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

amring pharmaceuticals inc. - arsenic trioxide (unii: s7v92p67ho) (arsenic cation (3+) - unii:c96613f5av) - arsenic trioxide injection is indicated for induction of remission and consolidation in patients with apl who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose apl is characterized by the presence of the t(15;17) translocation or pml/rar-alpha gene expression. arsenic trioxide is contraindicated in patients with hypersensitivity to arsenic. risk summary based on the mechanism of action [see clinical pharmacology (12.1)] and findings in animal studies, arsenic trioxide can cause fetal harm when administered to a pregnant woman. arsenic trioxide was embryolethal and teratogenic in rats when administered on gestation day 9 at a dose approximately 10 times the recommended human daily dose on a mg/m2 basis (see data). a related trivalent arsenic, sodium arsenite, produced teratogenicity when administered during gestation in mice at a dose approximately 5 times the projected human dose on a mg/m2 basis and in hamsters at an intravenous dose approximately equivalent to

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

zydus pharmaceuticals usa inc. - arsenic trioxide (unii: s7v92p67ho) (arsenic cation (3+) - unii:c96613f5av) - arsenic trioxide injection is indicated for induction of remission and consolidation in patients with acute promyelocytic leukemia (apl) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose apl is characterized by the presence of the t(15;17) translocation or pml/rar-alpha gene expression. arsenic trioxide is contraindicated in patients with hypersensitivity to arsenic. risk summary based on the mechanism of action [see clinical pharmacology (12.1)] and findings in animal studies, arsenic trioxide can cause fetal harm when administered to a pregnant woman. arsenic trioxide was embryolethal and teratogenic in rats when administered on gestation day 9 at a dose approximately 10 times the recommended human daily dose on a mg/m2 basis (see data) . a related trivalent arsenic, sodium arsenite, produced teratogenicity when administered during gestation in mice at a dose approximately 5 times the projected human dose on a mg/m2 basis and in hamsters at an intravenous do

Canada - English - Health Canada

sterimax inc - arsenic trioxide - solution - 1mg - arsenic trioxide 1mg - antineoplastic agents

