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

pharmaand gmbh - rucaparib camsylate (unii: 41ax9sj8ko) (rucaparib - unii:8237f3u7eh) - rubraca is indicated for the maintenance treatment of adult patients with a deleterious brca mutation (germline and/or somatic)- associated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. rubraca is indicated for the treatment of adult patients with a deleterious brca mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mcrpc) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. select patients for therapy based on an fda-approved companion diagnostic for rubraca [see dosage and administration ( 2.1)]. this indication is approved under accelerated approval based on objective response rate and duration of response [see clinical studies ( 14.2)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. none. risk summary based on findings from animal studies and its mechanism of action, rubraca can cause fetal harm when administered to pregnant women. there are no available data in pregnant women to inform the drug-associated risk. in an animal reproduction study, administration of rucaparib to pregnant rats during organogenesis resulted in embryo-fetal death at maternal exposures that were 0.04 times the auc 0-24h in patients receiving the recommended dose of 600 mg twice daily [see data] . apprise pregnant women of the potential risk to a fetus. the background risk of major birth defects and miscarriage for the indicated population is unknown. 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 a dose range-finding embryo-fetal development study, pregnant rats received oral doses of 50, 150, 500, or 1000 mg/kg/day of rucaparib during the period of organogenesis. post-implantation loss (100% early resorptions) was observed in all animals at doses greater than or equal to 50 mg/kg/day (with maternal systemic exposures approximately 0.04 times the human exposure at the recommended dose based on auc 0-24h ). risk summary there is no information regarding the presence of rucaparib in human milk, or on its effects on milk production or the breast-fed child. because of the potential for serious adverse reactions in breast-fed children from rubraca, advise lactating women not to breastfeed during treatment with rubraca and for 2 weeks following the last dose. rubraca can cause fetal harm when administered to a pregnant woman [see use in specific populations ( 8.1)] . pregnancy testing pregnancy testing is recommended for females of reproductive potential prior to initiating rubraca. contraception females advise females of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of rubraca [see use in specific populations ( 8.1)] . males based on findings in genetic toxicity and animal reproduction studies, advise male patients with female partners of reproductive potential or who are pregnant to use effective methods of contraception during treatment and for 3 months following last dose of rubraca. advise male patients not to donate sperm during therapy and for 3 months following the last dose of rubraca [see use in specific populations ( 8.1) and nonclinical toxicology ( 13.1)]. the safety and effectiveness of rubraca in pediatric patients have not been established. of the 937 patients with ovarian cancer who received rubraca in clinical trials including ariel3, 41% were age 65 or older and 10% were 75 years or older. no major differences in safety were observed between younger and older patients with ovarian cancer. of the 209 patients with mcrpc who received rubraca in triton2, 77% were age 65 or older and 33% were 75 years or older. no major differences in safety were observed between younger and older patients with mcrpc. no dosage modification is recommended for patients with mild to moderate renal impairment (creatinine clearance [clcr] between 30 and 89 ml/min, as estimated by the cockcroft-gault method) [see clinical pharmacology ( 12.3)]. rubraca has not been studied in patients with clcr < 30 ml/min or patients on dialysis. no dosage modification is recommended for patients with mild to moderate hepatic impairment (total bilirubin ≤ 3 x upper limit of normal [uln] or ast > uln) [see clinical pharmacology ( 12.3)] . rubraca has not been studied in patients with severe hepatic impairment (total bilirubin > 3 x uln and any ast).

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

astrazeneca pharmaceuticals lp - olaparib (unii: woh1jd9ar8) (olaparib - unii:woh1jd9ar8) - olaparib 50 mg - lynparza is indicated for the treatment of adult patients with deleterious or suspected deleterious germline brca -mutated (gbrcam ) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. select patients for therapy based on an fda-approved companion diagnostic for lynparza. none. risk summary based on findings in animals and its mechanism of action [see clinical pharmacology (12.1)] , lynparza can cause fetal harm when administered to a pregnant woman. there are no available data on lynparza use in pregnant women to inform the drug associated risk. in an animal reproduction study, the administration of olaparib to pregnant rats during the period of organogenesis caused teratogenicity and embryo-fetal toxicity at exposures below those in patients receiving the recommended human dose of 400 mg twice daily [see data] . apprise pregnant women of the potential hazard to the fetus and the potential risk for loss of the pregnancy. the estimated background risk of major birth d

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

astrazeneca pharmaceuticals lp - olaparib (unii: woh1jd9ar8) (olaparib - unii:woh1jd9ar8) - olaparib 100 mg - lynparza is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic brca -mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. select patients for therapy based on an fda-approved companion diagnostic for lynparza [see dosage and administration (2.1) ] . lynparza is indicated in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (hrd)-positive status defined by either: select patients for therapy based on an fda-approved companion diagnostic for lynparza [see dosage and administration (2.1)]. lynparza is indicated for the maintenance treatment of adult patients with deleterious or su

