tazarotene (Rx)

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

AdultPediatric

Dosage Forms & Strengths

cream, topical (Avage)

  • 0.1%

cream/gel, topical (Tazorac)

  • 0.05%
  • 0.1%

foam, topical (Fabior)

  • 0.1%

lotion, topical (Arazlo)

  • 0.045%

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/gel, topical (Tazorac)

  • 0.05%
  • 0.1%

foam, topical (Fabior)

  • 0.1%

lotion, topical (Arazlo)

  • 0.045%

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

May cause fetal harm when administered to a pregnant woman

Some individuals may experience excessive pruritus, burning, skin redness, or peeling; if these reactions occur, discontinue therapy until integrity of skin has been restored or reduce dosing interval; avoid use on eczematous skin, as such use may cause severe irritation

Local tolerability reactions and hypersensitivity adverse reactions have been observed with topical tazarotene, including blistering, skin desquamation, and urticaria; if adverse reactions occur, discontinue medication until integrity of skin is restored, or reduce dosing to an interval the patient can tolerate

Closely monitor frequency of application by carefully observing therapeutic response and skin tolerance

Avoid using cream if patient is also 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

Avoid exposure to sunlight, sunlamps, and weather extremes; in sunburn, do not use tazarotene until full recovery

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

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

  • 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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Formulary

FormularyPatient Discounts

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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.