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

athenex pharmaceutical division, llc - arsenic trioxide (unii: s7v92p67ho) (arsenic cation (3+) - unii:c96613f5av) - arsenic trioxide injection is indicated for induction of remission and consolidation in patients with apl who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose apl is characterized by the presence of the t(15;17) translocation or pml/rar-alpha gene expression. arsenic trioxide injection is contraindicated in patients with hypersensitivity to arsenic. risk summary based on the mechanism of action [see clinical pharmacology (12.1)] and findings in animal studies, arsenic trioxide injection can cause fetal harm when administered to a pregnant woman. arsenic trioxide was embryolethal and teratogenic in rats when administered on gestation day 9 at a dose approximately 10 times the recommended human daily dose on a mg/m² basis (see data) . a related trivalent arsenic, sodium arsenite, produced teratogenicity when administered during gestation in mice at a dose approximately 5 times the projected human dose on a mg/m² basis and in hamsters at an intravenous dose approximately equivalent to the projected human daily dose on a mg/m² basis. there are no studies with the use of arsenic trioxide injection in pregnant women, and limited published data on arsenic trioxide use during pregnancy are insufficient to inform a drug-associated risk of major birth defects and miscarriage. advise pregnant women of the potential risk to a fetus. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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 human data one patient was reported to deliver a live infant with no reported congenital anomalies after receiving arsenic trioxide during the first five months of pregnancy. a second patient became pregnant three months after discontinuing arsenic trioxide and was reported to have a normal pregnancy outcome. a third patient was a pregnant healthcare provider who experienced dermal contact with liquid arsenic trioxide and had a normal pregnancy outcome after treatment and monitoring. a fourth patient who became pregnant while receiving arsenic trioxide had a miscarriage. animal data studies in pregnant mice, rats, hamsters, and primates have shown that inorganic arsenicals cross the placental barrier when given orally or by injection. an increase in resorptions, neural-tube defects, anophthalmia and microphthalmia were observed in rats administered 10 mg/kg of arsenic trioxide on gestation day 9 (approximately 10 times the recommended human daily dose on a mg/m² basis). similar findings occurred in mice administered a 10 mg/kg dose of a related trivalent arsenic, sodium arsenite (approximately 5 times the projected human dose on a mg/m² basis), on gestation days 6, 7, 8, or 9. intravenous injection of 2 mg/kg sodium arsenite (approximately equivalent to the projected human daily dose on a mg/m² basis) on gestation day 7 (the lowest dose tested) resulted in neural-tube defects in hamsters. risk summary arsenic trioxide is excreted in human milk. there are no data on the effects of arsenic trioxide on the breastfed child or on milk production. because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with arsenic trioxide injection and for 2 weeks after the final dose. arsenic trioxide injection can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)]. pregnancy testing conduct pregnancy testing in females of reproductive potential prior to initiation of arsenic trioxide injection. contraception females advise females of reproductive potential to use effective contraception during treatment with arsenic trioxide injection and for 6 months after the final dose. males advise males with female partners of reproductive potential to use effective contraception during treatment with arsenic trioxide injection and for 3 months after the final dose. infertility males based on testicular toxicities including decreased testicular weight and impaired spermatogenesis observed in animal studies, arsenic trioxide injection may impair fertility in males of reproductive potential [see nonclinical toxicology (13.1)] . the safety and efficacy of arsenic trioxide injection as a single agent for treatment of pediatric patients with relapsed or refractory apl is supported by the pivotal phase 2 study in 40 patients with relapsed or refractory apl. five patients below the age of 18 years (age range: 5 to 16 years) were treated with arsenic trioxide injection at the recommended dose of 0.15 mg/kg/day. a literature review included an additional 17 patients treated with arsenic trioxide for relapsed or refractory apl, with ages ranging from 4 to 21 years. no differences in efficacy and safety were observed by age. use of arsenic trioxide injection as monotherapy in patients with relapsed or refractory apl is supported by the open-label, single-arm trial that included 6 patients aged 65 and older (range: 65 to 73 years). a literature review included an additional 4 patients aged 69 to 72 years who were treated with arsenic trioxide for relapsed or refractory apl. no overall differences in safety or effectiveness were observed between these patients and younger patients. exposure of arsenic trioxide may be higher in patients with severe renal impairment [see clinical pharmacology (12.3)] . monitor patients with severe renal impairment (creatinine clearance [clcr] less than 30 ml/min) frequently for toxicity; a dose reduction may be warranted. the use of arsenic trioxide injection in patients on dialysis has not been studied. since limited data are available across all hepatic impairment groups, caution is advised in the use of arsenic trioxide injection in patients with hepatic impairment [see clinical pharmacology (12.3)] . monitor patients with severe hepatic impairment (child-pugh class c) frequently for toxicity.

