Estados Unidos - inglês - NLM (National Library of Medicine)

eisai inc. - lenvatinib (unii: ee083865g2) (lenvatinib - unii:ee083865g2) - lenvatinib 10 mg - lenvima is indicated for the treatment of adult patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (dtc).  lenvima, in combination with pembrolizumab, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (rcc). lenvima, in combination with everolimus, is indicated for the treatment of adult patients with advanced rcc following one prior anti-angiogenic therapy. lenvima is indicated for the first-line treatment of patients with unresectable hepatocellular carcinoma (hcc). lenvima, in combination with pembrolizumab, is indicated for the treatment of patients with advanced endometrial carcinoma (ec) that is mismatch repair proficient (pmmr), as determined by an fda-approved test, or not microsatellite instability-high (msi-h), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation [see dosage and administration ( 2.1 )] . none. risk summary based on findings from animal studies and its mechanism of action, lenvima can cause fetal harm when administered to a pregnant woman [see clinical pharmacology ( 12.1 )] . in animal reproduction studies, oral administration of lenvatinib during organogenesis at doses below the recommended human doses resulted in embryotoxicity, fetotoxicity, and teratogenicity in rats and rabbits ( see data ) . there are no available human data informing the drug-associated risk. advise pregnant women of the potential risk to a fetus. 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 an embryofetal development study, daily oral administration of lenvatinib mesylate at doses ≥0.3 mg/kg [approximately 0.14 times the recommended clinical dose of 24 mg based on body surface area (bsa)] to pregnant rats during organogenesis resulted in dose-related decreases in mean fetal body weight, delayed fetal ossifications, and dose-related increases in fetal external (parietal edema and tail abnormalities), visceral, and skeletal anomalies. greater than 80% post-implantation loss was observed at 1.0 mg/kg/day (approximately 0.5 times the recommended clinical dose of 24 mg based on bsa). daily oral administration of lenvatinib mesylate to pregnant rabbits during organogenesis resulted in fetal external (short tail), visceral (retroesophageal subclavian artery), and skeletal anomalies at doses greater than or equal to 0.03 mg/kg (approximately 0.03 times the recommended clinical dose of 24 mg based on bsa). at the 0.03 mg/kg dose, increased post-implantation loss, including 1 fetal death, was also observed. lenvatinib was abortifacient in rabbits, resulting in late abortions in approximately one-third of the rabbits treated at a dose level of 0.5 mg/kg/day (approximately 0.5 times the recommended clinical dose of 24 mg based on bsa). risk summary it is not known whether lenvima is present in human milk; however, lenvatinib and its metabolites are excreted in rat milk at concentrations higher than those in maternal plasma  ( see data ) . because of the potential for serious adverse reactions in breastfed children, advise women to discontinue breastfeeding during treatment with lenvima and for 1 week after the last dose. data animal data following administration of radiolabeled lenvatinib to lactating sprague dawley rats, lenvatinib-related radioactivity was approximately 2 times higher [based on area under the curve (auc)] in milk compared to maternal plasma. based on animal data and its mechanism of action, lenvima can cause fetal harm when administered to a pregnant woman [see use in specific populations ( 8.1 )] . pregnancy testing verify the pregnancy status of females of reproductive potential prior to initiating lenvima [see use in specific populations ( 8.1 )]. contraception females advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment with lenvima and for 30 days after the last dose. infertility lenvima may impair fertility in males and females of reproductive potential [ see nonclinical toxicology ( 13.1 )]. the safety and effectiveness of lenvima in pediatric patients have not been established. the safety and efficacy of lenvima alone and in combination were investigated