Tazarotene Cream

TAZAROTENE CREAM- tazarotene cream
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

1 INDICATIONS AND USAGE

Tazarotene cream, 0.1% is indicated as an adjunctive agent for use in the mitigation (palliation) of facial fine wrinkling, facial mottled hyper- and hypopigmentation, and benign facial lentigines in patients who use comprehensive skin care and sunlight avoidance programs.

Limitations of Use :

Tazarotene cream does not eliminate or prevent wrinkles or restore more youthful skin.
Tazarotene cream does not reverse photoaging or repair sun damaged skin; tazarotene cream does not mitigate coarse or deep wrinkling, tactile roughness, telangiectasia, skin laxity, keratinocytic atypia, melanocytic atypia, or dermal elastosis.
The safety and the effectiveness of tazarotene cream for the prevention or treatment of actinic keratoses, skin neoplasms, or lentigo maligna have not been established.

2 DOSAGE AND ADMINISTRATION

2.1 Assessment Prior to Treatment Initiation

Obtain a pregnancy test within 2 weeks prior to tazarotene cream therapy. Initiate tazarotene cream therapy during a menstrual period [see Contraindications (4), Warnings and Precautions (5.1), and Use in Specific Populations (8.1, 8.3)].

Carefully assess facial pigmented lesions of concern by a qualified physician (e.g., dermatologist) before application of tazarotene cream [see Warnings and Precautions (5.4)].

2.2 Important Administration Instructions

Avoid accidental transfer of tazarotene cream into eyes, mouth, or other mucous membranes. If contact with mucous membranes occurs, rinse thoroughly with water [see Warnings and Precaution (5.2)].

Wash hands thoroughly after application.

Emollients or moisturizers can be applied either before or after applying tazarotene cream. However, ensure that the first cream or lotion has absorbed into the skin and has dried completely before subsequent cream or lotion application. Use facial moisturizers as frequently as desired [see Warnings and Precaution (5.2)].

Tazarotene cream is for topical use only. Tazarotene cream is not for ophthalmic, oral, or intravaginal use.

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

2.3 Dosage and Administration Instructions

Remove any makeup before applying tazarotene cream to the face. Dry the skin before applying the cream after face washing, bathing, or showering.

Apply a pea-sized amount once a day at bedtime to lightly cover the entire face, including the eyelids, if desired.

Wash hands thoroughly after application.

3 DOSAGE FORMS AND STRENGTHS

Cream: 1 mg of tazarotene per gram (0.1%) of white cream in 30 gram tubes.

4 CONTRAINDICATIONS

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)].

5 WARNINGS AND PRECAUTIONS

5.1 Embryofetal Toxicity

Based on data from animal reproduction studies, retinoid pharmacology and the potential for systemic absorption, tazarotene cream 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 from tazarotene cream use during pregnancy; therefore, discontinue tazarotene cream as soon as pregnancy is recognized. Tazarotene elicits malformations and developmental effects associated with retinoids after topical and oral administration to pregnant rats and rabbits during organogenesis. However, limited case reports of pregnancy in females enrolled in clinical trials for tazarotene cream have not reported a clear association with tazarotene and major birth defects or miscarriage risk [see Contraindications (4), Use in Specific Populations (8.1)].

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 these orally treated animals. Although there may be less systemic exposure in the treatment of the face alone due to less surface area for application, tazarotene is a teratogenic substance in animals, and it is not known what level of exposure is required for teratogenicity in humans [see Clinical Pharmacology (12.3)].

Advise pregnant females of the potential risk to a fetus. Obtain a pregnancy test within 2 weeks prior to tazarotene cream therapy. Initiate tazarotene cream therapy during a menstrual period. Advise females of reproductive potential to use effective contraception during treatment with tazarotene cream [see Dosage and Administration (2), Use in Specific Populations (8.3)].

5.2 Local Irritation and Hypersensitivity Reactions

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 adverse reactions occur, discontinue the medication until the integrity of the skin is restored, or reduce the dosing to an interval the patient can tolerate. Closely monitor the frequency of application by carefully observing the therapeutic response and skin tolerance.

Avoid concomitant use of topical medications and cosmetics that have a strong drying effect. It is also advisable to “rest” a patient’s skin until the effects of such preparations subside before use of tazarotene cream is begun.

Avoid using tazarotene cream on eczematous skin because such use may cause severe irritation.

Weather extremes, such as wind or cold, may be more irritating to patients using tazarotene cream.

5.3 Photosensitivity and Risk of Sunburn

Because of heightened burning susceptibility, minimize exposure to ultraviolet rays (including sunlight and sun lamps) during the use of tazarotene cream. Patients must be warned to use sunscreens and protective clothing when using tazarotene cream. Advise patients with sunburn not to use tazarotene cream until the sunburn is fully recovered.

Patients who may have considerable sun exposure because of their occupation and those patients with inherent sensitivity to sunlight should exercise particular caution when using tazarotene cream.

Avoid using tazarotene cream 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.

5.4 Lentigo Maligna

Some facial pigmented lesions are not lentigines, but rather lentigo maligna, a type of melanoma. Before application of tazarotene cream, carefully assess facial pigmented lesions of concern by a qualified physician (e.g., dermatologist) to exclude a diagnosis of lentigo maligna.

6 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)]

6.1 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.

The most frequent adverse reactions reported with tazarotene cream, 0.1% that occurred in greater than 10% of subjects, included desquamation, erythema, burning sensation, and dry skin (in descending order). Reactions that occurred in 1 to 10% of subjects, included skin irritation, pruritus, irritant contact dermatitis, stinging, rash, and cheilitis (in descending order). Common adverse events that occurred at a rate of at least 1% and at a higher rate in the tazarotene cream group than in the vehicle group in the clinical trials are presented in the following table.

TABLE OF ADVERSE EVENTS SEEN IN 24-WEEK CLINICAL TRIALS WITH TAZAROTENE CREAM, 0.1%

Adverse Event

Tazarotene N=567

Vehicle N=564

Desquamation

40%

3%

Erythema

34%

3%

Burning Sensation

26%

<1%

Dry Skin

16%

3%

Irritation Skin

10%

1%

Pruritus

10%

1%

Irritant Contact Dermatitis

8%

1%

Stinging

3%

<1%

Rash

3%

1%

Cheilitis

1%

0%

A few subjects reported adverse events at Week 0; however, for patients who were treated with tazarotene cream, the highest number of new reports for each adverse event was at Week 2.

When combining data from the two trials, 5.3% of subjects in the tazarotene cream group and 0.9% of subjects in the vehicle group discontinued because of adverse events.

Overall, 20/567 (3.5%) subjects in the tazarotene cream group and 16/564 (2.8%) subjects in the vehicle group reported adverse events (including edema, irritation, and inflammation) directly related to the eye or eyelid. The majority of these conditions were mild.

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