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

baxter healthcare corporation - bendamustine hydrochloride (unii: 981y8sx18m) (bendamustine - unii:9266d9p3pq) - bendamustine hydrochloride injection is indicated for the treatment of adult patients with chronic lymphocytic leukemia. efficacy relative to first line therapies other than chlorambucil has not been established. bendamustine hydrochloride injection is indicated for the treatment of adult patients with indolent b-cell non-hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. bendamustine hydrochloride injection is contraindicated in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine, polyethylene glycol 400, alcohol, or monothioglycerol. [see warnings and precautions (5.4)] risk summary in animal reproduction studies, intraperitoneal administration of bendamustine to pregnant mice and rats during organogenesis at doses 0.6 to 1.8 times the maximum recommended human dose (mrhd) resulted in embryo-fetal and/or infant mortality, structural abnormalities, and alterations to growth (see data ). there are no available data on bendamustine hydrochloride use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. 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 animal data bendamustine hydrochloride was intraperitoneally administered once to mice from 210 mg/m2 (approximately 1.8 times the mrhd) during organogenesis and caused an increase in resorptions, skeletal and visceral malformations (exencephaly, cleft palates, accessory rib, and spinal deformities) and decreased fetal body weights. this dose did not appear to be maternally toxic and lower doses were not evaluated. repeat intraperitoneal administration of bendamustine hydrochloride in mice on gestation days 7 to 11 resulted in an increase in resorptions from 75 mg/m2 (approximately 0.6 times the mrhd) and an increase in abnormalities from 112.5 mg/m2 (approximately 0.9 times the mrhd), similar to those seen after a single intraperitoneal administration. bendamustine hydrochloride was intraperitoneally administered once to rats from 120 mg/m2 (approximately the mrhd) on gestation days 4, 7, 9, 11, or 13 and caused embryo and fetal lethality as indicated by increased resorptions and a decrease in live fetuses. a significant increase in external (effect on tail, head, and herniation of external organs [exomphalos]) and internal (hydronephrosis and hydrocephalus) malformations were seen in dosed rats. risk summary there are no data on the presence of bendamustine hydrochloride or its metabolites in either human or animal milk, the effects on the breastfed child, or the effects on milk production. because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with bendamustine hydrochloride injection, and for 1 week after the last dose. bendamustine hydrochloride injection can cause embryo-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 initiation of treatment with bendamustine hydrochloride injection. contraception females advise female patients of reproductive potential to use effective contraception during treatment with bendamustine hydrochloride injection and for 6 months after the last dose. males based on genotoxicity findings, advise males with female partners of reproductive potential to use effective contraception during treatment with bendamustine hydrochloride injection and for 3 months after the last dose [see nonclinical toxicology (13.1)] . infertility based on findings from clinical studies, bendamustine hydrochloride injection may impair male fertility. impaired spermatogenesis, azoospermia, and total germinal aplasia have been reported in male patients treated with alkylating agents, especially in combination with other drugs. in some instances, spermatogenesis may return in patients in remission, but this may occur only several years after intensive chemotherapy has been discontinued. advise patients of the potential risk to their reproductive capacities. based on findings from animal studies, bendamustine hydrochloride injection may impair male fertility due to an increase in morphologically abnormal spermatozoa. the long-term effects of bendamustine hydrochloride injection on male fertility, including the reversibility of adverse effects, have not been studied [see nonclinical toxicology (13.1)] . safety and effectiveness in pediatric patients have not been established. safety, pharmacokinetics and efficacy were assessed in a single open-label trial (nct01088984) in patients aged 1 to 19 years with relapsed or refractory acute leukemia, including 27 patients with acute lymphocytic leukemia (all) and 16 patients with acute myeloid leukemia (aml). bendamustine hydrochloride was administered as an intravenous infusion over 60 minutes on days 1 and 2 of each 21-day cycle. there was no treatment response (cr+ crp) in any patient. the safety profile in these patients was consistent with that seen in adults, and no new safety signals were identified. the pharmacokinetics of bendamustine in 43 patients, aged 1 to 19 years (median age of 10 years) were within range of values previously observed in adults given the same dose based on body surface area. no overall differences in safety were observed between patients ≥65 years of age and younger patients. efficacy was lower in patients 65 and over with cll receiving bendamustine hydrochloride based upon an overall response rate of 47% for patients 65 and over and 70% for younger patients. progression free survival was also longer in younger patients with cll receiving bendamustine (19 months vs. 12 months). no overall differences in efficacy in patients with non-hodgkin lymphoma were observed between geriatric patients and younger patients. do not use bendamustine hydrochloride injection in patients with creatinine clearance (clcr) < 30 ml/min [see clinical pharmacology (12.3)] . do not use bendamustine hydrochloride injection in patients with ast or alt 2.5-10 × upper limit of normal (uln) and total bilirubin 1.5-3 × uln, or total bilirubin > 3 × uln [see clinical pharmacology (12.3)]