but not established in four open label studies (nct02432274, nct04154189, nct04447755, nct03245151) in 232 patients aged 2 to <17 years with relapsed or refractory solid tumors, including osteosarcoma, ewing sarcoma, rhabdomyosarcoma, and high-grade glioma. hypothyroidism and pneumothorax were observed at a higher rate in pediatric patients compared to that of adult patients. the pharmacokinetics (pk) of lenvatinib in pediatric patients were within range of values previously observed in adults at the approved recommended dose of 24 mg. juvenile animal data daily oral administration of lenvatinib mesylate to juvenile rats for 8 weeks starting on postnatal day 21 (approximately equal to a human pediatric age of 2 years) resulted in growth retardation (decreased body weight gain, decreased food consumption, and decreases in the width and/or length of the femur and tibia) and secondary delays in physical development and reproductive organ immaturity at doses greater than or equal to 2 mg/kg (approximately 1.2 to 5 times the human exposure based on auc at the recommended clinical dose of 24 mg). decreased length of the femur and tibia persisted following 4 weeks of recovery. in general, the toxicologic profile of lenvatinib was similar between juvenile and adult rats, though toxicities including broken teeth at all dose levels and mortality at the 10 mg/kg/day dose level (attributed to primary duodenal lesions) occurred at earlier treatment time-points in juvenile rats. of the 261 patients with differentiated thyroid cancer (dtc) who received lenvima in select, 45% were ≥65 years of age and 11% were ≥75 years of age. no overall differences in safety or effectiveness were observed between these subjects and younger subjects. of the 352 patients with renal cell carcinoma (rcc) who received lenvima with pembrolizumab in clear, 45% were ≥65 years of age and 13% were ≥75 years of age. no overall differences in safety or effectiveness were observed between these elderly patients and younger patients.   of the 62 patients with rcc who received lenvima with everolimus in study 205, 36% were ≥65 years of age. conclusions are limited due to the small sample size, but there appeared to be no overall differences in safety or effectiveness between these subjects and younger subjects.  of the 476 patients with hepatocellular carcinoma (hcc) who received lenvima in reflect, 44% were ≥65 years of age and 12% were ≥75 years of age. no overall differences in safety or effectiveness were observed between patients ≥65 and younger subjects. patients ≥75 years of age showed reduced tolerability to lenvima. of 406 adult patients with endometrial carcinoma (ec) who were treated with lenvima in combination with pembrolizumab in study 309, 201 (50%) were 65 years and over. no overall differences in safety or effectiveness were observed between elderly patients and younger patients. no dose adjustment is recommended for patients with mild (clcr 60-89 ml/min) or moderate (clcr 30-59 ml/min) renal impairment. lenvatinib concentrations may increase in patients with dtc, rcc, or endometrial carcinoma and severe (clcr 15-29 ml/min) renal impairment. reduce the dose of lenvatinib for patients with rcc, dtc, or endometrial carcinoma and severe renal impairment [see dosage and administration   ( 2.7 )] . there is no recommended dose of lenvima for patients with hcc and severe renal impairment. lenvima has not been studied in patients with end stage renal disease [ see warnings and precautions ( 5.5 ) , clinical pharmacology ( 12.3 ) ] . no dose adjustment is recommended for patients with hcc and mild hepatic impairment (child-pugh a). there is no recommended dose for patients with hcc with moderate or severe hepatic impairment.  no dose adjustment is recommended for patients with dtc, rcc, or endometrial carcinoma and mild or moderate hepatic impairment (child-pugh a or b). lenvatinib concentrations may increase in patients with dtc, rcc, or endometrial carcinoma and severe hepatic impairment (child-pugh c). reduce the dose of lenvatinib for patients with dtc, rcc, or endometrial carcinoma and severe hepatic impairment [see dosage and administration ( 2.7 ) , clinical pharmacology ( 12.3 ) ] .

