Retinoid

Tazarotene

Approved 13 Sept 2022TopicalGel

The FDA lists this product in 13 strengths and forms.

Indications

Tazarotene gel, 0.1% is a retinoid indicated for the topical treatment of plaque psoriasis of up to 20% body surface area involvement. ( 1.1 ) Tazarotene gel, 0.1% is indicated for the topical treatment of mild to moderate facial acne vulgaris. ( 1.2 ) Limitations of Use The safety of tazarotene gel use on more than 20% body surface area has not been established. ( 1.3 )

1.1Plaque Psoriasis

Tazarotene gel, 0.1% is indicated for the topical treatment of patients with plaque psoriasis of up to 20% body surface area involvement.

1.2Acne Vulgaris

Tazarotene gel, 0.1% is also indicated for the topical treatment of patients with facial acne vulgaris of mild to moderate severity. The efficacy of tazarotene gel in the treatment of acne previously treated with other retinoids or resistant to oral antibiotics has not been established.

1.3Limitations of Use

The safety of tazarotene gel use on more than 20% body surface area has not been established in psoriasis or acne [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 )].

Contraindications

Tazarotene gel is contraindicated in: Pregnancy. Retinoids may cause fetal harm when administered to a pregnant female [see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.1 , 8.3 )]. Individuals who have known hypersensitivity to any of its components [see Warnings and Precautions ( 5.2 )]. Pregnancy ( 4 , 8.1 ) Hypersensitivity ( 4 )

Warnings and precautions

Embryofetal Toxicity: Tazarotene gel contains tazarotene, which is a teratogen. Tazarotene gel is contraindicated in pregnancy. Females of child-bearing potential should have a negative pregnancy test within 2 weeks prior to initiating treatment and use an effective method of contraception during treatment. ( 5.1 ) Local Irritation: Excessive pruritus, burning, skin redness or peeling can occur. If these reactions occur, discontinue until the integrity of the skin has been restored, or consider reducing dosing frequency or in the case of psoriasis, consider switching to the lower concentration.

At a glance

Brand name: Tazarotene
Pharmacologic class: Retinoid
Route: Topical
Dosage form: Gel
Applicant: Cosette
Status: Prescription
FDA approval: 13 Sept 2022
Application: ANDA214136-001

Indications

1.1Plaque Psoriasis

Tazarotene gel, 0.1% is indicated for the topical treatment of patients with plaque psoriasis of up to 20% body surface area involvement.

1.2Acne Vulgaris

1.3Limitations of Use

The safety of tazarotene gel use on more than 20% body surface area has not been established in psoriasis or acne [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 )].

Contraindications

Warnings and precautions

Adverse reactions

The following serious adverse reactions are discussed in more detail in other sections of the labeling: Embryofetal toxicity [see Warnings and Precautions ( 5.1 )] Photosensitivity and Risk of Sunburn [see Warnings and Precautions ( 5.3 )] Plaque Psoriasis: Most common adverse reactions occurring in 10 to 30% of patients are pruritus, burning/stinging, erythema, worsening of psoriasis, irritation, and skin pain. ( 6.1 ) Acne Vulgaris: Most common adverse reactions occurring in 10 to 30% of patients are desquamation, burning/stinging, dry skin, erythema and pruritus.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Psoriasis A total of 439 subjects 14 to 87 years of age were treated with tazarotene gel, 0.05% and 0.1% in two controlled clinical trials. The most frequent adverse events reported with tazarotene gel, 0.05% and 0.1% occurring in 10 to 30% of subjects, in descending order, included pruritus, burning/stinging, erythema, worsening of psoriasis, irritation, and skin pain.

Reactions occurring in 1 to 10% of subjects included rash, desquamation, irritant contact dermatitis, skin inflammation, fissuring, bleeding, and dry skin. Increases in “psoriasis worsening” and “sun-induced erythema” were noted in some subjects over the 4th to 12th months of treatment as compared to the first three months of a 1 year study. In general, the incidence of adverse events with tazarotene gel 0.05% was 2 to 5% lower than that seen with tazarotene gel 0.1%.

Acne A total of 596 subjects 12 to 44 years of age were treated with tazarotene gel, 0.05% and 0.1% in two controlled clinical trials. The most frequent adverse events reported during clinical trials with tazarotene gel, 0.1% in the treatment of acne occurring in 10 to 30% of subjects, in descending order, included desquamation, burning/stinging, dry skin, erythema and pruritus. Reactions occurring in 1 to 10% of subjects included irritation, skin pain, fissuring, localized edema and skin discoloration.

6.2Postmarketing Experience

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions have been identified during postapproval use of tazarotene. Skin and subcutaneous tissue disorders: blister, dermatitis, urticaria, skin exfoliation, skin discoloration (including skin hyperpigmentation or skin hypopigmentation), swelling at or near application sites, and pain.

Tazarotene

Indications

1.1Plaque Psoriasis

1.2Acne Vulgaris

1.3Limitations of Use

Contraindications

Warnings and precautions

At a glance

Two medicines in one question?

Tazarotene

Indications

1.1Plaque Psoriasis

1.2Acne Vulgaris

1.3Limitations of Use

Contraindications

Warnings and precautions

At a glance

Two medicines in one question?

5.1Embryofetal Toxicity Based

5.2Local Irritation and Hypersensitivity Reactions Application

5.3Photosensitivity and Risk for Sunburn Because

Interactions

Adverse reactions

6.1Clinical Trials Experience

6.2Postmarketing Experience

Composition

Strengths and forms

Official product information