Your Health, We Care
Another Name乐伐替尼,仑伐替尼,乐卫玛,Lenvima,E7080
IndicationsLenvatinib is a broad-spectrum anti-cancer drug.
Reg No.03 L 1079/24
Inspection NO.0557-24
There are two different specifications of Lenvatinib drugs: one is a box of 30 pills, each pill is 4 milligrams, and its price is about 450 yuan;
Another option is to have 30 pills per box, but each pill is 10 milligrams, and its price is around 900 yuan.
Lenvatinib, as a multi-target inhibitor, aims to achieve anti-tumor effects by inhibiting the activity of various kinases related to tumor growth and angiogenesis.
Lenvatinib
Lenvatinib is a broad-spectrum anti-cancer drug.
Based on findings from animal studies and its mechanism of action, lenvatinib can cause fetal harm when administered to a pregnant woman. 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. There are no available human data informing the drug-associated risk. Advise pregnant women of the potential risk to a fetus.
It is not known whether lenvatinib is present in human milk; however, lenvatinib and its metabolites are excreted in rat milk at concentrations higher than those in maternal plasma. Because of the potential for serious adverse reactions in breastfed children, advise women to discontinue breastfeeding during treatment with lenvatinib and for 1 week after the last dose.
Based on animal data and its mechanism of action, lenvatinib can cause fetal harm when administered to a pregnant woman.
Pregnancy Testing
Verify the pregnancy status of females of reproductive potential prior to initiating lenvatinib.
Contraception
Females
Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment with lenvatinib and for 30 days after the last dose.
Infertility
lenvatinib may impair fertility in males and females of reproductive potential.
The safety and effectiveness of lenvatinib in pediatric patients have not been established.
Of the 261 patients with differentiated thyroid cancer (DTC) who received lenvatinib 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 lenvatinib 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 476 patients with hepatocellular carcinoma (HCC) who received lenvatinib 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 lenvatinib.
Of 406 adult patients with endometrial carcinoma (EC) who were treated with lenvatinib 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. There is no recommended dose of lenvatinib for patients with HCC and severe renal impairment. lenvatinib has not been studied in patients with end stage renal disease.
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.
Due to the high plasma protein binding, lenvatinib is not expected to be dialyzable. Death due to multiorgan dysfunction occurred in a patient who received a single dose of lenvatinib 120 mg orally.
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
The time to peak plasma concentration (Tmax) typically occurred from 1 to 4 hours post-dose.
from FDA，2024.06
