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

bluepoint laboratories - pemetrexed disodium (unii: 2pku919ba9) (pemetrexed - unii:04q9aiz7no) - pemetrexed for injection is indicated: - in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer nsclc, with no egfr or alk genomic tumor aberrations. - in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non- squamous, nsclc. - as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous nsclc whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. - as a single agent for the treatment of patients with recurrent, metastatic non-squamous, nsclc after prior chemotherapy. limitations of use:  pemetrexed for injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer [see clinical studies ( 14.1)] . pemetre

Canada - English - Health Canada

eugia pharma inc. - pemetrexed (pemetrexed disodium) - powder for solution - 100mg - pemetrexed (pemetrexed disodium) 100mg

Canada - English - Health Canada

eugia pharma inc. - pemetrexed (pemetrexed disodium) - powder for solution - 500mg - pemetrexed (pemetrexed disodium) 500mg

Canada - English - Health Canada

eugia pharma inc. - pemetrexed (pemetrexed disodium) - powder for solution - 1000mg - pemetrexed (pemetrexed disodium) 1000mg

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

qilu pharmaceutical co., ltd. - pemetrexed disodium hemipentahydrate (unii: f4gsh45r4c) (pemetrexed - unii:04q9aiz7no) - pemetrexed for injection is indicated: - in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous nsclc, with no egfr or alk genomic tumor aberrations. - in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (nsclc). - as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous nsclc whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. - as a single agent for the treatment of patients with recurrent, metastatic non-squamous, nsclc after prior chemotherapy. limitations of use: pemetrexed for injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer [see clinical studies (14.1)]. pemetrexed for injection is indicated, in combination with cisplatin, for the initial treatment of patients with malignant pleural mesot

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

athenex pharmaceutical division, llc. - pemetrexed disodium hemipentahydrate (unii: f4gsh45r4c) (pemetrexed - unii:04q9aiz7no) - pemetrexed for injection is indicated: - in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer (nsclc), with no egfr or alk genomic tumor aberrations. in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer (nsclc), with no egfr or alk genomic tumor aberrations. - in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous nsclc. - as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous nsclc whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. - as a single agent for the treatment of patients with recurrent, metastatic non-squamous, nsclc after prior chemotherapy. limitations of use:

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

ingenus pharmaceuticals, llc - pemetrexed disodium hemipentahydrate (unii: f4gsh45r4c) (pemetrexed - unii:04q9aiz7no) - pemetrexed for injection is indicated: - in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer (nsclc), with no egfr or alk genomic tumor aberrations. - in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous nsclc. - as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous nsclc whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. - as a single agent for the treatment of patients with recurrent, metastatic non-squamous, nsclc after prior chemotherapy. limitations of use: pemetrexed for injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer [see clinical studies (14.1)]. pemetrexed for injection is indicated, in combination with cisplatin, for the initial treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery. pemetrexed for injection is contraindicated in patients with a history of severe hypersensitivity reaction to pemetrexed [see adverse reactions (6.1)]. risk summary based on findings from animal studies and its mechanism of action, pemetrexed for injection can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on pemetrexed for injection use in pregnant women. in animal reproduction studies, intravenous administration of pemetrexed to pregnant mice during the period of organogenesis was teratogenic, resulting in developmental delays and malformations at doses lower than the recommended human dose of 500 mg/m2 [see data] . advise pregnant women of the potential risk to a fetus [see use in special populations (8.3)] . 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 pemetrexed was teratogenic in mice. daily dosing of pemetrexed by intravenous injection to pregnant mice during the period of organogenesis increased the incidence of fetal malformations (cleft palate; protruding tongue; enlarged or misshaped kidney; and fused lumbar vertebra) at doses (based on bsa) 0.03 times the human dose of 500 mg/m2 . at doses, based on bsa, greater than or equal to 0.0012 times the 500 mg/m2 human dose, pemetrexed administration resulted in dose-dependent increases in developmental delays (incomplete ossification of talus and skull bone; and decreased fetal weight). risk summary there is no information regarding the presence of pemetrexed or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. because of the potential for serious adverse reactions in breastfed infants from pemetrexed for injection, advise women not to breastfeed during treatment with pemetrexed for injection and for one week after the last dose. based on animal data pemetrexed for injection can cause malformations and developmental delays when administered to a pregnant woman [see use in specific populations (8.1)] . pregnancy testing verify pregnancy status of females of reproductive potential prior to initiating pemetrexed injection [see use in specific populations (8.1)] . contraception females because of the potential for genotoxicity, advise females of reproductive potential to use effective contraception during treatment with pemetrexed for injection and for 6 months after the last dose. males because of the potential for genotoxicity, advise males with female partners of reproductive potential to use effective contraception during treatment with pemetrexed for injection and for 3 months after the last dose [see nonclinical toxicology (13.1)] . infertilit y males pemetrexed for injection may impair fertility in males of reproductive potential. it is not known whether these effects on fertility are reversible [see nonclinical toxicology (13.1)] . the safety and effectiveness of pemetrexed for injection in pediatric patients have not been established. the safety and pharmacokinetics of pemetrexed for injection were evaluated in two clinical studies conducted in pediatric patients with recurrent solid tumors. (nct00070473 n=32 and nct00520936 n=72). patients in both studies received concomitant vitamin b12 and folic acid supplementation and dexamethasone. no tumor responses were observed. adverse reactions observed in pediatric patients were similar to those observed in adults. single-dose pharmacokinetics of pemetrexed for injection were evaluated in 22 patients age 4 to 18 years enrolled in nct00070473 were within range of values in adults. of the 3,946 patients enrolled in clinical studies of pemetrexed for injection, 34% were 65 and over and 4% were 75 and over. no overall differences in effectiveness were observed between these patients and younger patients. the incidences of grade 3-4 anemia, fatigue, thrombocytopenia, hypertension, and neutropenia were higher in patients 65 years of age and older as compared to younger patients: in at least one of five randomized clinical trials. [see adverse reactions (6.1) and clinical studies (14.1, 14.2)]. pemetrexed for injection is primarily excreted by the kidneys. decreased renal function results in reduced clearance and greater exposure (auc) to pemetrexed for injection compared with patients with normal renal function [warnings and precautions (5.2, 5.6) and clinical pharmacology (12.3)] . no dose is recommended for patients with creatinine clearance less than 45 ml/min [see dosage and administration (2.3)].

