These Highlights Do Not Include All The Information Needed To Use Tazarotene Cream Safely And Effectively. See Full Prescribing Information For Tazarotene Cream.

Females of Child-bearing Potential

Females of child-bearing potential should be warned of the potential risk and use adequate birth-control measures when tazarotene 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 tazarotene cream therapy. Tazarotene cream therapy should begin during a menstrual period [see Use in Specific Populations (8.1)] .

Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature].

Cleanse the face gently. After the skin is dry, apply a thin layer (2 mg/cm ²) of tazarotene 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.

Use effective sunscreens and wear protective clothing while using tazarotene cream [see Warnings and Precautions (5.3)].

Excessive topical use of tazarotene cream, 0.1% may lead to marked redness, peeling, or discomfort [see Warnings and Precautions (5.2)] .

Tazarotene cream, 0.1% is 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. If oral ingestion occurs, the patient should be monitored, and appropriate supportive measures should be administered as necessary.

It is recommended that treatment starts with tazarotene cream, 0.05%, with strength increased to 0.1% if tolerated and medically indicated. Apply a thin film (2 mg/cm ²) of tazarotene 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 tazarotene cream. Because unaffected skin may be more susceptible to irritation, application of tazarotene cream to these areas should be carefully avoided.

Tazarotene cream, 0.1% is for topical use and contains the active ingredient, tazarotene. Each gram of tazarotene cream, 0.1% contains 1 mg of tazarotene in a white cream base.

Tazarotene is a member of the acetylenic class of retinoids. Chemically, tazarotene is ethyl 6-[(4,4-dimethylthiochroman-6-yl)ethynyl]nicotinate. The compound has an empirical formula of C ₂₁H ₂₁NO ₂S and molecular weight of 351.46. The structural formula is shown below:

Tazarotene cream contains the following inactive ingredients: benzyl alcohol 1%, carbomer copolymer type B, carbomer homopolymer type B, edetate disodium, medium-chain triglycerides, mineral oil, purified water, sodium hydroxide (to adjust pH), sodium thiosulfate, and sorbitan monooleate.

Tazarotene cream, 0.1% is also indicated for the topical treatment of patients with acne vulgaris.

The safety and efficacy of tazarotene cream 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.

Tazarotene 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 tazarotene 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 subjects, but greater sensitivity of some older individuals cannot be ruled out.

In two 12-week vehicle-controlled clinical trials, tazarotene cream, 0.05% and 0.1% was significantly more effective than vehicle in reducing the severity of stable plaque psoriasis. Tazarotene cream, 0.1% and 0.05% demonstrated superiority over vehicle cream as early as 1 week and 2 weeks, respectively, after starting treatment.

In these trials, the primary efficacy endpoint was "clinical success," defined as the proportion of subjects with none, minimal, or mild overall lesional assessment at Week 12, and shown in Table 1. "Clinical success" was also significantly greater with tazarotene cream, 0.05% and 0.1% versus vehicle at most follow-up visits.

At the end of 12 weeks of treatment, tazarotene cream, 0.05% and 0.1% was consistently superior to vehicle in reducing the plaque thickness of psoriasis. Improvements in erythema and scaling were generally significantly greater with tazarotene cream, 0.05% and 0.1% than with vehicle. Tazarotene Cream, 0.1% was also generally more effective than tazarotene cream, 0.05% in reducing the severity of the individual signs of disease. However, tazarotene cream, 0.1% was associated with a greater degree of local irritation than tazarotene cream, 0.05%.

Tazarotene cream 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)].

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)]

No formal drug-drug interaction studies were conducted with tazarotene cream.

In a trial of 27 healthy female subjects between the ages of 20 to 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 C _maxand AUC _0-24of 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.

Tazarotene cream, 0.1% is indicated for the topical treatment of patients with plaque psoriasis.

Following topical application, tazarotene undergoes esterase hydrolysis to form its active metabolite, tazarotenic acid. Little parent compound could be detected in the plasma. Tazarotenic acid was highly bound to plasma proteins (greater than 99%). Tazarotene and tazarotenic acid were metabolized to sulfoxides, sulfones and other polar metabolites which were eliminated through urinary and fecal pathways. The half-life of tazarotenic acid was approximately 18 hours, following topical application of tazarotene to normal, acne or psoriatic skin.

