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Lenvima

Lenvima

Manufacturer:

Eisai

Distributor:

DKSH
Concise Prescribing Info
Contents
Lenvatinib
Indications/Uses
Progressive, locally advanced or metastatic, differentiated thyroid carcinoma (DTC), refractory to radioactive iodine (RAI). In combination w/ everolimus for advanced renal cell carcinoma (RCC) following 1 prior vascular endothelial growth factor-targeted therapy. Monotherapy for advanced or unresectable hepatocellular carcinoma (HCC) in adults who have received no prior systemic therapy. In combination w/ pembrolizumab for adults w/ advanced endometrial carcinoma not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior platinum-based systemic therapy & are not candidates for curative surgery or radiation.
Dosage/Direction for Use
Adult DTC 24 mg once daily. RCC 18 mg once daily in combination w/ everolimus 5 mg once daily. HCC <60 kg 8 mg once daily, ≥60 kg 12 mg once daily. Endometrial carcinoma 20 mg once daily in combination w/ pembrolizumab 200 mg IV infusion over 30 min every 3 wk. Severe hepatic & renal impairment DTC Initially 14 mg once daily. RCC Initially 10 mg in combination w/ everolimus 5 mg once daily. Endometrial carcinoma Initially 10 mg once daily.
Administration
May be taken with or without food: Take at the same time each day. Swallow whole w/ water. May add cap to a spoonful of water or apple juice in a small glass to produce a susp. Cap must be left in the liqd for at least 10 min & stirred for at least 3 min to dissolve cap shells. Rinse glass w/ the same amount of water or apple juice & drink.
Contraindications
Special Precautions
Discontinue use in patients w/ oesophageal or tracheobronchial tract involvement & any Grade 4 fistula; persistent Grade 4 diarrhoea occurs. Posterior reversible encephalopathy syndrome/reversible posterior leucoencephalopathy syndrome; HTN or history of aneurysm; dehydration &/or hypovolemia due to GI toxicity; arterial thromboembolism w/in previous 6 mth; haemorrhage; GI perforation & fistulae formation; wound healing complications. Ensure BP control & stable antihypertensive therapy for at least 1 wk prior to treatment. Monitor BP after 1 wk of initiation, then every 2 wk for 1st 2 mth & mthly thereafter & urine protein regularly. Monitor clinical symptoms or signs of cardiac decompensation. Monitor liver function test prior to, then every 2 wk for 1st 2 mth & mthly thereafter. Periodic monitoring of ECG & electrolytes (Mg, K & Ca) in patients w/ congenital long QT syndrome, CHF, bradyarrhythmia & taking concomitant drugs prolonging QT interval. Monitor thyroid function & TSH levels prior to & periodically throughout therapy. Patients <60 kg, ECOG performance status ≥2, Caucasian or Asian patients. May affect ability to drive & use machines. Hepatic & renal impairment or failure. Not recommended in end-stage renal disease. Women of childbearing potential should use effective contraception during & at least 1 mth after treatment. Not to be used during pregnancy. Not to be used in childn <2 yr; childn 2-<18 yr. Elderly ≥75 yr.
Adverse Reactions
UTI; thrombocytopenia, leukopenia, neutropenia, lymphopenia; hypothyroidism; decreased wt & appetite; headache; haemorrhage, HTN; diarrhea, nausea, vomiting, abdominal pain, constipation; dysphonia; palmar-plantar erythrodysaesthesia syndrome, rash; musculoskeletal pain; fatigue; hypomagnesaemia. DTC, RCC, HCC: Increased blood TSH; hypercholesterolaemia, hypocalcaemia, hypokalaemia; insomnia; dizziness, dysgeusia; hypotension; GI pain, oral inflammation & pain, dyspepsia, dry mouth; hypoalbuminaemia, increased AST, ALT & blood bilirubin; palmar erythema, alopecia; back pain, arthralgia, myalgia, pain in extremity; proteinuria; asthenia, peripheral oedema. Dehydration; CVA; MI, cardiac failure, prolonged ECG QT, decreased ejection fraction; pulmonary embolism; anal fistula, flatulence, increased lipase & amylase; hepatic failure & encephalopathy, increased blood alkaline phosphatase, γ-glutamyltransferase, abnormal hepatic function, cholecystitis; hyperkeratosis; renal failure & impairment, increased blood creatinine & urea; malaise. Endometrial carcinoma: Stomatitis; dyspnea, cough; laboratory abnormalities; anemia, increased INR.
Drug Interactions
Reduced hormonal contraceptive effectiveness.
ATC Classification
L01XE29 - lenvatinib ; Belongs to the class of protein kinase inhibitors, other antineoplastic agents. Used in the treatment of cancer.
Presentation/Packing
Form
Lenvima hard cap 10 mg
Packing/Price
20's
Form
Lenvima hard cap 4 mg
Packing/Price
20's
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