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

zydus pharmaceuticals usa inc. - pemetrexed disodium (unii: 2pku919ba9) (pemetrexed - unii:04q9aiz7no) - pemetrexed for injection, usp is indicated: - in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous nsclc, with no egfr or alk genomic tumor aberrations. - in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (nsclc). - as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous nsclc whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. - as a single agent for the treatment of patients with recurrent, metastatic non-squamous, nsclc after prior chemotherapy. limitations of use : pemetrexed for injection, usp is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer [see clinical studies (14.1)]. pemetrexed for injection, usp is indicated, in combination with cisplatin, for

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

fresenius kabi usa, llc - pemetrexed disodium (unii: 2pku919ba9) (pemetrexed - unii:04q9aiz7no) - pemetrexed for injection is indicated: - in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer (nsclc), with no egfr or alk genomic tumor aberrations. - in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous nsclc. - as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous nsclc whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. - as a single agent for the treatment of patients with recurrent, metastatic non-squamous, nsclc after prior chemotherapy. limitations of use: pemetrexed for injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer [see clinical studies (14.1)]. pemetrexed for injection is indicated, in combination with cisplatin, for the initial treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery. pemetrexed for injection is contraindicated in patients with a history of severe hypersensitivity reaction to pemetrexed [see adverse reactions (6.1)]. risk summary based on findings from animal studies and its mechanism of action, pemetrexed for injection can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on pemetrexed for injection use in pregnant women. in animal reproduction studies, intravenous administration of pemetrexed to pregnant mice during the period of organogenesis was teratogenic, resulting in developmental delays and malformations at doses lower than the recommended human dose of 500 mg/m2 [see data] . advise pregnant women of the potential risk to a fetus [see use in special populations (8.3)] . 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 pemetrexed was teratogenic in mice. daily dosing of pemetrexed by intravenous injection to pregnant mice during the period of organogenesis increased the incidence of fetal malformations (cleft palate; protruding tongue; enlarged or misshaped kidney; and fused lumbar vertebra) at doses (based on bsa) 0.03 times the human dose of 500 mg/m2 . at doses, based on bsa, greater than or equal to 0.0012 times the 500 mg/m2 human dose, pemetrexed administration resulted in dose-dependent increases in developmental delays (incomplete ossification of talus and skull bone; and decreased fetal weight). risk summary there is no information regarding the presence of pemetrexed or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. because of the potential for serious adverse reactions in breastfed infants from pemetrexed for injection, advise women not to breastfeed during treatment with pemetrexed for injection and for one week after the last dose. based on animal data pemetrexed for injection can cause malformations and developmental delays when administered to a pregnant woman [see use in specific populations (8.1)]. pregnancy testing verify pregnancy status of females of reproductive potential prior to initiating pemetrexed injection [see use in specific populations (8.1)] . contraception females because of the potential for genotoxicity, advise females of reproductive potential to use effective contraception during treatment with pemetrexed for injection and for 6 months after the last dose. males because of the potential for genotoxicity, advise males with female partners of reproductive potential to use effective contraception during treatment with pemetrexed for injection and for 3 months after the last dose [see nonclinical toxicology (13.1)] . infertility males pemetrexed for injection may impair fertility in males of reproductive potential. it is not known whether these effects on fertility are reversible [see nonclinical toxicology (13.1)] . the safety and effectiveness of pemetrexed for injection in pediatric patients have not been established. the safety and pharmacokinetics of pemetrexed for injection were evaluated in two clinical studies conducted in pediatric patients with recurrent solid tumors (nct00070473 n=32 and nct00520936 n=72). patients in both studies received concomitant vitamin b12 and folic acid supplementation and dexamethasone. no tumor responses were observed. adverse reactions observed in pediatric patients were similar to those observed in adults. single-dose pharmacokinetics of pemetrexed for injection were evaluated in 22 patients age 4 to 18 years enrolled in nct00070473 were within range of values in adults. of the 3,946 patients enrolled in clinical studies of pemetrexed for injection, 34% were 65 and over and 4% were 75 and over. no overall differences in effectiveness were observed between these patients and younger patients. the incidences of grade 3-4 anemia, fatigue, thrombocytopenia, hypertension, and neutropenia were higher in patients 65 years of age and older as compared to younger patients: in at least one of five randomized clinical trials. [see adverse reactions (6.1) and clinical studies (14.1, 14.2)]. pemetrexed for injection is primarily excreted by the kidneys. decreased renal function results in reduced clearance and greater exposure (auc) to pemetrexed for injection compared with patients with normal renal function [see warnings and precautions (5.2, 5.6) and clinical pharmacology (12.3)] . no dose is recommended for patients with creatinine clearance less than 45 ml/min [see dosage and administration (2.3)].