In a multiple dose trial with a once daily dose for 14 consecutive days in 9 psoriatic subjects (male=5; female=4), measured doses of tazarotene cream, 0.1% were applied by medical staff to involved skin without occlusion (5 to 35% of total body surface area: mean ± SD: 14 ± 11%). The C _maxof tazarotenic acid was 2.31 ± 2.78 ng/mL occurring 8 hours after the final dose, and the AUC _0-24hwas 31.2 ± 35.2 ng∙hr/mL on day 15 in the five subjects who were administered clinical doses of 2 mg cream/cm ².

During clinical trials with tazarotene cream, 0.05% or 0.1% treatment for plaque psoriasis, three out of 139 subjects with their systemic exposure monitored had detectable plasma tazarotene concentrations, with the highest value at 0.09 ng/mL. Tazarotenic acid was detected in 78 out of 139 subjects (LLOQ = 0.05 ng/mL). Three subjects using tazarotene cream 0.1% had plasma tazarotenic acid concentrations greater than 1 ng/mL. The highest value was 2.4 ng/mL. However, because of the variations in the time of blood sampling, the area of psoriasis involvement, and the dose of tazarotene applied, actual maximal plasma levels are unknown.

Tazarotene cream 0.1% was applied once daily to either the face (N=8) or to 15% of body surface area (N=10) of female subjects with moderate to severe acne vulgaris. The mean C _maxand AUC values of tazarotenic acid peaked at day 15 for both dosing groups during a 29 day treatment period. Mean C _maxand AUC _0-24hvalues of tazarotenic acid from subjects in the 15% body surface area dosing group were more than 10 times higher than those from subjects in the face-only dosing group. The single highest C _maxthroughout the trial period was 1.91 ng/mL on day 15 in the exaggerated dosing group. In the face-only group, the mean ± SD values of C _maxand AUC _0-24hof tazarotenic acid on day 15 were 0.10 ± 0.06 ng/mL and 1.54 ± 1.01 ng∙hr/mL, respectively, whereas in the 15% body surface area dosing group, the mean ± SD values of C _maxand AUC _0-24hof tazarotenic acid on day 15 were 1.20 ± 0.41 ng/mL and 17.01 ± 6.15 ng∙hr/mL, respectively. The steady state pharmacokinetics of tazarotenic acid had been reached by day 8 in the face-only and by day 15 in the 15% body surface area dosing groups.

In a Phase 3 clinical trial, tazarotene cream, 0.1% was applied once daily for 12 weeks to each of 48 subjects (22 females and 26 males) with facial acne vulgaris. The mean ± SD values of plasma tazarotenic acid at weeks 4 and 8 were 0.078 ± 0.073 ng/mL (N=47) and 0.052 ± 0.037 ng/mL (N=42), respectively. The highest observed individual plasma tazarotenic acid concentration was 0.41 ng/mL at week 4 from a female subject. The magnitude of plasma tazarotenic acid concentrations appears to be independent of gender, age, and body weight.

• Tazarotene cream 0.1% is a retinoid indicated for the topical treatment of plaque psoriasis. ( 1.1)
• Tazarotene cream 0.1% is indicated for the topical treatment of acne vulgaris. ( 1.2)

Tazarotene is a retinoid prodrug which is converted to its active form, the carboxylic acid of tazarotene, by deesterification. Tazarotenic acid binds to all three members of the retinoic acid receptor (RAR) family: RARα, RARβ, and RARγ, but shows relative selectivity for RARβ, and RARγ and may modify gene expression. The clinical significance of these findings is unknown.

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 [see Clinical Pharmacology (12.3)] .

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.

