Lenvima

Lenvima

lenvatinib

Manufacturer:

Eisai

Distributor:

DKSH
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Lenvatinib
Indications/Uses
Treatment of patients w/ locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC). In combination w/ everolimus for the treatment of patients w/ advanced renal cell carcinoma (RCC) following 1 prior anti-angiogenic therapy. 1st-line treatment of patients w/ unresectable hepatocellular carcinoma (HCC). In combination w/ pembrolizumab for the treatment of patients w/ advanced endometrial carcinoma (EC) 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 once daily. Severe renal impairment (CrCl <30 mL/min) or severe hepatic impairment (Child-Pugh C) 14 mg once daily. RCC 18 mg in combination w/ 5 mg everolimus once daily. Severe renal impairment (CrCl <30 mL/min) or severe hepatic impairment (Child-Pugh C) 10 mg once daily. HCC Patients ≥60 kg 12 mg once daily, <60 kg 8 mg once daily. EC 20 mg orally once daily, in combination w/ pembrolizumab 200 mg administered as IV infusion over 30 min every 3 wk. Severe renal impairment (CrCl <30 mL/min) or severe hepatic impairment (Child-Pugh C) 10 mg once daily.
Administration
May be taken with or without food: Take at the same time each day. Swallow whole w/ liqd. 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.
Special Precautions
Control BP prior to treatment initiation & monitor after 1 wk, then every 2 wk for the 1st 2 mth, & mthly thereafter. Monitor patients for clinical symptoms or signs of cardiac dysfunction. Monitor liver function prior to treatment initiation, then every 2 wk for the 1st 2 mth, & mthly thereafter. Risk of renal failure or impairment; initiate prompt management of diarrhea or dehydration/hypovolemia. Monitor for proteinuria prior to treatment initiation & periodically thereafter. Monitor ECG in patients w/ congenital long QT syndrome, CHF, bradyarrhythmias, or those taking drugs known to prolong QT interval including class Ia & III antiarrhythmics. Monitor blood Ca levels at least mthly & replace Ca as necessary. Discontinue permanently following an arterial thrombotic event; or GI perforation of any severity or Grade 3 or 4 fistula. Reversible posterior leukoencephalopathy syndrome (RPLS). Hemorrhagic events. Monitor thyroid function prior to treatment initiation & at least mthly thereafter. Impaired wound healing; withhold treatment for at least 1 wk prior to scheduled surgery; do not administer for at least 2 wk following major surgery & until adequate wound healing. Patients w/ severe renal or hepatic impairment. May impair fertility. Pregnancy. Can cause fetal harm. Advise females of reproductive potential to use effective contraception during treatment & for at least 30 days after last dose. Discontinue breastfeeding during treatment & for at least 1 wk after the last dose. Ped patients.
Adverse Reactions
HTN, fatigue, diarrhea, arthralgia/myalgia, decreased appetite & wt, nausea, stomatitis, headache, vomiting, proteinuria, palmar-plantar erythrodysesthesia (PPE) syndrome, abdominal pain, dysphonia; pneumonia, dehydration; asthenia.
Drug Interactions
Avoid coadministration w/ medicinal products w/ known potential to prolong QT/QTc interval.
ATC Classification
L01EX08 - lenvatinib ; Belongs to the class of other protein kinase inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Lenvima cap 10 mg
Packing/Price
20's
Form
Lenvima cap 4 mg
Packing/Price
20's
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