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

apotex corp - pemetrexed disodium (unii: 2pku919ba9) (pemetrexed - unii:04q9aiz7no) - pemetrexed for injection is indicated: - in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer (nsclc), with no egfr or alk genomic tumor aberrations. - in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic non-squamous nsclc. - as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous nsclc whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. - as a single agent for the treatment of patients with recurrent, metastatic non-squamous, nsclc after prior chemotherapy. limitations of use: pemetrexed for injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer [see clinical studies (14.1) ] . pemetrexed for injection is indicated, in combination with cisplatin, for the initial treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery. pemetrexed for injection is contraindicated in patients with a history of severe hypersensitivity reaction to pemetrexed [see adverse reactions (6.1)] . risk summary based on findings from animal studies and its mechanism of action, pemetrexed for injection can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on pemetrexed for injection use in pregnant women. in animal reproduction studies, intravenous administration of pemetrexed for injection to pregnant mice during the period of organogenesis was teratogenic, resulting in developmental delays and malformations at doses lower than the recommended human dose of 500 mg/m2 [see data ]. advise pregnant women of the potential risk to a fetus[see use in special populations (8.3)] .   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 pemetrexed for injection was teratogenic in mice. daily dosing of pemetrexed for injection by intravenous injection to pregnant mice during the period of organogenesis increased the incidence of fetal malformations (cleft palate; protruding tongue; enlarged or misshaped kidney; and fused lumbar vertebra) at doses (based on bsa) 0.03 times the human dose of 500 mg/m2. at doses, based on bsa, greater than or equal to 0.0012 times the 500 mg/m2 human dose, pemetrexed for injection administration resulted in dose-dependent increases in developmental delays (incomplete ossification of talus and skull bone; and decreased fetal weight). risk summary there is no information regarding the presence of pemetrexed for injection or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. because of the potential for serious adverse reactions in breastfed infants from pemetrexed for injection, advise women not to breastfeed during treatment with pemetrexed for injection and for one week after the last dose. based in animal data pemetrexed can cause malformations and developmental delays harm when administered to a pregnant woman [see use in specific populations (8.1)] . pregnancy testing verify pregnancy status of females of reproductive potential prior to initiating pemetrexed injection [see use in specific populations (8.1)]. contraception females because of the potential for genotoxicity, advise females of reproductive potential to use effective contraception during treatment with pemetrexed  and for 6 months after the last dose. males because of the potential for genotoxicity, advise males with female partners of reproductive potential to use effective contraception during treatment with pemetrexed and for 3 months after the last dose [see nonclinical toxicology (13.1)]. infertility males pemetrexed may impair fertility in males of reproductive potential. it is not known whether these effects on fertility are reversible [see nonclinical toxicology (13.1)]. the safety and effectiveness of pemetrexed in pediatric patients have not been established. the safety and pharmacokinetics of pemetrexed were evaluated in two clinical studies conducted in pediatric patients with recurrent solid tumors (nct00070473 n=32 and nct00520936 n=72). patients in both studies received concomitant vitamin b12 and folic acid supplementation and dexamethasone. no tumor responses were observed. adverse reactions observed in pediatric patients were similar to those observed in adults. single-dose pharmacokinetics of pemetrexed were evaluated in 22 patients age 4 to 18 years enrolled in nct00070473 were within range of values in adults. of the 3,946 patients enrolled in clinical studies of pemetrexed for injection, 34% were 65 and over and 4% were 75 and over. no overall differences in effectiveness were observed between these patients and younger patients. the incidences of grade 3-4 anemia, fatigue, thrombocytopenia, hypertension, and neutropenia were higher in patients 65 years of age and older as compared to younger patients: in at least one of five randomized clinical trials. [see adverse reactions (6.1) and clinical studies (14.1, 14.2)] .  pemetrexed for injection is primarily excreted by the kidneys. decreased renal function results in reduced clearance and greater exposure (auc) to pemetrexed for injection compared with patients with normal renal function [warnings and precautions (5.2, 5.6) and clinical pharmacology (12.3)] . no dose is recommended for patients with creatinine clearance less than 45 ml/min [see dosage and administration (2.3)] .