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

eisai australia pty ltd - lenvatinib mesilate, quantity: 12.25 mg (equivalent: lenvatinib, qty 10 mg) - capsule, hard - excipient ingredients: microcrystalline cellulose; iron oxide yellow; purified talc; iron oxide red; calcium carbonate; propylene glycol; hyprolose; mannitol; potassium hydroxide; titanium dioxide; hypromellose; iron oxide black; shellac - endometrial carcinoma lenvima, in combination with pembrolizumab, is indicated for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (msi-h) or mismatch repair deficient (dmmr), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation., differentiated thyroid cancer (dtc) lenvima is indicated for the treatment of patients with progressive, locally advanced or metastatic, radioactive iodine (rai) refractory differentiated thyroid cancer (dtc).,renal cell carcinoma (rcc) lenvima, in combination with pembrolizumab, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (rcc).,lenvima, in combination with everolimus, is indicated for the treatment of adult patients with advanced renal cell carcinoma (rcc) whose disease has progressed following one prior vascular endothelial growth factor targeted therapy.,hepatocellular carcinoma (hcc) lenvima is indicated for the first-line treatment of patients with unresectable hepatocellular carcinoma (hcc).

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

eisai australia pty ltd - lenvatinib mesilate, quantity: 4.9 mg (equivalent: lenvatinib, qty 4 mg) - capsule, hard - excipient ingredients: iron oxide yellow; propylene glycol; potassium hydroxide; mannitol; iron oxide black; titanium dioxide; hypromellose; purified talc; iron oxide red; calcium carbonate; microcrystalline cellulose; hyprolose; shellac - endometrial carcinoma lenvima, in combination with pembrolizumab, is indicated for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (msi-h) or mismatch repair deficient (dmmr), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.,differentiated thyroid cancer (dtc) lenvima is indicated for the treatment of patients with progressive, locally advanced or metastatic, radioactive iodine (rai) refractory differentiated thyroid cancer (dtc).,renal cell carcinoma (rcc) lenvima, in combination with pembrolizumab, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (rcc).,lenvima, in combination with everolimus, is indicated for the treatment of adult patients with advanced renal cell carcinoma (rcc) whose disease has progressed following one prior vascular endothelial growth factor targeted therapy.,hepatocellular carcinoma (hcc) lenvima is indicated for the first-line treatment of patients with unresectable hepatocellular carcinoma (hcc).

Nova Zelândia - inglês - Medsafe (Medicines Safety Authority)

eisai new zealand limited - lenvatinib mesilate 12.25mg equivalent to lenvatinib 10mg - capsule - 10 mg - active: lenvatinib mesilate 12.25mg equivalent to lenvatinib 10mg excipient: calcium carbonate hyprolose as 25mg low-substituted hydroxypropyl cellulose + 3mg hydroxypropylcellulose hypromellose iron oxide black iron oxide red iron oxide yellow mannitol microcrystalline cellulose potassium hydroxide propylene glycol purified talc shellac titanium dioxide - lenvima is indicated for the treatment of patients with progressive, locally advanced or metastatic, radioactive iodine refractory differentiated thyroid cancer.

Nova Zelândia - inglês - Medsafe (Medicines Safety Authority)

eisai new zealand limited - lenvatinib mesilate 4.9mg equivalent to lenvatinib 4mg - capsule - 4 mg - active: lenvatinib mesilate 4.9mg equivalent to lenvatinib 4mg excipient: calcium carbonate hyprolose as 25mg low-substituted hydroxypropyl cellulose + 3mg hydroxypropylcellulose hypromellose iron oxide black iron oxide red iron oxide yellow mannitol microcrystalline cellulose potassium hydroxide propylene glycol purified talc shellac titanium dioxide - lenvima is indicated for the treatment of patients with progressive, locally advanced or metastatic, radioactive iodine refractory differentiated thyroid cancer.

Canadá - inglês - Health Canada

eisai limited - lenvatinib (lenvatinib mesylate) - capsule - 24mg - lenvatinib (lenvatinib mesylate) 24mg - antineoplastic agents

Canadá - inglês - Health Canada

eisai limited - lenvatinib (lenvatinib mesylate) - capsule - 20mg - lenvatinib (lenvatinib mesylate) 20mg - antineoplastic agents

Canadá - inglês - Health Canada

eisai limited - lenvatinib (lenvatinib mesylate) - capsule - 14mg - lenvatinib (lenvatinib mesylate) 14mg - antineoplastic agents

Canadá - inglês - Health Canada

eisai limited - lenvatinib (lenvatinib mesylate) - capsule - 10mg - lenvatinib (lenvatinib mesylate) 10mg - antineoplastic agents

Canadá - inglês - Health Canada

eisai limited - lenvatinib (lenvatinib mesylate) - capsule - 8mg - lenvatinib (lenvatinib mesylate) 8mg - antineoplastic agents