Tazarotene

Tazarotene
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Vignesh Ponnusamy, M.B.B.S. [2]

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Overview

Tazarotene is a retinoid that is FDA approved for the {{{indicationType}}} of plaque psoriasis and acne vulgaris. Common adverse reactions include pruritus, erythema, desquamation, dry skin, and burning sensation.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Psoriasis

• It is recommended that treatment starts with TAZORAC® Cream, 0.05%, with strength increased to 0.1% if tolerated and medically indicated. Apply a thin film (2 mg/cm2) of TAZORAC® Cream once per day, in the evening, to cover only the psoriatic lesions. If a bath or shower is taken prior to application, the skin should be dry before applying the cream. If emollients are used, they should be applied at least an hour before application of TAZORAC® Cream. Because unaffected skin may be more susceptible to irritation, application of TAZORAC® Cream to these areas should be carefully avoided.

Acne Vulgaris

• Cleanse the face gently. After the skin is dry, apply a thin layer (2 mg/cm2) of TAZORAC® Cream 0.1% once per day, in the evening, to the skin areas where acne lesions appear. Use enough to cover the entire affected area.

• TAZORAC® Cream is for topical use only. TAZORAC® Cream is not for ophthalmic, oral, or intravaginal use. If contact with eyes occurs, rinse thoroughly with water.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Tazarotene in adult patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Tazarotene in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Tazarotene in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Tazarotene in pediatric patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Tazarotene in pediatric patients.

Contraindications

• Pregnancy

• TAZORAC® Cream may cause fetal harm when administered to a pregnant woman. Tazarotene elicits teratogenic and developmental effects associated with retinoids after topical or systemic administration in rats and rabbits. TAZORAC® Cream is contraindicated in women who are pregnant or may become pregnant.
• If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, treatment should be discontinued and the patient should be apprised of the potential hazard to the fetus.

• Hypersensitivity

• TAZORAC® Cream is contraindicated in individuals who have shown hypersensitivity to any of its components.

Warnings

Precautions

• Embryofetal Toxicity

• Systemic exposure to tazarotenic acid is dependent upon the extent of the body surface area treated. In patients treated topically over sufficient body surface area, exposure could be in the same order of magnitude as in orally treated animals. Although there may be less systemic exposure in the treatment of acne of the face alone due to less surface area for application, tazarotene is a teratogenic substance, and it is not known what level of exposure is required for teratogenicity in humans.
• There were thirteen reported pregnancies in subjects who participated in the clinical trials for topical tazarotene. Nine of the subjects were found to have been treated with topical tazarotene, and the other four had been treated with vehicle. One of the subjects who was treated with tazarotene cream elected to terminate the pregnancy for non-medical reasons unrelated to treatment. The other eight pregnant women who were inadvertently exposed to topical tazarotene during clinical trials subsequently delivered apparently healthy babies. As the exact timing and extent of exposure in relation to the gestation times are not certain, the significance of these findings is unknown.

• Females of Child-bearing Potential

• Females of child-bearing potential should be warned of the potential risk and use adequate birth-control measures when TAZORAC® Cream is used. The possibility that a female of child-bearing potential is pregnant at the time of institution of therapy should be considered.
• A negative result for pregnancy test should be obtained within 2 weeks prior to TAZORAC® Cream therapy. TAZORAC® Cream therapy should begin during a menstrual period.

• Local Irritation

• Application of TAZORAC® Cream may cause excessive irritation in the skin of certain sensitive individuals. Some individuals may experience excessive pruritus, burning, skin redness or peeling. If these effects occur, the medication should either be discontinued until the integrity of the skin is restored, or the dosing should be reduced to an interval the patient can tolerate. However, efficacy at reduced frequency of application has not been established. Alternatively, patients with psoriasis who are being treated with the 0.1% concentration can be switched to the lower concentration. Frequency of application should be closely monitored by careful observation of the clinical therapeutic response and skin tolerance. Therapy can be resumed, or the drug concentration or frequency of application can be increased as the patient becomes able to tolerate treatment.
• Concomitant topical medications and cosmetics that have a strong drying effect should be avoided. It is also advisable to "rest" a patient's skin until the effects of such preparations subside before use of TAZORAC® Cream is begun.
• TAZORAC® Cream, 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 TAZORAC® Cream.

