LENVIMA Capsules
Lenvatinib
4mg
EISAI EUROPE LIMITED
| Pack size | 30's (10's Blister x 3) |
|---|---|
| Dispensing mode | POM |
| Source | UK |
| Agent | Modern Pharmaceutical Co. |
| Retail Price | 11300.50 AED |
Available as:
Indications
LENVIMA Capsules is used for:
Patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated, thyroid cancer. In combination with everolimus for the treatment of patients with, advanced renal cell carcinoma, following 1 prior vascular endothelial growth factor-targeted therapy.
Adult Dose
Adult Differentiated thyroid cancer (DTC) 24 mg once daily.
Renal cell carcinoma (RCC) 18 mg in combination w/ everolimus 5 mg once daily.
Patient w/ severe hepatic impairment
Initially 14 mg once daily for DTC.
10 mg once daily for RCC.
Child Dose
Renal Dose
Patient w/ severe renal impairment
Initially 14 mg once daily for DTC.
10 mg once daily for RCC.
Administration
Swallow capsule whole
May take with or without food
Take at the same time each day
Contra Indications
Hypersensitivity. Lactation.
Precautions
Monitor BP after 1 wk of treatment then every 2 wk for the 1st 2 month & monthly thereafter. Monitor urine protein regularly. Actively managed GI toxicity to reduce the risk of development of renal impairment/renal failure. Monitor for clinical symptoms or signs of cardiac decompensation. Posterior reversible encephalopathy syndrome/reversible posterior leucoencephalopathy syndrome. Monitor liver function tests before initiation of treatment, then every 2 wk for the 1st 2 month & monthly thereafter during treatment. Adjust initial dose in patients w/ severe renal or hepatic impairment.
Serious tumour-related bleeds including fatal haemorrhagic events, GI perforation & fistula formation may occur. Patients w/ arterial thromboembolic event w/in the previous 6 month. Consider periodic monitoring of ECG & electrolytes during treatment. Monitor TSH levels. Discontinue use in the event of persistence of GI perforation or fistula & grade 4 diarrhoea. Patients of ethnic origin other than Caucasian or Asian. Not recommended in patients w/ end-stage renal disease. May affect the ability to drive or operate machinery. Women of childbearing potential must use highly effective contraception while taking & 1 month after stopping treatment. Do not use during pregnancy. Do not use in child <2 yr. Elderly >75 yr.
Lactation
Unknown if distributed in human breast milk; advise women to discontinue breastfeeding during treatment because of the potential for serious adverse reactions in nursing infants
Lenvatinib and its metabolites are excreted in rat milk at concentrations higher than in maternal plasma (approximately 2 times higher [based on AUC] in milk compared with maternal plasma
Pregnancy-Lactation
Pregnancy
Based on its mechanism of action and data from animal reproduction studies, lenvatinib can cause fetal harm when administered to a pregnant woman; verify the pregnancy status of females of reproductive potential prior to initiating
In animal reproduction studies, oral administration during organogenesis at doses below the recommended human dose (approximately 0.14 times the recommended human dose based on body surface area) 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
Contraception
Advise females of reproductive potential to use effective contraception during treatment and for at least 30 days after last dose
Infertility
Females: May result in reduced fertility in females of reproductive potential
Males: May result in damage to male reproductive tissues, leading to reduced fertility of unknown duration
Lactation
Unknown if distributed in human breast milk; because of the potential for serious adverse reactions in nursing infants, advise women to discontinue breastfeeding during treatment and for at least 1 week after last dose
Lenvatinib and its metabolites are excreted in rat milk at concentrations higher than in maternal plasma (~2 times higher [based on AUC]) in milk compared with maternal plasma
Interactions
Decreased exposure w/ oral CYP3A4/Pgp substrates [eg, astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil or ergot alkaloids (ergotamine, dihydroergotamine)]. May reduce effectiveness of oral hormonal contraceptives.
Adverse Effects
Side effects of Lenvatinib :
>10%
Percentages are for all grades of adverse effects unless otherwise noted
Hypertension (73%), Diarrhea (67%), Fatigue (67%), Arthralgia/myalgia (62%), Decreased appetite (54%), Weight decreased (51%), Nausea (47%), Hypertension, grades 3-4 (44%), Stomatitis (41%), Headache (38%), Vomiting (36%), Proteinuria (34%), Palmar-plantar erythrodysesthesia (32%), Abdominal pain (31%), Dysphonia (31%), Constipation (29%), Oral pain (25%), Cough (24%), Peripheral edema (21%), Rash (21%), Dysgeusia (18%), Dry mouth (17%), Dizziness (15%), Dyspepsia (13%), Alopecia (12%), Epistaxis (12%), Insomnia (12%), Urinary tract infection (11%)
1-10%
Percentages are for all grades of adverse effects unless otherwise noted
Dental infections (10%)
Hypotension (9%)
Diarrhea, grades 3-4 (9%)
Dehydration (9%)
Prolonged QT interval (9%)
Hypocalcemia (9%)
Decreased appetite, grades 3-4 (7%)
Hyperkeratosis (7%)
Hypokalemia (6%)
AST increased (5%)
ALT increased (4%)
Lipase increased (4%)
Creatinine increased (3%)
Nausea, grades 3-4 (2%)
Platelet count decreased (2%)
Mechanism of Action
Receptor tyrosine kinase (RTK) inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4)
Also inhibits other RTKs that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1, 2, 3, and 4; the platelet-derived growth factor receptor alpha (PDGFR-alpha), KIT, and RET
Note
LENVIMA 4mg Capsules manufactured by EISAI EUROPE LIMITED. Its generic name is Lenvatinib. LENVIMA is availble in United Arab Emirates.
Farmaco UAE drug index information on LENVIMA Capsules is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.