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)

bluebird bio (netherlands) b.v. - autologous cd34+ cell enriched population that contains hematopoietic stem cells transduced with lentiglobin bb305 lentiviral vector encoding the beta-a-t87q-globin gene - beta-thalassemia - other hematological agents - zynteglo is indicated for the treatment of patients 12 years and older with transfusion-dependent β thalassaemia (tdt) who do not have a β0/β0 genotype, for whom haematopoietic stem cell (hsc) transplantation is appropriate but a human leukocyte antigen (hla)-matched related hsc donor is not available.

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

glaxosmithkline llc - niraparib (unii: hmc2h89n35) (niraparib - unii:hmc2h89n35) - zejula is indicated for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy. zejula is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline brca -mutated (gbrca mut) recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. select patients for therapy based on an fda-approved companion diagnostic for zejula [see dosage and administration (2.1)] . none. risk summary based on its mechanism of action, zejula can cause fetal harm when administered to pregnant women [see clinical pharmacology (12.1)] . there are no data regarding the use of zejula in pregnant women to inform the drug-associated risk. zejula has the potential to cause teratogenicity and/or embryo-fetal death since niraparib is genotoxic and targets actively dividing cells in animals and patients (e.g., bone marrow) [see warnings and precautions (5.2), nonclinical toxicology (13.1)] . due to the potential risk to a fetus based on its mechanism of action, animal developmental and reproductive toxicology studies were not conducted with niraparib. apprise pregnant women of the potential risk to a fetus. the background risk of major birth defects and miscarriage for the indicated population is unknown. 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. risk summary no data are available regarding the presence of niraparib or its metabolites in human milk, or on its effects on the breastfed child or milk production. because of the potential for serious adverse reactions in a breastfed child, advise a lactating woman not to breastfeed during treatment with zejula and for 1 month after receiving the last dose. zejula can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . pregnancy testing verify the pregnancy status of females of reproductive potential prior to initiating treatment with zejula. contraception females: advise females of reproductive potential to use effective contraception during treatment with zejula and for 6 months following the last dose. infertility males: based on animal studies, zejula may impair fertility in males of reproductive potential [see nonclinical toxicology (13.1)] . the safety and effectiveness of zejula have not been established in pediatric patients. in prima, 39% of patients were aged 65 years or older and 10% were aged 75 years or older. in nova, 35% of patients were aged 65 years or older and 8% were aged 75 years or older. no overall differences in safety and effectiveness of zejula were observed between these patients and younger patients but greater sensitivity of some older individuals cannot be ruled out. no dose adjustment is necessary for patients with mild (clcr: 60 to 89 ml/min) to moderate (clcr: 30 to 59 ml/min) renal impairment. the degree of renal impairment was determined by creatinine clearance as estimated by the cockcroft-gault equation. the safety of zejula in patients with severe renal impairment or end-stage renal disease undergoing hemodialysis is unknown. for patients with moderate hepatic impairment, reduce the starting dosage of niraparib to 200 mg once daily [see dosage and administration (2.4)]. niraparib exposure increased in patients with moderate hepatic impairment [total bilirubin ≥1.5 x upper level of normal (uln) to 3.0 x uln and any aspartate transaminase (ast) level]. monitor patients for hematologic toxicity and reduce the dose further, if needed [see dosage and administration (2.3)] . for patients with mild hepatic impairment (total bilirubin <1.5 x uln and any ast level or bilirubin ≤ uln and ast > uln), no dose adjustment is needed. the recommended dose of zejula has not been established for patients with severe hepatic impairment (total bilirubin >3.0 x uln and any ast level) [see clinical pharmacology (12.3)] .

Canada - English - Health Canada

novartis pharmaceuticals canada inc - voretigene neparvovec - solution - 5000000000000vg - voretigene neparvovec 5000000000000vg - cellular and gene therapy

European Union - English - EMA (European Medicines Agency)

bluebird bio (netherlands) b.v. - elivaldogene autotemcel - adrenoleukodystrophy - other nervous system drugs - treatment of early cerebral adrenoleukodystrophy in patients less than 18 years of age, with an abcd1 genetic mutation, and for whom a human leukocyte antigen (hla) matched sibling haematopoietic stem cell donor is not available.

Singapore - English - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - niraparib tosylate monohydrate eqv niraparib - tablet, film coated - niraparib tosylate monohydrate eqv niraparib 100mg