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

bluepoint laboratories - bendamustine hydrochloride (unii: 981y8sx18m) (bendamustine - unii:9266d9p3pq) - bendamustine hydrochloride for injection is indicated for the treatment of patients with chronic lymphocytic leukemia. efficacy relative to first line therapies other than chlorambucil has not been established. bendamustine hydrochloride for injection is indicated for the treatment of patients with indolent b-cell non-hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. bendamustine hydrochloride for injection is contraindicated in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine. [see warnings and precautions ( 5.4)] risk summary in animal reproduction studies, intraperitoneal administration of bendamustine to pregnant mice and rats during organogenesis at doses 0.6 to 1.8 times the maximum recommended human dose (mrhd) resulted in embryo-fetal and/or infant mortality, structural abnormalities, and alterations to growth

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

apotex corp - bendamustine hydrochloride (unii: 981y8sx18m) (bendamustine - unii:9266d9p3pq) - bendamustine hydrochloride injection is indicated for the treatment of patients with indolent b-cell non-hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. bendamustine hydrochloride injection is contraindicated in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine, polyethylene glycol 400, absolute ethanol, sodium hydroxide and monothioglycerol. [see warnings and precautions (5.4)]   risk summary in animal reproduction studies, intraperitoneal administration of bendamustine to pregnant mice and rats during organogenesis at doses 0.6 to 1.8 times the maximum recommended human dose (mrhd) resulted in embryo-fetal and/or infant mortality, structural abnormalities, and alterations to growth (see data). there are no available data on bendamustine hydrochloride use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. 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   animal data bendamustine hydrochloride was intraperitoneally administered once to mice from 210 mg/m2 (approximately 1.8 times the mrhd) during organogenesis and caused an increase in resorptions, skeletal and visceral malformations (exencephaly, cleft palates, accessory rib, and spinal deformities) and decreased fetal body weights. this dose did not appear to be maternally toxic and lower doses were not evaluated. repeat intraperitoneal administration of bendamustine hydrochloride in mice on gestation days 7 to 11 resulted in an increase in resorptions from 75 mg/m2 (approximately 0.6 times the mrhd) and an increase in abnormalities from 112.5 mg/m2 (approximately 0.9 times the mrhd), similar to those seen after a single intraperitoneal administration.   bendamustine hydrochloride was intraperitoneally administered once to rats from 120 mg/m2 (approximately the mrhd) on gestation days 4, 7, 9, 11, or 13 and caused embryo and fetal lethality as indicated by increased resorptions and a decrease in live fetuses. a significant increase in external (effect on tail, head, and herniation of external organs [exomphalos]) and internal (hydronephrosis and hydrocephalus) malformations were seen in dosed rats. risk summary there are no data on the presence of bendamustine hydrochloride or its metabolites in either human or animal milk, the effects on the breastfed child, or the effects on milk production. because of the potential for serious adverse reactions in the breastfed child, advise patients that breastfeeding is not recommended during treatment with bendamustine hydrochloride injection, and for 1 week after the last dose. bendamustine hydrochloride injection can cause embryo-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 initiation of treatment with bendamustine hydrochloride injection.   contraception females advise female patients of reproductive potential to use effective contraception during treatment with bendamustine hydrochloride injection and for 6 months after the last dose.   males based on genotoxicity findings, advise males with female partners of reproductive potential to use effective contraception during treatment with bendamustine hydrochloride injection and for 3 months after the last dose [see nonclinical toxicology (13.1)].   infertility based on findings from clinical studies, bendamustine hydrochloride injection may impair male fertility. impaired spermatogenesis, azoospermia, and total germinal aplasia have been reported in male patients treated with alkylating agents, especially in combination with other drugs. in some instances, spermatogenesis may return in patients in remission, but this may occur only several years after intensive chemotherapy has been discontinued. advise patients of the potential risk to their reproductive capacities. based on findings from animal studies, bendamustine hydrochloride injection may impair male fertility due to an increase in morphologically abnormal spermatozoa. the long-term effects of bendamustine hydrochloride injection on male fertility, including the reversibility of adverse effects, have not been studied [see nonclinical toxicology (13.1)]. safety and effectiveness in pediatric patients have not been established.   safety, pharmacokinetics and efficacy were assessed in a single open-label trial (nct01088984) in patients aged 1 to 19 years with relapsed or refractory acute leukemia, including 27 patients with acute lymphocytic leukemia (all) and 16 patients with acute myeloid leukemia (aml). bendamustine hydrochloride was administered as an intravenous infusion over 60 minutes on days 1 and 2 of each 21-day cycle. there was no treatment response (cr+ crp) in any patient. the safety profile in these patients was consistent with that seen in adults, and no new safety signals were identified. the pharmacokinetics of bendamustine in 43 patients, aged 1 to 19 years (median age of 10 years) were within range of values previously observed in adults given the same dose based on body surface area. no overall differences in safety were observed between patients ≥65 years of age and younger patients. no overall differences in efficacy in patients with non-hodgkin lymphoma were observed between geriatric patients and younger patients.   do not use bendamustine hydrochloride injection in patients with creatinine clearance (clcr) < 30 ml/min. [see clinical pharmacology (12.3)] do not use bendamustine hydrochloride injection in patients with ast or alt 2.5 to 10 × upper limit of normal (uln) and total bilirubin 1.5 to 3 × uln, or total bilirubin > 3 × uln [see clinical pharmacology (12.3)]

