have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised November 2021. Copyright(c) 2022 First Databank, Inc.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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Formulary

FormularyPatient Discounts

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Adding plans allows you to:

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.