• Photosensitivity and Risk for 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 the use of TAZORAC® Cream. Patients must be warned to use sunscreens (minimum SPF of 15) and protective clothing when using TAZORAC® Cream. Patients with sunburn should be advised not to use TAZORAC® Cream 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 TAZORAC® Cream.
• TAZORAC® Cream should be administered with caution if the patient is also taking drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the increased possibility of augmented photosensitivity.

Adverse Reactions

Clinical 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.

• In human dermal safety trials, TAZORAC® Cream, 0.05% and 0.1% did not induce allergic contact sensitization, phototoxicity, or photoallergy.

• Psoriasis

• The most frequent adverse reactions reported with TAZORAC® Cream, 0.05% and 0.1% occurring in 10 to 23% of subjects, in descending order, included pruritus, erythema, and burning. Reactions occurring in greater than 1 to less than 10% of subjects, in descending order, included irritation, desquamation, stinging, contact dermatitis, dermatitis, eczema, worsening of psoriasis, skin pain, rash, hypertriglyceridemia, dry skin, skin inflammation, and peripheral edema.
• TAZORAC® Cream, 0.1% was associated with a greater degree of local irritation than the 0.05% cream. The rates of irritation adverse reactions reported during psoriasis trials with TAZORAC® Cream, 0.1% were 0.1-0.4% higher than those reported for TAZORAC® Cream, 0.05%.

• Acne

• The most frequent adverse reactions reported during clinical trials with TAZORAC® Cream 0.1% in the treatment of acne, occurring in 10-30% of subjects, in descending order included desquamation, dry skin, erythema, and burning sensation. Reactions occurring in 1 to 5% of subjects included pruritus, irritation, face pain, and stinging.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Tazarotene in the drug label.

Drug Interactions

• No formal drug-drug interaction studies were conducted with TAZORAC® Cream.

• In a trial of 27 healthy female subjects between the ages of 20–55 years receiving a combination oral contraceptive tablet containing 1 mg norethindrone and 35 mcg ethinyl estradiol, concomitant use of tazarotene administered as 1.1 mg orally (mean ± SD Cmax and AUC0-24 of tazarotenic acid were 28.9 ± 9.4 ng/mL and 120.6 ± 28.5 ng∙hr/mL) did not affect the pharmacokinetics of norethindrone and ethinyl estradiol over a complete cycle.

• The impact of tazarotene on the pharmacokinetics of progestin only oral contraceptives (i.e., minipills) has not been evaluated.

Close

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category X

• There are no adequate and well-controlled studies with TAZORAC® Cream in pregnant women. TAZORAC® Cream is contraindicated in women who are or may become pregnant. Females of child-bearing potential should be warned of the potential risk and use adequate birth-control measures when TAZORAC® Cream is used. The possibility that a female of child-bearing potential is pregnant at the time of institution of therapy should be considered. A negative result for pregnancy test should be obtained within 2 weeks prior to TAZORAC® Cream therapy, which should begin during a menstrual period. Systemic exposure to tazarotenic acid is dependent upon the extent of the body surface area treated. In subjects treated topically over sufficient body surface area, exposure could be in the same order of magnitude as in orally treated animals. Although there may be less systemic exposure in the treatment of acne of the face alone due to less surface area for application, tazarotene is a teratogenic substance, and it is not known what level of exposure is required for teratogenicity in humans.

• In rats, a tazarotene gel, 0.05% formulation, administered topically during gestation days 6 through 17 at 0.25 mg/kg/day resulted in reduced fetal body weights and reduced skeletal ossification. Rabbits dosed topically with 0.25 mg/kg/day tazarotene gel during gestation days 6 through 18 were noted with single incidences of known retinoid malformations, including spina bifida, hydrocephaly, and heart anomalies.

