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

nanjing chemlin biomedical science & technology co, ltd. - olaparib (unii: woh1jd9ar8) (olaparib - unii:woh1jd9ar8) -

Kenya - English - Pharmacy and Poisons Board

beacon medicare limited 9/b/2, toyenbee circular road, motijheel, - olaparib inn - tablet - olaparib inn 150mg - olaparib

European Union - English - EMA (European Medicines Agency)

pharmaand gmbh - rucaparib camsylate - ovarian neoplasms - antineoplastic agents - rubraca is indicated as monotherapy for the maintenance treatment of adult patients with advanced (figo stages iii and iv) high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.rubraca is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.

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)] .

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

glaxosmithkline llc - niraparib tosylate monohydrate (unii: 195q483uzd) (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 (gbrcamut) 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)] .

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

glaxosmithkline australia pty ltd - niraparib tosilate monohydrate, quantity: 159.4 mg (equivalent: niraparib, qty 100 mg) - capsule, hard - excipient ingredients: lactose monohydrate; gelatin; magnesium stearate; titanium dioxide; erythrosine; tartrazine; brilliant blue fcf; propylene glycol; ethanol; isopropyl alcohol; shellac; povidone; tert-butyl alcohol; sodium hydroxide; butan-1-ol; purified water; ethanol absolute; iron oxide black; ammonia; potassium hydroxide - for the maintenance treatment of adult patients with advanced high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.,as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.

European Union - English - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - niraparib (tosilate monohydrate) - fallopian tube neoplasms; peritoneal neoplasms; ovarian neoplasms - antineoplastic agents - zejula is indicated: , as monotherapy for the maintenance treatment of adult patients with advanced epithelial (figo stages iii and iv) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy., as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy.

New Zealand - English - Medsafe (Medicines Safety Authority)

astrazeneca limited - olaparib 50mg - capsule - 50 mg - active: olaparib 50mg excipient: gellan gum hypromellose lauroyl macrogol-32 glycerides iron oxide black potassium acetate shellac titanium dioxide - lynparza is indicated as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed brca-mutated (germline or somatic) high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) after platinum-based chemotherapy. prior treatment must have included at least 2 courses of platinum-based regimens.

European Union - English - EMA (European Medicines Agency)

astrazeneca ab - olaparib - ovarian neoplasms - antineoplastic agents - ovarian cancerlynparza is indicated as monotherapy for the:maintenance treatment of adult patients with advanced (figo stages iii and iv) brca1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.maintenance treatment of adult patients with platinum sensitive relapsed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy.lynparza in combination with bevacizumab is indicated for the:maintenance treatment of adult patients with advanced (figo stages iii and iv) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (hrd) positive status defined by either a brca1/2 mutation and/or genomic instability (see section 5.1).breast cancerlynparza is indicated as:monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline brca1/2-mutations who have her2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4.2 and 5.1).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 previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments (see section 5.1). patients with hormone receptor (hr)-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy.adenocarcinoma of the pancreaslynparza is indicated as:monotherapy for the maintenance treatment of adult patients with germline brca1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen.prostate cancerlynparza is indicated as:monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mcrpc) and brca1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent.in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mcrpc in whom chemotherapy is not clinically indicated (see section 5.1).

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).