Australien - engelsk - Department of Health (Therapeutic Goods Administration)

ipsen pty ltd - palovarotene, quantity: 5 mg - capsule, hard - excipient ingredients: lactose monohydrate; povidone; microcrystalline cellulose; magnesium stearate; croscarmellose sodium; sodium lauryl sulfate; titanium dioxide; potable water; gelatin; propylene glycol; butan-1-ol; purified water; isopropyl alcohol; shellac; ethanol absolute; iron oxide black; ammonia; potassium hydroxide - sohonos is indicated to reduce the formation of heterotopic ossification in adults and children aged 8 years and above for females and 10 years and above for males with fibrodysplasia ossificans progressiva (fop).

Den Europæiske Union - engelsk - EMA (European Medicines Agency)

ipsen pharma - palovarotene - myositis ossificans - other drugs for disorders of the musculo-skeletal system - treatment of fibrodysplasia ossificans progressiva.

USA - engelsk - NLM (National Library of Medicine)

e. fougera & co. a division of fougera pharmaceuticals inc. - tazarotene (unii: 81bdr9y8ps) (tazarotene - unii:81bdr9y8ps) - 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 is contraindicated in : 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 cr

USA - engelsk - NLM (National Library of Medicine)

mayne pharma inc. - tazarotene (unii: 81bdr9y8ps) (tazarotene - unii:81bdr9y8ps) - tazarotene foam, 0.1% is indicated for the topical treatment of acne vulgaris in patients 12 years of age or older. tazarotene foam is contraindicated in pregnancy. tazarotene foam 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 [see use in specific populations (8.1, 8.3)]. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, treatment should be discontinued and the patient apprised of the potential hazard to the fetus [see warnings and precautions (5.1), use in specific populations (8.1, 8.3)]. risk summary based on data from animal reproduction studies, retinoid pharmacology, and the potential for systemic absorption, tazarotene foam 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 t

USA - engelsk - NLM (National Library of Medicine)

allergan, inc. - tazarotene (unii: 81bdr9y8ps) (tazarotene - unii:81bdr9y8ps) - tazarotene 0.5 mg in 1 g - tazorac® (tazarotene) gel, 0.05% and 0.1% are indicated for the topical treatment of patients with plaque psoriasis of up to 20% body surface area involvement. tazorac (tazarotene) gel, 0.1% is also indicated for the topical treatment of patients with facial acne vulgaris of mild to moderate severity. the efficacy of tazorac gel in the treatment of acne previously treated with other retinoids or resistant to oral antibiotics has not been established. the safety of tazorac gel use on more than 20% body surface area has not been established in psoriasis or acne [see warnings and precautions ( 5.1 ) and use in specific populations ( 8.1 )]. tazorac gel 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 )]. risk summary based on data from animal reproduction studies, ret

USA - engelsk - NLM (National Library of Medicine)

physicians total care, inc. - tazarotene (unii: 81bdr9y8ps) (tazarotene - unii:81bdr9y8ps) - tazarotene 1 mg in 1 g - tazorac® (tazarotene) gel 0.05% and 0.1% are indicated for the topical treatment of patients with stable plaque psoriasis of up to 20% body surface area involvement. tazorac® (tazarotene) gel 0.1% is also indicated for the topical treatment of patients with facial acne vulgaris of mild to moderate severity. the efficacy of tazorac® gel in the treatment of acne previously treated with other retinoids or resistant to oral antibiotics has not been established. retinoids may cause fetal harm when administered to a pregnant woman. in rats, tazarotene 0.05% gel, administered topically during gestation days 6 through 17 at 0.25 mg/kg/day (1.5 mg/m2 /day) resulted in reduced fetal body weights and reduced skeletal ossification. rabbits dosed topically with 0.25 mg/kg/day (2.75 mg/m2 total body surface area/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 daily

USA - engelsk - NLM (National Library of Medicine)

allergan, inc. - tazarotene (unii: 81bdr9y8ps) (tazarotene - unii:81bdr9y8ps) - tazarotene 1 mg in 1 g - avage (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: - avage cream does not eliminate or prevent wrinkles or restore more youthful skin. - avage cream does not reverse photoaging or repair sun damaged skin; avage 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 avage cream for the prevention or treatment of actinic keratoses, skin neoplasms, or lentigo maligna have not been established. avage 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 hypersen

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

mayne pharma international pty ltd - tazarotene -

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

mayne pharma international pty ltd - tazarotene -

USA - engelsk - NLM (National Library of Medicine)

bryant ranch prepack - tazarotene (unii: 81bdr9y8ps) (tazarotene - unii:81bdr9y8ps) - tazarotene gel, 0.05% and 0.1% are indicated for the topical treatment of patients with plaque psoriasis of up to 20% body surface area involvement. tazarotene gel, 0.1% is also indicated for the topical treatment of patients with facial acne vulgaris of mild to moderate severity. the efficacy of tazarotene gel in the treatment of acne previously treated with other retinoids or resistant to oral antibiotics has not been established. the safety of tazarotene gel use on more than 20% body surface area has not been established in psoriasis or acne [see warnings and precautions (5.1) and use in specific populations (8.1)] . tazarotene gel is contraindicated in: risk summary based on data from animal reproduction studies, retinoid pharmacology, and the potential for systemic absorption, tazarotene gel 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 gel during pregnancy; therefore, tazarotene gel 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 gel 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 0.5 times the maximum systemic exposure in subjects treated with the maximum recommended human dose (mrhd) of tazarotene gel, 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 7 times the maximum systemic exposure in subjects treated with the mrhd of tazarotene gel, 0.1%, there were single incidences 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 0.5 and 13 times, respectively, the maximum systemic exposure in subjects treated with the mrhd of tazarotene gel, 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 2 times higher than the maximum systemic exposure in subjects treated with the mrhd of tazarotene gel, 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 2-4% and 15-20%, 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 0.5 times the maximum systemic exposure in subjects treated with the mrhd of tazarotene gel, 0.1% (i.e., 2 mg/cm2 over a 20% 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 7 times the maximum systemic exposure in subjects treated with the mrhd of tazarotene gel, 0.1%, during gestation days 6 through 18 were noted with single incidences 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 producing 0.5 and 13 times, respectively, the maximum systemic exposure in subjects treated with the mrhd of tazarotene gel, 0.1%. in female rats orally administered 2 mg/kg/day of tazarotene from 15 days before mating through gestation day 7, which represented 2 times the maximum systemic exposure in subjects treated with the mrhd of tazarotene gel, 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 0.3 times the maximum systemic exposure in subjects treated with the mrhd of tazarotene gel, 0.1%. 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 14 c-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 gel 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 gel and any potential adverse effects on the breastfed child from tazarotene gel or from the underlying maternal condition. pregnancy testing pregnancy testing is recommended for females of reproductive potential within 2 weeks prior to initiating tazarotene gel therapy which should begin during a menstrual period. contraception females based on animal studies, tazarotene gel 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 gel. the safety and efficacy of tazarotene gel have not been established in pediatric patients with psoriasis or acne under the age of 12 years. of the total number of subjects in clinical trials of tazarotene gel for plaque psoriasis, 163 were over the age of 65. subjects over 65 years of age experienced more adverse events and lower treatment success rates after 12 weeks of use of tazarotene gel compared with those 65 years of age and younger. 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. tazarotene gel for the treatment of acne has not been clinically evaluated in persons over the age of 65.