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

clovis oncology, inc. - rucaparib camsylate (unii: 41ax9sj8ko) (rucaparib - unii:8237f3u7eh) - rucaparib 200 mg - 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).

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)

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).

Israel - English - Ministry of Health

neopharm ltd, israel - rucaparib as camsylate - film coated tablets - rucaparib as camsylate 200 mg - rucaparib - 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

Israel - English - Ministry of Health

neopharm ltd, israel - rucaparib as camsylate - film coated tablets - rucaparib as camsylate 250 mg - rucaparib - 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

Israel - English - Ministry of Health

neopharm ltd, israel - rucaparib as camsylate - film coated tablets - rucaparib as camsylate 300 mg - rucaparib - 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

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

clovis oncology uk ltd - rucaparib camsilate - tablet - 200mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

clovis oncology uk ltd - rucaparib camsilate - tablet - 250mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

clovis oncology uk ltd - rucaparib camsilate - tablet - 300mg

Bangladesh - English - DGDA (Directorate General of Drug Administration)

drug international ltd., squib road - rucaparib - tablet - 300 mg