• Embryofetal Toxicity: Tazarotene cream contains tazarotene, which is a teratogenic substance. Tazarotene cream 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: Some individuals may experience excessive pruritus, burning, skin redness or peeling. If these effects occur, discontinue until the integrity of the skin has been restored, or reduce dosing interval, or in the case of psoriasis, may switch to the lower concentration. Tazarotene cream should not be used on eczematous skin, as it may cause severe irritation. ( 5.2)
• Photosensitivity and Risk for Sunburn: Avoid exposure to sunlight, sunlamps, and weather extremes. Wear sunscreen daily. Tazarotene cream should be administered with caution if the patient is also taking drugs known to be photosensitizers. ( 5.3)

• Apply a thin layer of tazarotene cream only to the affected area once daily in the evening. ( 2.1, 2.2)
• Not for ophthalmic, oral, or intravaginal use. ( 2.2)
• If contact with eyes occurs, rinse thoroughly with water. ( 2.2)

Cream, 0.1%. Each gram of tazarotene cream, 0.1% contains 1 mg of tazarotene in a white cream base.

The following adverse reactions have been identified during postapproval use of tazarotene. 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.

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.

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, tazarotene cream, 0.05% and 0.1% did not induce allergic contact sensitization, phototoxicity, or photoallergy.

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Tazarotene cream is a white cream available in a concentration of 0.1%. It is supplied in a collapsible aluminum tube with a tamper-evident aluminum membrane over the opening and a white polypropylene screw cap, in 30 g and 60 g sizes.

Tazarotene Cream, 0.1%

30 gram NDC 51672-1373-2

60 gram NDC 51672-1373-3

Tazarotene cream is for topical use only. Tazarotene cream is not for ophthalmic, oral, or intravaginal use. If contact with mucous membranes occurs, rinse thoroughly with water [see Warnings and Precautions (5.2)] . Wash hands thoroughly after application.

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 tazarotene cream. Patients must be warned to use sunscreens and protective clothing when using tazarotene cream. Patients with sunburn should be advised not to use tazarotene 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 tazarotene cream.

Tazarotene 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.

NDC 51672-1373-2

Tazarotene

Cream 0.1%

FOR DERMATOLOGICAL USE ONLY.

NOT FOR OPHTHALMIC USE.

Keep this and all medications out of the reach of children.

30 g

Rx only

Local tolerability reactions (including blistering and skin desquamation) and hypersensitivity adverse reactions (including urticaria) have been observed with topical tazarotene. Application of tazarotene 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 tazarotene cream is begun.

Tazarotene 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 tazarotene cream.

Females of Child-bearing Potential

Females of child-bearing potential should be warned of the potential risk and use adequate birth-control measures when tazarotene 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 tazarotene cream therapy. Tazarotene cream therapy should begin during a menstrual period [see Use in Specific Populations (8.1)] .

Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature].

Cleanse the face gently. After the skin is dry, apply a thin layer (2 mg/cm ²) of tazarotene 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.

Use effective sunscreens and wear protective clothing while using tazarotene cream [see Warnings and Precautions (5.3)].

Excessive topical use of tazarotene cream, 0.1% may lead to marked redness, peeling, or discomfort [see Warnings and Precautions (5.2)] .

Tazarotene cream, 0.1% is 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. If oral ingestion occurs, the patient should be monitored, and appropriate supportive measures should be administered as necessary.

It is recommended that treatment starts with tazarotene cream, 0.05%, with strength increased to 0.1% if tolerated and medically indicated. Apply a thin film (2 mg/cm ²) of tazarotene 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 tazarotene cream. Because unaffected skin may be more susceptible to irritation, application of tazarotene cream to these areas should be carefully avoided.

Tazarotene cream, 0.1% is for topical use and contains the active ingredient, tazarotene. Each gram of tazarotene cream, 0.1% contains 1 mg of tazarotene in a white cream base.

Tazarotene is a member of the acetylenic class of retinoids. Chemically, tazarotene is ethyl 6-[(4,4-dimethylthiochroman-6-yl)ethynyl]nicotinate. The compound has an empirical formula of C ₂₁H ₂₁NO ₂S and molecular weight of 351.46. The structural formula is shown below:

Tazarotene cream contains the following inactive ingredients: benzyl alcohol 1%, carbomer copolymer type B, carbomer homopolymer type B, edetate disodium, medium-chain triglycerides, mineral oil, purified water, sodium hydroxide (to adjust pH), sodium thiosulfate, and sorbitan monooleate.

Tazarotene cream, 0.1% is also indicated for the topical treatment of patients with acne vulgaris.

