Data from FDA - Curated by EPG Health - Last updated 25 January 2018

Indication(s)

1 INDICATIONS AND USAGE 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) 1.1 Plaque Psoriasis Tazarotene Cream, 0.1% is indicated for the topical treatment of patients with plaque psoriasis. 1.2 Acne Vulgaris Tazarotene Cream, 0.1% is also indicated for the topical treatment of patients with acne vulgaris.

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Advisory information

contraindications
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)] . Pregnancy ( 4, 8.1) Hypersensitivity ( 4)
Adverse reactions
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)] Plaque psoriasis: Most common adverse reactions occurring in 10 to 23% of patients are pruritus, erythema, and burning. ( 6.1) Acne Vulgaris: Most common adverse reactions occurring in 10 to 30% of patients are desquamation, dry skin, erythema, and burning sensation. ( 6.1) To report SUSPECTED ADVERSE REACTIONS, contact G&W Laboratories, Inc. at 1-800-922-1038 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. In human dermal safety trials, Tazarotene Cream, 0.1% did not induce allergic contact sensitization, phototoxicity, or photoallergy. Psoriasis The most frequent adverse reactions reported with Tazarotene 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. Tazarotene 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 Tazarotene Cream, 0.1% were 0.1 to 0.4% higher than those reported for Tazarotene Cream, 0.05%. Acne The most frequent adverse reactions reported during clinical trials with Tazarotene Cream, 0.1% in the treatment of acne, occurring in 10 to 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. 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.

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION 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) 2.1 Important Administration Instructions 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 Precaution ( 5.2)] . Wash hands thoroughly after application. 2.2 Psoriasis Apply a thin film (2 mg/cm 2) of Tazarotene Cream 0.1% 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. 2.3 Acne 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 Precaution ( 5.3)].
Use in special populations
8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary 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 during pregnancy; therefore, Tazarotene Cream should be discontinued as soon as pregnancy is recognized [see Contraindications ( 4), Warnings and Precautions ( 5.1), Clinical Pharmacology ( 12.3)]. Limited case reports of pregnancy in females enrolled in clinical trials for Tazarotene Cream have not established a clear association with tazarotene and major birth defects or miscarriage risk. Because the exact timing and extent of exposure in relation to the gestational age are not certain, the significance of these findings is unknown . In animal reproduction studies with pregnant rats, tazarotene dosed topically during organogenesis at 2 times the maximum systemic exposure in subjects treated with the maximum recommended human dose (MRHD) of tazarotene cream, 0.1% resulted in reduced fetal body weights and reduced skeletal ossification. In animal reproduction studies with pregnant rabbits dosed topically with tazarotene gel at 26 times the maximum systemic exposure in subjects treated with the MRHD of tazarotene cream, 0.1%, there was a single incident of known retinoid malformations, including spina bifida, hydrocephaly, and heart anomalies. In animal reproduction studies with pregnant rats and rabbits, tazarotene dosed orally during organogenesis at 2 and 52 times, respectively, the maximum systemic exposure in subjects treated with the MRHD of tazarotene cream, 0.1% resulted in malformations, fetal toxicity, developmental delays, and/or behavioral delays . In pregnant rats, tazarotene dosed orally prior to mating through early gestation resulted in decreased litter size, decreased numbers of live fetuses, decreased fetal body weights, and increased malformations at doses approximately 7 times higher than the maximum systemic exposure in subjects treated with the MRHD of tazarotene cream, 0.1% [see Data]. The background risk of major birth defects and miscarriage for the indicated population is unknown. Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In rats, a tazarotene gel, 0.05% formulation dosed topically during gestation days 6 through 17 at 0.25 mg/kg/day, which represented 2 times the maximum systemic exposure in subjects treated with the MRHD of tazarotene cream, 0.1% ( i.e., 2 mg/cm 2 over a 15% body surface area), resulted in reduced fetal body weights and reduced skeletal ossification. Rabbits dosed topically with 0.25 mg/kg/day tazarotene gel, which represented 26 times the maximum systemic exposure in subjects treated with MRHD of tazarotene cream, 0.1%, during gestation days 6 through 18, had a single incident of known retinoid malformations, including spina bifida, hydrocephaly, and heart anomalies. When tazarotene was given orally to animals, developmental delays were seen in rats, and malformations and post-implantation loss were observed in rats and rabbits at doses representing 2 and 52 times, respectively, the maximum systemic exposure seen in subjects treated with the MRHD of tazarotene cream, 0.1%. In female rats orally administered 2 mg/kg/day of tazarotene from 15 days before mating through gestation day 7, which represented 7 times the maximum systemic exposure in subjects treated with the MRHD of tazarotene cream, 0.1%, 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 was observed at that dose. In a pre-and postnatal development toxicity study, topical administration of tazarotene gel (0.125 mg/kg/day) to pregnant female rats from gestation day 16 through lactation day 20 reduced pup survival, but did not affect the reproductive capacity of the offspring. Based on data from another study, the maximum systemic exposure in the rat would be equivalent to the maximum systemic exposure in subjects treated with the MRHD of tazarotene cream, 0.1%. 8.2 Lactation Risk Summary There is no information regarding the presence of tazarotene in human milk, the effects on the breastfed infant, or the effects on milk production. After single topical doses of 14C-tazarotene gel to the skin of lactating rats, radioactivity was detected in rat milk. The lack of clinical data during lactation precludes a clear determination of the risk of Tazarotene Cream to an infant during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Tazarotene Cream and any potential adverse effects on the breastfed child from Tazarotene Cream or from the underlying maternal condition. 8.3 Females and Males of Reproductive Potential Pregnancy Testing Pregnancy testing is recommended for females of reproductive potential within 2 weeks prior to initiating Tazarotene Cream therapy which should begin during a menstrual period. Contraception Females Based on animal studies, Tazarotene Cream may cause fetal harm when administered to a pregnant woman [see Use in Specific Populations ( 8.1)]. Advise females of reproductive potential to use effective contraception during treatment with Tazarotene Cream. 8.4 Pediatric Use 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. 8.5 Geriatric Use 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.
Pregnancy and lactation
8.2 Lactation Risk Summary There is no information regarding the presence of tazarotene in human milk, the effects on the breastfed infant, or the effects on milk production. After single topical doses of 14C-tazarotene gel to the skin of lactating rats, radioactivity was detected in rat milk. The lack of clinical data during lactation precludes a clear determination of the risk of Tazarotene Cream to an infant during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Tazarotene Cream and any potential adverse effects on the breastfed child from Tazarotene Cream or from the underlying maternal condition.

Interactions

7 DRUG INTERACTIONS 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 max and AUC 0-24 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.

More information

Category Value
Authorisation number ANDA208662
Agency product number 81BDR9Y8PS
Orphan designation No
Product NDC 0713-0670
Date Last Revised 04-01-2018
Type HUMAN PRESCRIPTION DRUG
RXCUI 313200
Marketing authorisation holder G&W Laboratories, Inc.