United States - English - NLM (National Library of Medicine)

janssen biotech, inc. - abiraterone acetate (unii: em5ocb9yj6) (abiraterone - unii:g819a456d0) - abiraterone acetate is indicated in combination with prednisone for the treatment of patients with - metastatic castration-resistant prostate cancer (crpc) - metastatic high-risk castration-sensitive prostate cancer (cspc) none. risk summary the safety and efficacy of abiraterone acetate have not been established in females. based on findings from animal studies and the mechanism of action, abiraterone acetate can cause fetal harm and potential loss of pregnancy. there are no human data on the use of abiraterone acetate in pregnant women. in animal reproduction studies, oral administration of abiraterone acetate to pregnant rats during organogenesis caused adverse developmental effects at maternal exposures approximately ≥ 0.03 times the human exposure (auc) at the recommended dose (see data). data animal data in an embryo-fetal developmental toxicity study in rats, abiraterone acetate caused developmental toxicity when administered at oral doses of 10, 30 or 100 mg/kg/day throughout the period of organogene

Canada - English - Health Canada

apotex inc - abiraterone acetate - tablet - 500mg - abiraterone acetate 500mg - antineoplastic agents

Australia - English - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - abiraterone acetate, quantity: 500 mg - tablet, film coated - excipient ingredients: lactose monohydrate; croscarmellose sodium; sodium lauryl sulfate; silicified microcrystalline cellulose; hypromellose; magnesium stearate; silicon dioxide; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - zytiga is indicated in combination with prednisone or prednisolone for the treatment of: ? newly diagnosed high-risk metastatic hormone sensitive prostate cancer (mhspc) in combination with androgen deprivation therapy (adt), or ? patients with metastatic advanced prostate cancer (castration resistant prostate cancer, mcrpc) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (adt) or ? patients with mcrpc who have received prior chemotherapy containing a taxane.

Malta - English - Malta Medicines Authority

heaton k.s. na pankraci 14, 140 00 praha 4, czech republic - abiraterone acetate - film-coated tablet - abiraterone acetate 500 mg - endocrine therapy

United States - English - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - abiraterone acetate (unii: em5ocb9yj6) (abiraterone - unii:g819a456d0) - abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with none. the safety and efficacy of abiraterone acetate tablets have not been established in females. based on findings from animal studies and the mechanism of action, abiraterone acetate tablets can cause fetal harm and potential loss of pregnancy. there are no human data on the use of abiraterone acetate tablets in pregnant women. in animal reproduction studies, oral administration of abiraterone acetate to pregnant rats during organogenesis caused adverse developmental effects at maternal exposures approximately ≥ 0.03 times the human exposure (auc) at the recommended dose (see data). in an embryo-fetal developmental toxicity study in rats, abiraterone acetate caused developmental toxicity when administered at oral doses of 10, 30 or 100 mg/kg/day throughout the period of organogenesis (gestational days 6-17). findings included embryo-fetal lethality (increased post implantation loss and resorptions an

Israel - English - Ministry of Health

abic marketing ltd, israel - abiraterone acetate - tablets - abiraterone acetate 500 mg - abiraterone - abiraterone teva is indicated:1. in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer.2. for the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt).

United States - English - NLM (National Library of Medicine)