The safety and efficacy of tazarotene cream 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.

Tazarotene 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 tazarotene 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 subjects, but greater sensitivity of some older individuals cannot be ruled out.

In two 12-week vehicle-controlled clinical trials, tazarotene cream, 0.05% and 0.1% was significantly more effective than vehicle in reducing the severity of stable plaque psoriasis. Tazarotene cream, 0.1% and 0.05% demonstrated superiority over vehicle cream as early as 1 week and 2 weeks, respectively, after starting treatment.

In these trials, the primary efficacy endpoint was "clinical success," defined as the proportion of subjects with none, minimal, or mild overall lesional assessment at Week 12, and shown in Table 1. "Clinical success" was also significantly greater with tazarotene cream, 0.05% and 0.1% versus vehicle at most follow-up visits.

At the end of 12 weeks of treatment, tazarotene cream, 0.05% and 0.1% was consistently superior to vehicle in reducing the plaque thickness of psoriasis. Improvements in erythema and scaling were generally significantly greater with tazarotene cream, 0.05% and 0.1% than with vehicle. Tazarotene Cream, 0.1% was also generally more effective than tazarotene cream, 0.05% in reducing the severity of the individual signs of disease. However, tazarotene cream, 0.1% was associated with a greater degree of local irritation than tazarotene cream, 0.05%.

Tazarotene cream 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)].

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)]

No formal drug-drug interaction studies were conducted with tazarotene cream.

In a trial of 27 healthy female subjects between the ages of 20 to 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 C _maxand AUC _0-24of 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.

Tazarotene cream, 0.1% is indicated for the topical treatment of patients with plaque psoriasis.

Following topical application, tazarotene undergoes esterase hydrolysis to form its active metabolite, tazarotenic acid. Little parent compound could be detected in the plasma. Tazarotenic acid was highly bound to plasma proteins (greater than 99%). Tazarotene and tazarotenic acid were metabolized to sulfoxides, sulfones and other polar metabolites which were eliminated through urinary and fecal pathways. The half-life of tazarotenic acid was approximately 18 hours, following topical application of tazarotene to normal, acne or psoriatic skin.

In a multiple dose trial with a once daily dose for 14 consecutive days in 9 psoriatic subjects (male=5; female=4), measured doses of tazarotene cream, 0.1% were applied by medical staff to involved skin without occlusion (5 to 35% of total body surface area: mean ± SD: 14 ± 11%). The C _maxof tazarotenic acid was 2.31 ± 2.78 ng/mL occurring 8 hours after the final dose, and the AUC _0-24hwas 31.2 ± 35.2 ng∙hr/mL on day 15 in the five subjects who were administered clinical doses of 2 mg cream/cm ².

During clinical trials with tazarotene cream, 0.05% or 0.1% treatment for plaque psoriasis, three out of 139 subjects with their systemic exposure monitored had detectable plasma tazarotene concentrations, with the highest value at 0.09 ng/mL. Tazarotenic acid was detected in 78 out of 139 subjects (LLOQ = 0.05 ng/mL). Three subjects using tazarotene cream 0.1% had plasma tazarotenic acid concentrations greater than 1 ng/mL. The highest value was 2.4 ng/mL. However, because of the variations in the time of blood sampling, the area of psoriasis involvement, and the dose of tazarotene applied, actual maximal plasma levels are unknown.

Tazarotene cream 0.1% was applied once daily to either the face (N=8) or to 15% of body surface area (N=10) of female subjects with moderate to severe acne vulgaris. The mean C _maxand AUC values of tazarotenic acid peaked at day 15 for both dosing groups during a 29 day treatment period. Mean C _maxand AUC _0-24hvalues of tazarotenic acid from subjects in the 15% body surface area dosing group were more than 10 times higher than those from subjects in the face-only dosing group. The single highest C _maxthroughout the trial period was 1.91 ng/mL on day 15 in the exaggerated dosing group. In the face-only group, the mean ± SD values of C _maxand AUC _0-24hof tazarotenic acid on day 15 were 0.10 ± 0.06 ng/mL and 1.54 ± 1.01 ng∙hr/mL, respectively, whereas in the 15% body surface area dosing group, the mean ± SD values of C _maxand AUC _0-24hof tazarotenic acid on day 15 were 1.20 ± 0.41 ng/mL and 17.01 ± 6.15 ng∙hr/mL, respectively. The steady state pharmacokinetics of tazarotenic acid had been reached by day 8 in the face-only and by day 15 in the 15% body surface area dosing groups.

