Singapore - English - HSA (Health Sciences Authority)

pfizer private limited - talazoparib tosylate eqv talazoparib - capsule - talazoparib tosylate eqv talazoparib 0.25 mg

Singapore - English - HSA (Health Sciences Authority)

pfizer private limited - talazoparib tosylate eqv talazoparib - capsule - talazoparib tosylate eqv talazoparib 1 mg

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - talazoparib as tosylate - hard capsule - talazoparib as tosylate 0.25 mg - talazoparib - talzenna is indicated for the treatment of adult patients with deleterious or suspected deleterious germline breast cancer susceptibility gene (brca) mutated (gbrcam) human epidermal growth factor receptor 2 (her2) negative locally advanced or metastatic breast cancer.

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - talazoparib as tosylate - hard capsule - talazoparib as tosylate 1 mg - talazoparib - talzenna is indicated for the treatment of adult patients with deleterious or suspected deleterious germline breast cancer susceptibility gene (brca) mutated (gbrcam) human epidermal growth factor receptor 2 (her2) negative locally advanced or metastatic breast cancer.

Canada - English - Health Canada

pfizer canada ulc - talazoparib (talazoparib tosylate) - capsule - 0.25mg - talazoparib (talazoparib tosylate) 0.25mg - antineoplastic agents

Canada - English - Health Canada

pfizer canada ulc - talazoparib (talazoparib tosylate) - capsule - 1mg - talazoparib (talazoparib tosylate) 1mg - antineoplastic agents

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

pfizer laboratories div pfizer inc - talazoparib tosylate (unii: 02wk9u5nzc) (talazoparib - unii:9qhx048frv) -       talzenna is indicated as a single agent for the treatment of adult patients with deleterious or suspected deleterious germline breast cancer susceptibility gene (brca )-mutated (gbrca m) human epidermal growth factor receptor 2 (her2)-negative locally advanced or metastatic breast cancer. select patients for therapy based on an fda-approved companion diagnostic for talzenna [see dosage and administration (2.1)] . talzenna is indicated in combination with enzalutamide for the treatment of adult patients with homologous recombination repair (hrr) gene-mutated metastatic castration-resistant prostate cancer (mcrpc) [see dosage and administration (2.3)] . none. risk summary based on findings from animal studies and its mechanism of action [see clinical pharmacology (12.1)] , talzenna can cause embryo-fetal harm when administered to a pregnant woman. there are no available data on talzenna use in pregnant women to inform a drug-associated risk. in an animal reproduction study, the administration of talazoparib to pregnant rats during the period of organogenesis caused fetal malformations and structural skeletal variations and embryo-fetal death at maternal exposures that were 0.24 times the auc in patients receiving the recommended dose of 1 mg daily (see data) . apprise pregnant women and females of reproductive potential of the potential risk to a fetus. the background risk of major birth defects and miscarriage for the indicated population is unknown. in the general u.s. population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively. data animal data in an embryo-fetal development toxicity study, pregnant rats received oral doses of 0.015, 0.05, and 0.15 mg/kg/day talazoparib during the period of organogenesis. talazoparib caused embryo-fetal death at doses ≥0.015 mg/kg/day (approximately 0.24 times the auc in patients at the recommended dose of 1 mg daily). a dose of 0.015 mg/kg/day caused decreased fetal body weights and an increased incidence of fetal malformations (depressed eye bulge, small eye, split sternebra, and fused cervical vertebral arch) and structural variations including misshapen or incomplete ossification of the sternebra, skull, rib, and vertebra. risk summary there are no data on the presence of talazoparib in human milk, the effects of the drug on milk production, or the effects of the drug on the breastfed child. because of the potential for serious adverse reactions in a breastfed child from talazoparib, advise lactating women not to breastfeed during treatment with talzenna and for 1 month after the final dose. talzenna can cause fetal harm when administered to pregnant women [see use in specific populations (8.1)] . pregnancy testing verify pregnancy status in females of reproductive potential prior to initiating talzenna treatment. contraception females advise females of reproductive potential to use effective contraception during treatment and for 7 months following the last dose of talzenna. males based on genotoxicity and animal reproduction studies, advise male patients with female partners of reproductive potential and pregnant partners to use effective contraception during treatment with talzenna and for 4 months following the last dose [see use in specific populations (8.1), nonclinical toxicology (13.1)] . infertility males based on animal studies, talzenna may impair fertility in males of reproductive potential [see nonclinical toxicology (13.1)]. the safety and effectiveness of talzenna have not been established in pediatric patients. in clinical trials of talzenna enrolling 494 patients with advanced solid tumors who received talzenna 1 mg daily as a single agent, 85 (17%) patients were ≥65 years of age, and this included 19 (4%) patients who were ≥75 years old. there were 5 patients ≥85 years old. in the talapro-2 trial, of 197 patients who received talzenna, 77% were ≥65 years of age, while 30% were ≥75 years of age. no overall differences in safety or effectiveness of talzenna were observed between these patients and younger patients. no dosage modification is recommended for patients with hepatic impairment [see clinical pharmacology (12.3)] . reduce the recommended dosage of talzenna in patients with moderate (clcr 30 – 59 ml/min) and severe (clcr 15 – 29 ml/min) renal impairment [see dosage and administration (2.7)] . monitor patients with severe renal impairment for increased adverse reactions and modify the dosage as recommended for adverse reactions [see dosage and administration (2.5)] . no dose adjustment is recommended for patients with mild renal impairment (clcr 60 – 89 ml/min). talzenna has not been studied in patients requiring hemodialysis.

