tazarotene (Avage, Tazorac, Fabior)

Dosing and uses of Avage, Tazorac (tazarotene topical)

• Adult
• Pediatric

 

Adult dosage forms and strengths

cream, topical (Avage)

• 0.1%

cream/gel, topical (Tazorac)

• 0.05%
• 0.1%

foam, topical (Fabior)

• 0.1%

 

Acne Vulgaris (Tazorac, Fabior)

Tazorac, 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
• Cream/gel/foam 0.1%: Apply to affected area qDay

 

Psoriasis (Tazorac)

Tazorac

• Indicated for topical treatment of stable plaque psoriasis; gel indicated for up to 20% 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, or dermal elastosis)

Not indicated for prevention of actinic keratoses, skin neoplasms, or lentigo maligna

Cream 0.1%: Apply to affected areas qHs

 

Limitations Of Use

Does not eliminate or prevent wrinkles or restore more youthful skin

Does not repair sun damaged skin or reverse photoaging

 

Pediatric dosage forms and strengths

cream/gel, topical (Tazorac)

• 0.05%
• 0.1%

foam, topical (Fabior)

• 0.1%

 

Acne Vulgaris

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

 

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

 

Avage, Tazorac (tazarotene topical) adverse (side) effects

>10%

Desquamation

Erythema

Burning/stinging

Dry skin

 

1-10%

Skin irritation (1% -22%)

Skin pain

Pruritis

Irritant or contact dermatitis

Stinging

Acne

Photosensitivity

Rash

Cheilitis

 

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

 

Warnings

Contraindications

Pregnancy (teratogenic); hypersensitivity, eczema

 

Cautions

Re-evaluate if not healed in 10 days

May cause fetal harm when administered to a pregnant woman; obtain a pregnancy test in females of reproductive potential within 2 weeks prior to initiating treatment; advise females of reproductive potential to use effective contraception

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

Use of sunscreens (minimum strength of SPF 15) & protective clothing recommended during use

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

Ask patients if they are using other drugs that could potentially increase sunlight sensitivity (eg, fluoroquinolone or tetracycline anti-infectives, thiazide diuretics, sulfonamides, phenothiazines)

Nof for use in lentigo maligna; carefully assess facial pigmented lesions of concern before application of cream

 

Pregnancy and lactation

Pregnancy category: X

Lactation: not known if distributed into breast milk

 

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.

 

Pharmacology of Avage, Tazorac (tazarotene topical)

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

 

Metabolism

Hydrolyzed to its active metabolite, tazarotenic acid

 

Elimination

Half-Life: 18 hr