• Systemic exposure to tazarotenic acid at topical doses of 0.25 mg/kg/day tazarotene in a gel formulation in rats and rabbits represented 1.2 and 13 times, respectively, that in a psoriatic patient treated with 0.1% tazarotene cream at 2 mg/cm2 over a 35% body surface area in a controlled pharmacokinetic study, and 4 and 44 times the maximum systemic exposure in acne patients treated with tazarotene cream, 0.1% at 2 mg/cm2 over a 15% body surface area.

• When tazarotene was given orally to experimental animals, developmental delays were seen in rats; and teratogenic effects and post-implantation loss were observed in rats and rabbits at doses producing 1.1 and 26 times, respectively, the systemic exposure seen in a psoriatic patient treated topically with tazarotene cream, 0.1% at 2 mg/cm2 over a 35% body surface area in a controlled pharmacokinetic study and 3.5 and 85 times the maximum systemic exposure in acne patients treated with tazarotene cream, 0.1% at 2 mg/cm2 over a 15% body surface area.

• In female rats orally administered 2 mg/kg/day of tazarotene from 15 days before mating through gestation day 7, a number of classic developmental effects of retinoids were observed including decreased number of implantation sites, decreased litter size, decreased numbers of live fetuses, and decreased fetal body weights. A low incidence of retinoid-related malformations at that dose was observed. The dose produced a systemic exposure 3.4 times that observed in a psoriatic patient treated with tazarotene cream, 0.1% at 2 mg/cm2 over a 35% body surface area and 11 times the maximum systemic exposure in acne patients treated with tazarotene cream, 0.1% at 2 mg/cm2 over a 15% body surface area.

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Tazarotene in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Tazarotene during labor and delivery.

Nursing Mothers

• After single topical doses of 14C-tazarotene gel to the skin of lactating rats, radioactivity was detected in milk, suggesting that there would be transfer of drug-related material to the offspring via milk. It is not known whether this drug is excreted in human milk. The safe use of TAZORAC® Cream during lactation has not been established. A decision should be made whether to discontinue breast-feeding or to discontinue TAZORAC® Cream therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Pediatric Use

• The safety and efficacy of tazarotene have not been established in patients with psoriasis under the age of 18 years, or in patients with acne under the age of 12 years.

Geriatic Use

• TAZORAC® Cream for the treatment of acne has not been clinically tested in persons 65 years of age or older.

• Of the total number of subjects in clinical trials of TAZORAC® Cream for plaque psoriasis, 120 were over the age of 65. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Currently there is no other clinical experience on the differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Gender

There is no FDA guidance on the use of Tazarotene with respect to specific gender populations.

Race

There is no FDA guidance on the use of Tazarotene with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Tazarotene in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Tazarotene in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Tazarotene in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Tazarotene in patients who are immunocompromised.

Administration and Monitoring

Administration

• Topical

Monitoring

There is limited information regarding Monitoring of Tazarotene in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Tazarotene in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Excessive topical use of TAZORAC® Cream, 0.05% and 0.1% may lead to marked redness, peeling, or discomfort.

• TAZORAC® Cream, 0.05% and 0.1% are not for oral use. Oral ingestion of the drug may lead to the same adverse effects as those associated with excessive oral intake of Vitamin A (hypervitaminosis A) or other retinoids.

Management

• If oral ingestion occurs, the patient should be monitored, and appropriate supportive measures should be administered as necessary.

Chronic Overdose

There is limited information regarding Chronic Overdose of Tazarotene in the drug label.

Pharmacology

Mechanism of Action

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Tazarotene in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Tazarotene in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Tazarotene in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Tazarotene in the drug label.

How Supplied

Storage

There is limited information regarding Tazarotene Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Tazarotene in the drug label.

Precautions with Alcohol

• Alcohol-Tazarotene interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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