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

bluepoint laboratories - 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 treatm

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

waverley pharma inc - pemetrexed disodium heptahydrate (unii: 9t47e4om16) (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 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 last dose. contraception females pemetrexed for injection can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . because of the potential for genotoxicity, advise females of reproductive potential to use effective contraception during treatment with pemetrexed for injection for at least 6 months after the final dose of pemetrexed for injection. 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 final 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. pemetrexed for injection was administered at doses ranging from 400 to 2480 mg/m2 intravenously over 10 minutes on day 1 of a 21-day cycle to 32 pediatric patients with recurrent solid tumors in a dose-finding study. the maximum tolerated dose (mtd) was determined to be 1910 mg/m2 (60 mg/kg for patients <12 months old). pemetrexed for injection was administered at the mtd every 21 days in an activity-estimating study enrolling 72 patients with relapsed or refractory osteosarcoma, ewing sarcoma/peripheral primitive neural ectodermal tumor (pnet), rhabdomyosarcoma, neuroblastoma, ependymoma, medulloblastoma/supratentorial pnet, or non-brainstem high grade glioma. 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 administered at doses ranging from 400 to 2480 mg/m2 were evaluated in 22 patients (13 males and 9 females) age 4 to 18 years (average age 12 years). pemetrexed exposure (auc and cmax ) appeared to increase proportionally with dose. average clearance (2.30 l/h/m2 ) and half-life (2.3 hours) were similar in pediatric patients compared to 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)

meitheal pharmaceuticals inc. - 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 me

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

meitheal pharmaceuticals inc. - pemetrexed disodium heptahydrate (unii: 9t47e4om16) (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 mes

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

meitheal pharmaceuticals inc. - 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 me

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

shilpa medicare limited - pemetrexed disodium hemipentahydrate (unii: f4gsh45r4c) (pemetrexed - unii:04q9aiz7no) - pemetrexed 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 injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer [see clinical studies (14.1)]. pemetrexed injection is indicated, in combination with cisplatin, for the initial treatment of patients with malignant pleural mesothelioma whose d

Canada - English - Health Canada

taro pharmaceuticals inc - pemetrexed (pemetrexed disodium) - powder for solution - 100mg - pemetrexed (pemetrexed disodium) 100mg - antineoplastic agents

Canada - English - Health Canada

taro pharmaceuticals inc - pemetrexed (pemetrexed disodium) - powder for solution - 500mg - pemetrexed (pemetrexed disodium) 500mg - antineoplastic agents

Canada - English - Health Canada

taro pharmaceuticals inc - pemetrexed (pemetrexed disodium) - powder for solution - 1000mg - pemetrexed (pemetrexed disodium) 1000mg - antineoplastic agents

Canada - English - Health Canada

accord healthcare inc - pemetrexed (pemetrexed disodium hemipentahydrate) - powder for solution - 100mg - pemetrexed (pemetrexed disodium hemipentahydrate) 100mg - antineoplastic agents