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warnings and cautions
5 WARNINGS AND PRECAUTIONS • Embryo-Fetal Toxicity : 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. ( 5.1 ) • Local Irritation : Some individuals may experience excessive pruritus, burning, skin redness, or peeling. If these adverse reactions occur, discontinue tazarotene cream until the integrity of the skin has been restored or reduce dosing interval. Avoid using tazarotene cream on eczematous skin, as such use may cause severe irritation. ( 5.2 ) • Photosensitivity and Risk of Sunburn : Avoid exposure to sunlight, sunlamps, and weather extremes. Wear sunscreen daily. Avoid using tazarotene cream if the patient is also taking drugs known to be photosensitizers. ( 5.3 ) • Lentigo Maligna : Carefully assess facial pigmented lesions of concern before application of tazarotene cream. ( 5.4 ) 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 )] Most common adverse events (occurring in ≥10% of patients) are desquamation, erythema, burning sensation, dry skin, skin irritation, and pruritus. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Fougera Pharmaceuticals Inc. at 1-800-645-9833 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 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. 6.2 Postmarketing Experience 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.