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

eugia us llc - bendamustine hydrochloride (unii: 981y8sx18m) (bendamustine - unii:9266d9p3pq) - bendamustine hydrochloride for injection is indicated for the treatment of patients with chronic lymphocytic leukemia. efficacy relative to first line therapies other than chlorambucil has not been established. bendamustine hydrochloride for injection is indicated for the treatment of patients with indolent b-cell non-hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regime n. bendamustine hydrochloride is contraindicated in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine. [see warnings and precautions (5.4)] risk summary in animal reproduction studies, intraperitoneal administration of bendamustine to pregnant mice and rats during organogenesis at doses 0.6 to 1.8 times the maximum recommended human dose (mrhd) resulted in embryo-fetal and/or infant mortality, structural abnormalities, and alterations to growth (see data) . there are no available data on bendamustine hydrochlori

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

meitheal pharmaceuticals inc. - bendamustine hydrochloride (unii: 981y8sx18m) (bendamustine - unii:9266d9p3pq) - bendamustine hydrochloride for injection is indicated for the treatment of patients with chronic lymphocytic leukemia. efficacy relative to first line therapies other than chlorambucil has not been established. bendamustine hydrochloride for injection is indicated for the treatment of patients with indolent b-cell non-hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. bendamustine hydrochloride is contraindicated in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine [see warnings and precautions (5.4)]. risk summary in animal reproduction studies, intraperitoneal administration of bendamustine to pregnant mice and rats during organogenesis at doses 0.6 to 1.8 times the maximum recommended human dose (mrhd) resulted in embryo-fetal and/or infant mortality, structural abnormalities, and alterations to growth (see data) . there are no available data on bendamustine hydrochloride use i

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

apotex corp - bendamustine hydrochloride (unii: 981y8sx18m) (bendamustine - unii:9266d9p3pq) - bendamustine hydrochloride for injection is indicated for the treatment of patients with chronic lymphocytic leukemia. efficacy relative to first line therapies other than chlorambucil has not been established. bendamustine hydrochloride for injection is indicated for the treatment of patients with indolent b-cell non-hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. bendamustine hydrochloride is contraindicated in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine. [see warnings and precautions (5.4)]   risk summary in animal reproduction studies, intraperitoneal administration of bendamustine to pregnant mice and rats during organogenesis at doses 0.6 to 1.8 times the maximum recommended human dose (mrhd) resulted in embryo-fetal and/or infant mortality, structural abnormalities, and alterations to growth (see data ). there are no available data on bendamustine hydrochloride use

Malta - English - Medicines Authority

fresenius kabi italia s.r.l via camagre 41, 37063 isola della scala (vr) , italy - powder for concentrate for solution for infusion - bendamustine hydrochloride 2.5 mg/ml - antineoplastic agents

Malta - English - Medicines Authority

fresenius kabi italia s.r.l via camagre 41, 37063 isola della scala (vr) , italy - powder for concentrate for solution for infusion - bendamustine hydrochloride 2.5 mg/ml - antineoplastic agents

Malta - English - Medicines Authority

accord healthcare ireland ltd euro house, euro business park, little island cork, t45 k857, ireland - powder for concentrate for solution for infusion - bendamustine hydrochloride 2.5 mg/ml - antineoplastic agents

Malta - English - Medicines Authority

accord healthcare ireland ltd euro house, euro business park, little island cork, t45 k857, ireland - powder for concentrate for solution for infusion - bendamustine hydrochloride 2.5 mg/ml - antineoplastic agents