In a Phase 3 clinical trial, tazarotene cream, 0.1% was applied once daily for 12 weeks to each of 48 subjects (22 females and 26 males) with facial acne vulgaris. The mean ± SD values of plasma tazarotenic acid at weeks 4 and 8 were 0.078 ± 0.073 ng/mL (N=47) and 0.052 ± 0.037 ng/mL (N=42), respectively. The highest observed individual plasma tazarotenic acid concentration was 0.41 ng/mL at week 4 from a female subject. The magnitude of plasma tazarotenic acid concentrations appears to be independent of gender, age, and body weight.

• Tazarotene cream 0.1% is a retinoid indicated for the topical treatment of plaque psoriasis. ( 1.1)
• Tazarotene cream 0.1% is indicated for the topical treatment of acne vulgaris. ( 1.2)

Tazarotene is a retinoid prodrug which is converted to its active form, the carboxylic acid of tazarotene, by deesterification. Tazarotenic acid binds to all three members of the retinoic acid receptor (RAR) family: RARα, RARβ, and RARγ, but shows relative selectivity for RARβ, and RARγ and may modify gene expression. The clinical significance of these findings is unknown.

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 [see Clinical Pharmacology (12.3)] .

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.

• Embryofetal Toxicity: Tazarotene cream contains tazarotene, which is a teratogenic substance. Tazarotene cream 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: Some individuals may experience excessive pruritus, burning, skin redness or peeling. If these effects occur, discontinue until the integrity of the skin has been restored, or reduce dosing interval, or in the case of psoriasis, may switch to the lower concentration. Tazarotene cream should not be used on eczematous skin, as it may cause severe irritation. ( 5.2)
• Photosensitivity and Risk for Sunburn: Avoid exposure to sunlight, sunlamps, and weather extremes. Wear sunscreen daily. Tazarotene cream should be administered with caution if the patient is also taking drugs known to be photosensitizers. ( 5.3)

• Apply a thin layer of tazarotene cream only to the affected area once daily in the evening. ( 2.1, 2.2)
• Not for ophthalmic, oral, or intravaginal use. ( 2.2)
• If contact with eyes occurs, rinse thoroughly with water. ( 2.2)

Cream, 0.1%. Each gram of tazarotene cream, 0.1% contains 1 mg of tazarotene in a white cream base.

The following adverse reactions have been identified during postapproval use of tazarotene. 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.

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.

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, tazarotene cream, 0.05% and 0.1% did not induce allergic contact sensitization, phototoxicity, or photoallergy.

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Tazarotene cream is a white cream available in a concentration of 0.1%. It is supplied in a collapsible aluminum tube with a tamper-evident aluminum membrane over the opening and a white polypropylene screw cap, in 30 g and 60 g sizes.

Tazarotene Cream, 0.1%

30 gram NDC 51672-1373-2

60 gram NDC 51672-1373-3

Tazarotene cream is for topical use only. Tazarotene cream is not for ophthalmic, oral, or intravaginal use. If contact with mucous membranes occurs, rinse thoroughly with water [see Warnings and Precautions (5.2)] . Wash hands thoroughly after application.

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 tazarotene cream. Patients must be warned to use sunscreens and protective clothing when using tazarotene cream. Patients with sunburn should be advised not to use tazarotene 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 tazarotene cream.

Tazarotene 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.

NDC 51672-1373-2

Tazarotene

Cream 0.1%

FOR DERMATOLOGICAL USE ONLY.

NOT FOR OPHTHALMIC USE.

Keep this and all medications out of the reach of children.

30 g

Rx only

Local tolerability reactions (including blistering and skin desquamation) and hypersensitivity adverse reactions (including urticaria) have been observed with topical tazarotene. Application of tazarotene 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 tazarotene cream is begun.

Tazarotene 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 tazarotene cream.