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

u.s. pharmaceuticals - talazoparib tosylate (unii: 02wk9u5nzc) (talazoparib - unii:9qhx048frv) -       talzenna is indicated as a single agent for the treatment of adult patients with deleterious or suspected deleterious germline breast cancer susceptibility gene (brca )-mutated (gbrca m) human epidermal growth factor receptor 2 (her2)-negative locally advanced or metastatic breast cancer. select patients for therapy based on an fda-approved companion diagnostic for talzenna [see dosage and administration (2.1)] . talzenna is indicated in combination with enzalutamide for the treatment of adult patients with homologous recombination repair (hrr) gene-mutated metastatic castration-resistant prostate cancer (mcrpc) [see dosage and administration (2.3)] . none. risk summary based on findings from animal studies and its mechanism of action [see clinical pharmacology (12.1)] , talzenna can cause embryo-fetal harm when administered to a pregnant woman. there are no available data on talzenna use in pregnant women to inform a drug-associated risk. in an animal reproduction study, the administration of talazoparib to pregnant rats during the period of organogenesis caused fetal malformations and structural skeletal variations and embryo-fetal death at maternal exposures that were 0.24 times the auc in patients receiving the recommended dose of 1 mg daily (see data) . apprise pregnant women and females of reproductive potential of the potential risk to a fetus. the background risk of major birth defects and miscarriage for the indicated population is unknown. in the general u.s. population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively. data animal data in an embryo-fetal development toxicity study, pregnant rats received oral doses of 0.015, 0.05, and 0.15 mg/kg/day talazoparib during the period of organogenesis. talazoparib caused embryo-fetal death at doses ≥0.015 mg/kg/day (approximately 0.24 times the auc in patients at the recommended dose of 1 mg daily). a dose of 0.015 mg/kg/day caused decreased fetal body weights and an increased incidence of fetal malformations (depressed eye bulge, small eye, split sternebra, and fused cervical vertebral arch) and structural variations including misshapen or incomplete ossification of the sternebra, skull, rib, and vertebra. risk summary there are no data on the presence of talazoparib in human milk, the effects of the drug on milk production, or the effects of the drug on the breastfed child. because of the potential for serious adverse reactions in a breastfed child from talazoparib, advise lactating women not to breastfeed during treatment with talzenna and for 1 month after the final dose. talzenna can cause fetal harm when administered to pregnant women [see use in specific populations (8.1)] . pregnancy testing verify pregnancy status in females of reproductive potential prior to initiating talzenna treatment. contraception females advise females of reproductive potential to use effective contraception during treatment and for 7 months following the last dose of talzenna. males based on genotoxicity and animal reproduction studies, advise male patients with female partners of reproductive potential and pregnant partners to use effective contraception during treatment with talzenna and for 4 months following the last dose [see use in specific populations (8.1), nonclinical toxicology (13.1)] . infertility males based on animal studies, talzenna may impair fertility in males of reproductive potential [see nonclinical toxicology (13.1)]. the safety and effectiveness of talzenna have not been established in pediatric patients. in clinical trials of talzenna enrolling 494 patients with advanced solid tumors who received talzenna 1 mg daily as a single agent, 85 (17%) patients were ≥65 years of age, and this included 19 (4%) patients who were ≥75 years old. there were 5 patients ≥85 years old. in the talapro-2 trial, of 197 patients who received talzenna, 77% were ≥65 years of age, while 30% were ≥75 years of age. no overall differences in safety or effectiveness of talzenna were observed between these patients and younger patients. no dosage modification is recommended for patients with hepatic impairment [see clinical pharmacology (12.3)] . reduce the recommended dosage of talzenna in patients with moderate (clcr 30 – 59 ml/min) and severe (clcr 15 – 29 ml/min) renal impairment [see dosage and administration (2.7)] . monitor patients with severe renal impairment for increased adverse reactions and modify the dosage as recommended for adverse reactions [see dosage and administration (2.5)] . no dose adjustment is recommended for patients with mild renal impairment (clcr 60 – 89 ml/min). talzenna has not been studied in patients requiring hemodialysis.

European Union - English - EMA (European Medicines Agency)

pfizer europe ma eeig - talazoparib - breast neoplasms - antineoplastic agents - talzenna is indicated as monotherapy for the treatment of adult patients with germline brca1/2 mutations, who have her2-negative locally advanced or metastatic breast cancer. patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. patients with hormone receptor (hr)-positive breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for endocrine-based therapy.

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

pfizer (malaysia) sdn. bhd. - talazoparib tosylate -