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

amneal pharmaceuticals llc - arsenic trioxide (unii: s7v92p67ho) (arsenic cation (3+) - unii:c96613f5av) - arsenic trioxide injection is indicated for induction of remission and consolidation in patients with apl who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose apl is characterized by the presence of the t(15;17) translocation or pml/rar-alpha gene expression. arsenic trioxide injection is contraindicated in patients with hypersensitivity to arsenic. risk summary based on the mechanism of action [see clinical pharmacology (12.1)] and findings in animal studies, arsenic trioxide can cause fetal harm when administered to a pregnant woman. arsenic trioxide was embryolethal and teratogenic in rats when administered on gestation day 9 at a dose approximately 10 times the recommended human daily dose on a mg/m² basis (see data ). a related trivalent arsenic, sodium arsenite, produced teratogenicity when administered during gestation in mice at a dose approximately 5 times the projected human dose on a mg/m² basis and in hamsters at an intravenous dose approximately equivalent to the projected human daily dose on a mg/m² basis. there are no studies with the use of arsenic trioxide in pregnant women, and limited published data on arsenic trioxide use during pregnancy are insufficient to inform a drug-associated risk of major birth defects and miscarriage. advise pregnant women of the potential risk to a fetus. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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 human data one patient was reported to deliver a live infant with no reported congenital anomalies after receiving arsenic trioxide during the first five months of pregnancy. a second patient became pregnant three months after discontinuing arsenic trioxide and was reported to have a normal pregnancy outcome. a third patient was a pregnant healthcare provider who experienced dermal contact with liquid arsenic trioxide and had a normal pregnancy outcome after treatment and monitoring. a fourth patient who became pregnant while receiving arsenic trioxide had a miscarriage. animal data studies in pregnant mice, rats, hamsters, and primates have shown that inorganic arsenicals cross the placental barrier when given orally or by injection. an increase in resorptions, neural-tube defects, anophthalmia and microphthalmia were observed in rats administered 10 mg/kg of arsenic trioxide on gestation day 9 (approximately 10 times the recommended human daily dose on a mg/m² basis). similar findings occurred in mice administered a 10 mg/kg dose of a related trivalent arsenic, sodium arsenite (approximately 5 times the projected human dose on a mg/m² basis), on gestation days 6, 7, 8, or 9. intravenous injection of 2 mg/kg sodium arsenite (approximately equivalent to the projected human daily dose on a mg/m² basis) on gestation day 7 (the lowest dose tested) resulted in neural-tube defects in hamsters.  risk summary arsenic trioxide is excreted in human milk. there are no data on the effects of arsenic trioxide on the breastfed child or on milk production. because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with arsenic trioxide and for 2 weeks after the final dose. arsenic trioxide can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . pregnancy testing conduct pregnancy testing in females of reproductive potential prior to initiation of arsenic trioxide. contraception females advise females of reproductive potential to use effective contraception during treatment with arsenic trioxide and for 6 months after the final dose. males advise males with female partners of reproductive potential to use effective contraception during treatment with arsenic trioxide and for 3 months after the final dose. infertility males based on testicular toxicities including decreased testicular weight and impaired spermatogenesis observed in animal studies, arsenic trioxide may impair fertility in males of reproductive potential [see nonclinical toxicology (13.1)] . the safety and efficacy of arsenic trioxide as a single agent for treatment of pediatric patients with relapsed or refractory apl is supported by the pivotal phase 2 study in 40 patients with relapsed or refractory apl. five patients below the age of 18 years (age range: 5 to 16 years) were treated with arsenic trioxide at the recommended dose of 0.15 mg/kg/day. a literature review included an additional 17 patients treated with arsenic trioxide for relapsed or refractory apl, with ages ranging from 4 to 21 years. no differences in efficacy and safety were observed by age.  use of arsenic trioxide as monotherapy in patients with relapsed or refractory apl is supported by the open-label, single-arm trial that included 6 patients aged 65 and older (range: 65 to 73 years). a literature review included an additional 4 patients aged 69 to 72 years who were treated with arsenic trioxide for relapsed or refractory apl. no overall differences in safety or effectiveness were observed between these patients and younger patients. exposure of arsenic trioxide may be higher in patients with severe renal impairment [see clinical pharmacology (12.3)] . monitor patients with severe renal impairment (creatinine clearance [clcr] less than 30 ml/min) frequently for toxicity; a dose reduction may be warranted. the use of arsenic trioxide in patients on dialysis has not been studied.  since limited data are available across all hepatic impairment groups, caution is advised in the use of arsenic trioxide in patients with hepatic impairment [see clinical pharmacology (12.3)] . monitor patients with severe hepatic impairment (child-pugh class c) frequently for toxicity.

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

ingenus pharmaceuticals, llc - arsenic trioxide (unii: s7v92p67ho) (arsenic cation (3+) - unii:c96613f5av) - arsenic trioxide injection is indicated for induction of remission and consolidation in patients with apl who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose apl is characterized by the presence of the t(15;17) translocation or pml/rar-alpha gene expression. arsenic trioxide injection is contraindicated in patients with hypersensitivity to arsenic.   risk summary based on the mechanism of action [see clinical pharmacology (12.1)] and findings in animal studies, arsenic trioxide injection can cause fetal harm when administered to a pregnant woman. arsenic trioxide was embryolethal and teratogenic in rats when administered on gestation day 9 at a dose approximately 10 times the recommended human daily dose on a mg/m2 basis (see data) . a related trivalent arsenic, sodium arsenite, produced teratogenicity when administered during gestation in mice at a dose approximately 5 times the projected human dose on a mg/m2 basis and in hamsters at an intravenous dose approx

