Lenvima

Lenvatinib

Treatment of patients w/ locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC). In combination w/ pembrolizumab for the 1st-line treatment of adults w/ advanced renal cell carcinoma (RCC). In combination w/ everolimus for the treatment of adults w/ advanced 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 mismatch repair proficient (pMMR), as determined by a validated test, or not microsatellite instability-high (MSI-H), who have disease progression following prior systemic therapy in any setting & are not candidates for curative surgery or radiation.

DTC 24 mg once daily until disease progression or unacceptable toxicity. Patient w/ severe renal impairment (CrCl <30 mL/min) or severe hepatic impairment (Child-Pugh C) 14 mg once daily. RCC 1st-line treatment: 20 mg orally once daily, in combination w/ 200 mg pembrolizumab as IV infusion over 30 min every 3 wk, until disease progression or unacceptable toxicity or up to 2 yr. After completing 2 yr of combination therapy, Lenvima may be administered as a single agent until disease progression or unacceptable toxicity. Previously treated: 18 mg once daily, in combination w/ 5 mg everolimus orally, until disease progression or unacceptable toxicity. Patient w/ severe renal impairment (CrCl <30 mL/min) or severe hepatic impairment (Child-Pugh C) 10 mg once daily. HCC Patient weighing ≥60 kg 12 mg once daily until disease progression or unacceptable toxicity, <60 kg 8 mg once daily until disease progression or unacceptable toxicity. EC 20 mg orally once daily, in combination w/ 200 mg pembrolizumab as IV infusion over 30 min every 3 wk, until disease progression or unacceptable toxicity. Patient w/ severe renal impairment (CrCl <30 mL/min) or severe hepatic impairment (Child-Pugh C) 10 mg once daily.

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.

Control BP prior to treatment initiation & monitor after 1 wk, then every 2 wk for the 1st 2 mth, & at least mthly thereafter during treatment. Monitor patients for clinical symptoms or signs of cardiac dysfunction. Permanently discontinue following an arterial thrombotic event. Has not been studied in patients who have had arterial thromboembolic event w/in the previous 6 mth. Monitor liver function prior to treatment initiation, then every 2 wk for the 1st 2 mth, & at least mthly thereafter during treatment. Closely monitor patients w/ HCC for signs of hepatic failure, including hepatic encephalopathy. Risk of renal failure or impairment. Initiate prompt management of diarrhea or dehydration/hypovolemia. Monitor for proteinuria prior to treatment initiation & periodically during treatment. Permanently discontinue in patients who develop GI perforation of any severity or Grade 3 or 4 fistula. Monitor & correct electrolyte abnormalities at baseline & periodically during treatment. 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 during treatment. Risk of reversible posterior leukoencephalopathy syndrome. Risk of hemorrhagic events. Impairs exogenous thyroid suppression. Monitor thyroid function prior to treatment initiation & at least mthly during treatment. Reports of impaired wound healing. W/hold for at least 1 wk prior to elective surgery & do not administer for at least 2 wk following major surgery & until adequate wound healing. Resumption after resolution of wound healing complications has not been established. Reports of osteonecrosis of the jaw. Perform oral exam prior to & periodically during treatment & advise patients on good oral hygiene practices. Avoid invasive dental procedures while on treatment or w/hold for at least 1 wk prior to scheduled dental surgery or invasive dental procedures. May promote formation of aneurysms &/or artery dissections in patients w/ or w/o HTN. Has not been studied in patients w/ ESRD. No recommended dose for patients w/ HCC & severe renal impairment, & HCC & moderate or severe hepatic impairment. Can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment & for at least 30 days after the last dose. May impair fertility. Discontinue breastfeeding during treatment & for at least 1 wk after the last dose. Safety & effectiveness in ped patients have not been established.

DTC: HTN, fatigue, diarrhea, arthralgia/myalgia, decreased appetite, decreased wt, nausea, stomatitis, headache, vomiting, proteinuria, palmar-plantar erythrodysesthesia (PPE) syndrome, abdominal pain, dysphonia. 1st-line treatment of RCC in combination w/ pembrolizumab: Fatigue; diarrhea, stomatitis, nausea, abdominal pain, vomiting, constipation; musculoskeletal pain; hypothyroidism; HTN, hemorrhagic events; decreased appetite; rash, PPE syndrome; dysphonia; proteinuria, acute kidney injury; decreased wt; hepatotoxicity; headache. Previously treated RCC in combination w/ everolimus: Diarrhea, fatigue, arthralgia/myalgia, decreased appetite, vomiting, nausea, stomatitis/oral inflammation, HTN, peripheral edema, cough, abdominal pain, dyspnea, rash, decreased wt, hemorrhagic events, proteinuria. HCC: HTN, fatigue, diarrhea, decreased appetite, arthralgia/myalgia, decreased wt, abdominal pain, PPE syndrome, proteinuria, dysphonia, hemorrhagic events, hypothyroidism, nausea. EC: Hypothyroidism; HTN, hemorrhagic events; fatigue; diarrhea, nausea, vomiting, stomatitis, abdominal pain, constipation; musculoskeletal disorders; decreased appetite; decreased wt; proteinuria; UTI; headache; dysphonia; PPE syndrome, rash.

Avoid co-administration w/ medicinal products w/ known potential to prolong QT/QTc interval.

Targeted Cancer Therapy

L01EX08 - lenvatinib ; Belongs to the class of other protein kinase inhibitors. Used in the treatment of cancer.

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