glenmark pharmaceuticals inc., usa - abiraterone acetate (unii: em5ocb9yj6) (abiraterone - unii:g819a456d0) - abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with none. risk summary the safety and efficacy of abiraterone acetate have not been established in females. based on findings from animal studies and the mechanism of action, abiraterone acetate can cause fetal harm and potential loss of pregnancy. there are no human data on the use of abiraterone acetate in pregnant women. in animal reproduction studies, oral administration of abiraterone acetate to pregnant rats during organogenesis caused adverse developmental effects at maternal exposures approximately ≥ 0.03 times the human exposure (auc) at the recommended dose (see data). data animal data in an embryo-fetal developmental toxicity study in rats, abiraterone acetate caused developmental toxicity when administered at oral doses of 10, 30 or 100 mg/kg/day throughout the period of organogenesis (gestational days 6 to 17). findings included embryo-fetal lethality (increased post implantation loss and resorptions and decreased number of live fetuses), fetal developmental delay (skeletal effects) and urogenital effects (bilateral ureter dilation) at doses ≥ 10 mg/kg/day, decreased fetal ano-genital distance at ≥ 30 mg/kg/day, and decreased fetal body weight at 100 mg/kg/day. doses ≥ 10 mg/kg/day caused maternal toxicity. the doses tested in rats resulted in systemic exposures (auc) approximately 0.03, 0.1 and 0.3 times, respectively, the auc in patients. risk summary the safety and efficacy of abiraterone acetate have not been established in females. there is no information available on the presence of abiraterone in human milk, or on the effects on the breastfed child or milk production. contraception males based on findings in animal reproduction studies and its mechanism of action, advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 weeks after the final dose of abiraterone acetate [see use in specific populations (8.1)]. infertility based on animal studies, abiraterone acetate may impair reproductive function and fertility in males of reproductive potential [see nonclinical toxicology (13.1)]. safety and effectiveness of abiraterone acetate in pediatric patients have not been established. of the total number of patients receiving abiraterone acetate in randomized clinical trials, 70% of patients were 65 years and over and 27% were 75 years and over. no overall differences in safety or effectiveness were observed between these elderly patients and younger patients. other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. the pharmacokinetics of abiraterone were examined in subjects with baseline mild (n=8) or moderate (n=8) hepatic impairment (child-pugh class a and b, respectively) and in 8 healthy control subjects with normal hepatic function. the systemic exposure (auc) of abiraterone after a single oral 1,000 mg dose of abiraterone acetate increased by approximately 1.1-fold and 3.6-fold in subjects with mild and moderate baseline hepatic impairment, respectively compared to subjects with normal hepatic function. in another trial, the pharmacokinetics of abiraterone were examined in subjects with baseline severe (n=8) hepatic impairment (child-pugh class c) and in 8 healthy control subjects with normal hepatic function. the systemic exposure (auc) of abiraterone increased by approximately 7-fold and the fraction of free drug increased 2-fold in subjects with severe baseline hepatic impairment compared to subjects with normal hepatic function. no dosage adjustment is necessary for patients with baseline mild hepatic impairment. in patients with baseline moderate hepatic impairment (child-pugh class b), reduce the recommended dose of abiraterone acetate to 250 mg once daily. do not use abiraterone acetate in patients with baseline severe hepatic impairment (child-pugh class c). if elevations in alt or ast > 5 × uln or total bilirubin > 3 × uln occur in patients with baseline moderate hepatic impairment, discontinue abiraterone acetate treatment [see dosage and administration (2.4) and clinical pharmacology (12.3)]. for patients who develop hepatotoxicity during treatment, interruption of treatment and dosage adjustment may be required [see dosage and administration (2.4), warnings and precautions (5.3), and clinical pharmacology (12.3)]. no dosage adjustment is necessary for patients with renal impairment [see clinical pharmacology (12.3)].

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - abiraterone acetate 500mg - film coated tablet - 500 mg - active: abiraterone acetate 500mg excipient: colloidal silicon dioxide croscarmellose sodium hypromellose lactose monohydrate magnesium stearate microcrystalline cellulose opadry purple 85f90093 sodium laurilsulfate - zytiga is indicated in combination with prednisone or prednisolone and androgen depreviation therapy (adt) for the treatment of high-risk metastatic hormone naive prostate cancer (mhnpc) or newly diagnosed high-risk metastatic hormone sensitive prostate cancer (mhspc) zytiga is also indicated with prednisone or prednisolone for: . the treatment of patients with metastatic castration resistant prostate cancer (mcprc) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (adt) in whom chemotherapy is not yet clinically indicated . the treatment of patients with metastatic advanced prostate cancer (castration resistant prostate cancer, mcprc) who have received prior chemotherapy containing a taxane.

Australia - English - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - abiraterone acetate, quantity: 500 mg - tablet, film coated - excipient ingredients: lactose monohydrate; croscarmellose sodium; sodium lauryl sulfate; silicified microcrystalline cellulose; hypromellose; magnesium stearate; silicon dioxide; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - janssen abiraterone is indicated in combination with prednisone or prednisolone for the treatment of: ? newly diagnosed high-risk metastatic hormone sensitive prostate cancer (mhspc) in combination with androgen deprivation therapy (adt), or ? patients with metastatic advanced prostate cancer (castration resistant prostate cancer, mcrpc) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (adt) or ? patients with mcrpc who have received prior chemotherapy containing a taxane.

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

eg sa-nv - abiraterone acetate 500 mg - film-coated tablet - 500 mg - abiraterone acetate 500 mg - abiraterone