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

gland pharma limited - arsenic trioxide (unii: s7v92p67ho) (arsenic cation (3+) - unii:c96613f5av) - arsenic trioxide injection is indicated for induction of remission and consolidation in patients with apl who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose apl is characterized by the presence of the t(15;17) translocation or pml/rar-alpha gene expression. arsenic trioxide is contraindicated in patients with hypersensitivity to arsenic. risk summary based on the mechanism of action [see clinical pharmacology (12.1)]  and findings in animal studies, arsenic trioxide can cause fetal harm when administered to a pregnant woman. arsenic trioxide was embryolethal and teratogenic in rats when administered on gestation day 9 at a dose approximately 10 times the recommended human daily dose on a mg/m² basis (see data ). a related trivalent arsenic, sodium arsenite, produced teratogenicity when administered during gestation in mice at a dose approximately 5 times the projected human dose on a mg/m² basis and in hamsters at an intravenous dose approximately equivalent to th

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

auromedics pharma llc - arsenic trioxide (unii: s7v92p67ho) (arsenic cation (3+) - unii:c96613f5av) - arsenic trioxide injection is indicated for induction of remission and consolidation in patients with apl who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose apl is characterized by the presence of the t(15;17) translocation or pml/rar-alpha gene expression. arsenic trioxide is contraindicated in patients with hypersensitivity to arsenic. risk summary based on the mechanism of action [see clinical pharmacology (12.1)] and findings in animal studies, arsenic trioxide can cause fetal harm when administered to a pregnant woman. arsenic trioxide was embryolethal and teratogenic in rats when administered on gestation day 9 at a dose approximately 10 times the recommended human daily dose on a mg/m² basis (see data ). a related trivalent arsenic, sodium arsenite, produced teratogenicity when administered during gestation in mice at a dose approximately 5 times the projected human dose on a mg/m² basis and in hamsters at an intravenous dose approximately equivalen

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

sandoz inc - arsenic trioxide (unii: s7v92p67ho) (arsenic cation (3+) - unii:c96613f5av) - arsenic trioxide injection is indicated for induction of remission and consolidation in patients with acute promyelocytic leukemia (apl) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose apl is characterized by the presence of the t(15;17) translocation or pml/rar-alpha gene expression. arsenic trioxide is contraindicated in patients with hypersensitivity to arsenic. risk summary based on the mechanism of action [see clinical pharmacology (12.1)] and findings in animal studies, arsenic trioxide can cause fetal harm when administered to a pregnant woman. arsenic trioxide was embryolethal and teratogenic in rats when administered on gestation day 9 at a dose approximately 10 times the recommended human daily dose on a mg/m² basis (see data) . a related trivalent arsenic, sodium arsenite, produced teratogenicity when administered during gestation in mice at a dose approximately 5 times the projected human dose on a mg/m² basis and in hamsters at an intravenous dose

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

zydus pharmaceuticals usa inc. - arsenic trioxide (unii: s7v92p67ho) (arsenic cation (3+) - unii:c96613f5av) - arsenic trioxide injection is indicated for induction of remission and consolidation in patients with acute promyelocytic leukemia (apl) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose apl is characterized by the presence of the t(15;17) translocation or pml/rar-alpha gene expression. arsenic trioxide is contraindicated in patients with hypersensitivity to arsenic. risk summary based on the mechanism of action [see clinical pharmacology (12.1)] and findings in animal studies, arsenic trioxide can cause fetal harm when administered to a pregnant woman. arsenic trioxide was embryolethal and teratogenic in rats when administered on gestation day 9 at a dose approximately 10 times the recommended human daily dose on a mg/m2 basis (see data) . a related trivalent arsenic, sodium arsenite, produced teratogenicity when administered during gestation in mice at a dose approximately 5 times the projected human dose on a mg/m2 basis and in hamsters at an intravenous do