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.

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - niraparib tosilate monohydrate 159.4mg equivalent to niraparib 100mg;   - capsule - 100 mg - active: niraparib tosilate monohydrate 159.4mg equivalent to niraparib 100mg   excipient: black ink sw-9049 brilliant blue fcf erythrosine gelatin lactose monohydrate magnesium stearate tartrazine titanium dioxide white ink sb-007 - 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. the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response 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.

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

glaxosmithkline australia pty ltd - niraparib tosilate monohydrate, quantity: 159.3 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; lactose monohydrate; povidone; crospovidone; silicon dioxide; magnesium stearate; polyvinyl alcohol; titanium dioxide; macrogol 4000; purified talc; ferrosoferric oxide - zejula is indicated:,- 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)

janssen-cilag international n.v. - abiraterone acetate, niraparib tosilate monohydrate - prostatic neoplasms, castration-resistant - antineoplastic agents - treatment of adult patients with prostate cancer.

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

tesaro, inc. - niraparib (unii: hmc2h89n35) (niraparib - unii:hmc2h89n35) - niraparib 100 mg - zejula® is indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. zejula® is indicated for the treatment of adult patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (hrd) positive status defined by either: - a deleterious or suspected deleterious brca mutation, or - genomic instability and who have progressed more than six months after response to the last platinum-based chemotherapy [see clinical studies (14.2)] . select patients for therapy based on an fda-approved companion diagnostic for zejula. 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

Israel - English - Ministry of Health

medison pharma ltd - niraparib as tosylate monohydrate - hard capsule - niraparib as tosylate monohydrate 100 mg - niraparib - zejula is indicated as monotherapy for the maintenance treatment of adult patients with zejula is indicated:• 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.• 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.

Israel - English - Ministry of Health

medison pharma ltd - niraparib as tosylate monohydrate - hard capsule - niraparib as tosylate monohydrate 100 mg - niraparib - zejula is indicated:• 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.• 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.

Kenya - English - Pharmacy and Poisons Board

beacon medicare limited 9/b/2, toyenbee circular road, motijheel, - niraparib tosylate monohydrate - capsule - niraparib 100mg - niraparib

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)] .