Lenvima

Lenvima

lenvatinib

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/ pembrolizumab for 1st-line treatment of advanced renal cell carcinoma (RCC). In combination w/ everolimus for advanced 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 or recurrent endometrial carcinoma who have disease progression on or following prior platinum-based therapy in any setting & are not candidates for curative surgery or radiation.
Dosage/Direction for Use
Adult DTC 24 mg once daily. RCC Combination w/ pembrolizumab: 20 mg once daily w/ pembrolizumab 200 mg IV infusion over 30 min every 3 wk. Combination w/ everolimus: 18 mg once daily w/ everolimus 5 mg once daily. HCC Patient <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 or 400 mg every 6 wk. Severe hepatic & renal impairment DTC 14 mg once daily. RCC & 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. 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; in the event of nephrotic syndrome. Posterior reversible encephalopathy syndrome/reversible posterior leucoencephalopathy syndrome; HTN or history of aneurysm; arterial thromboembolism w/in previous 6 mth; haemorrhage; GI perforation & fistula formation; dehydration &/or hypovolemia due to GI toxicity; wound healing complications; osteonecrosis of the jaw. Ensure BP control & stable antihypertensive therapy for at least 1 wk prior to treatment. Consider 4-wk washout period following sorafenib or other anticancer treatments due to potential risk for additive toxicities. 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 LFT 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. Perform dental exam & appropriate preventive dentistry prior to treatment. Patients <60 kg, ECOG performance status ≥2, Caucasian or Asian patients. May affect ability to drive & use machines. Concomitant use w/ antiresorptive therapy, other angiogenesis inhibitors. Hepatic & renal impairment or failure. Not recommended in ESRD. Women of childbearing potential should use highly 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 to <18 yr. Elderly ≥75 yr.
Adverse Reactions
UTI; thrombocytopenia, lymphopenia, leukopenia, neutropenia; hypothyroidism; increased blood TSH; hypocalcaemia, hypercholesterolaemia, hypokalaemia, hypomagnesaemia, decreased appetite & wt, dehydration; insomnia; dizziness, headache, dysgeusia; haemorrhage, HTN, hypotension; dysphonia; diarrhoea, GI & abdominal pain, vomiting, nausea, oral inflammation & pain, constipation, dyspepsia, dry mouth, increased lipase & amylase; increased blood bilirubin & alkaline phosphatase, ALT, AST & γ-glutamyltransferase, hypoalbuminaemia; palmar-plantar erythrodysaesthesia syndrome, rash, alopecia; back pain, arthralgia, myalgia, pain in extremity, musculoskeletal pain; proteinuria, increased blood creatinine; fatigue, asthenia, peripheral oedema. Dehydration; MI, ECG prolonged QT; pulmonary embolism; flatulence; abnormal hepatic function, cholecystitis; hyperkeratosis; renal failure, increased blood urea; malaise. Monotherapy/combination w/ everolimus: CVA; cardiac failure, decreased ejection fraction; anal fistula; hepatic failure & encephalopathy; palmar erythema; renal impairment. Combination w/ pembrolizumab: Anaemia; hyperthyroidism; pancreatitis, colitis.
Drug Interactions
Reduced hormonal contraceptive effectiveness.
MIMS Class
Targeted Cancer Therapy
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
20's
Form
Lenvima hard cap 4 mg
Packing/Price
20's
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