Lenvima

Lenvima

lenvatinib

Manufacturer:

Eisai

Distributor:

DKSH
Concise Prescribing Info
Contents
Lenvatinib mesilate
Indications/Uses
Monotherapy in adults w/ progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI). Monotherapy in adults w/ advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy. In combination w/ everolimus for adults w/ advanced renal cell carcinoma (RCC) following 1 prior vascular endothelial growth factor (VGEF)-targeted therapy. In combination w/ pembrolizumab for patients w/ advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H)  or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy & are not candidates for curative surgery or radiation.
Dosage/Direction for Use
DTC 24 mg (two 10 mg cap & one 4 mg cap) once daily. Dose modification: 1st dose reduction: 20 mg (two 10 mg cap) once daily. 2nd dose reduction: 14 mg (one 10 mg cap & one 4 mg cap) once daily. 3rd dose reduction: 10 mg once daily. RCC 18 mg (one 10 mg cap & two 4 mg cap) once daily in combination w/ 5 mg everolimus once daily. Dose modification: 1st dose reduction: 14 mg (one 10 mg cap & one 4 mg cap) once daily. 2nd dose reduction: 10 mg once daily. 3rd dose reduction: 8 mg (two 4 mg cap) once daily. HCC Patient weighing ≥60 kg 12 mg (three 4 mg cap) once daily. Dose modification: 1st occurrence: 8 mg (two 4 mg cap) once daily. 2nd occurrence: 4 mg (one 4 mg cap) once daily. 3rd occurrence: 4 mg every other day. <60 kg 8 mg (two 4 mg cap) once daily. Dose modification: 1st occurrence: 4 mg (one 4 mg cap) once daily. 2nd occurrence: 4 mg every other day. Endometrial carcinoma 20 mg once daily in combination w/ 200 mg pembrolizumab via IV infusion over 30 min every 3 wk until unacceptable toxicity or disease progression. Dose modification: 1st dose reduction: 14 mg (one 10 mg cap & one 4 mg cap) once daily. 2nd dose reduction: 10 mg once daily. 3rd dose reduction: 8 mg (two 4 mg cap) once daily. Patient w/ severe (Child-Pugh C) hepatic & severe renal impairment DTC Initially 14 mg once daily. RCC Initially 10 mg once daily in combination w/ everolimus once daily. Endometrial carcinoma 10 mg once daily.
Administration
May be taken with or without food: Take at the same time each day. Swallow whole w/ water, do not open the cap to avoid repeated exposure. Alternatively, add the cap to a tbsp of water or apple juice in a small glass to produce a suspension. Do not crush/break the cap. Leave for at least 10 min. Stir susp for at least 3 min & drink immediately. Rinse glass w/ another 1 tbsp of water or apple juice. Swirl a few times & swallow the additional liqd.
Contraindications
Special Precautions
Control BP & ensure stable antihypertensive therapy dose in hypertensive patients for at least 1 wk prior to treatment. Monitor BP after 1 wk of treatment, then every 2 wk for the first 2 mth, & mthly thereafter. Withhold therapy if BP level is ≥160 mmHg systolic BP or ≥100 mmHg diastolic BP despite optimal antihypertensive therapy, & in QT interval prolongation >500 ms & resume at a reduced dose when QTc prolongation is resolved to <480 ms or baseline. Monitor urine protein regularly; liver function tests before initiation of treatment, then every 2 wk for the first 2 mth & mthly thereafter during treatment; patients w/ HCC for worsening liver function including hepatic encephalopathy; for cardiac decompensation; ECG at baseline & periodically during treatment especially in patients w/ congenital long QT syndrome, CHF, bradyarrhythmias, & those taking drugs known to prolong QT interval eg, class Ia & III antiarrhythmics. Renal impairment or failure; potential higher risk for acute renal failure in patients receiving agents acting on the renin-angiotensin aldosterone system. Adjust the initial dose for patients w/ severe renal impairment. Prompt medical management of diarrhoea to prevent dehydration. Hepatic failure & acute hepatitis in patients w/ DTC. Higher risk of developing hepatic encephalopathy & hepatic failure in patients w/ worse hepatic impairment &/or greater liver tumour burden at baseline. Discontinue use in nephrotic syndrome, persistent grade 4 diarrhoea, arterial thrombotic event. Posterior reversible encephalopathy syndrome or reversible posterior leucoencephalopathy syndrome (RPLS). Patients who had arterial thromboembolism w/in the previous 6 mth. Potential risk of severe haemorrhage associated w/ tumour shrinkage/necrosis following therapy. Perform screening & subsequent treatment of oesophageal varices in patients w/ liver cirrhosis before treatment. GI perforation & fistulae in patients w/ risk factors eg, prior surgery or radiotherapy. Do not start treatment in patients w/ fistula. Permanently discontinue in patients w/ oesophageal or tracheobronchial tract involvement & any Grade 4 fistula. Monitor electrolytes eg, Mg, K & Ca periodically during treatment & correct electrolyte abnormalities before treatment; blood Ca levels at least mthly & replace Ca as necessary during treatment; thyroid function before initiation of, & periodically throughout treatment, & TSH levels regularly. Consider temporary interruption in patients undergoing major surgical procedures. Minor influence on the ability to drive & use machines. End-stage renal disease, severe renal & hepatic impairment (Child-Pugh C). Women of childbearing potential must use highly effective contraception during treatment & for 1 mth after stopping treatment. Pregnancy. Contraindicated during breastfeeding. Caucasian or Asian. Patients weighing <60 kg w/ RCC. Paed <2 yr, 2 to <18 yr. Elderly ≥75 yr.
Adverse Reactions
UTI; thrombocytopenia, leukopenia, neutropenia; hypothyroidism, increased blood TSH; hypocalcaemia, hypercholesterolaemia, hypokalaemia, decreased appetite & wt; insomnia; dizziness, headache, dysgeusia; haemorrhage, HTN, hypotension; dysphonia; diarrhoea, GI & abdominal pains, vomiting, nausea, oral inflammation & pain, constipation, dyspepsia, dry mouth; hypoalbuminaemia, increased AST, ALT & blood bilirubin; palmar-plantar erythrodysaesthesia syndrome, palmar erythema, rash, alopecia; back pain, arthralgia, myalgia, pain in extremity, musculoskeletal pain; proteinuria; fatigue, asthenia, peripheral oedema. Lymphopenia; dehydration, hypomagnesaemia; CVA, PRES, transient ischaemic attack; MI, cardiac failure, prolonged ECG QT, decreased ejection fraction; pulmonary embolism, pneumothorax; anal fistula, flatulence, increased lipase & amylase, pancreatitis; hepatic failure & encephalopathy, increased blood alkaline phosphatase, abnormal hepatic function, increased γ-glutamyl transferase, cholecystitis; hyperkeratosis; renal failure & impairment, increased blood creatinine & urea; malaise, non-GI fistula, impaired healing.
Drug Interactions
May reduce the effectiveness of hormonal contraceptives.
ATC Classification
L01EX08 - lenvatinib ; Belongs to the class of other protein kinase inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Lenvima hard cap 10 mg
Packing/Price
2 × 10's
Form
Lenvima hard cap 4 mg
Packing/Price
2 × 10's
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