Lenvima

Lenvatinib

Unresectable thyroid cancer (TC); hepatocellular carcinoma (HCC). In combination w/ pembrolizumab for 1st-line treatment of patients w/ advanced renal cell carcinoma (RCC) & for treatment of patients w/ advanced endometrial carcinoma (EC) who have disease progression following prior systemic therapy in any setting & are not candidates for curative surgery or radiation. In combination w/ everolimus for advanced RCC following 1 prior anti-angiogenic therapy.

TC Initially 24 mg once daily. Dose modification: 1st dose reduction to: 20 mg once daily; 2nd dose reduction to: 14 mg once daily; 3rd dose reduction to: 10 mg once daily. RCC Initially 20 mg once daily in combination w/ pembrolizumab 200 mg IV infusion over 30 min every 3 wk; or 18 mg once daily in combination w/ everolimus 5 mg. Dose modification: 1st dose reduction to: 14 mg once daily; 2nd dose reduction to: 10 mg once daily; 3rd dose reduction to: 8 mg once daily. HCC Patient weighing ≥60 kg Initially 12 mg once daily. Dose modification: 1st dose reduction to: 8 mg once daily; 2nd dose reduction to: 4 mg once daily; 3rd dose reduction to: 4 mg every other day, <60 kg 8 mg once daily. Dose modification: 1st dose reduction to: 4 mg once daily; 2nd dose reduction to: 4 mg every other day; 3rd dose reduction to: Discontinue use. EC Initially 20 mg once daily in combination w/ pembrolizumab 200 mg IV infusion over 30 min every 3 wk. Dose modifica­tion: 1st dose reduction to: 14 mg once daily; 2nd dose reduction to: 10 mg once daily; 3rd dose reduction to: 8 mg once daily. Severe hepatic (Child-Pugh C) & severe renal impairment (CrCl <30 mL/min) TC 14 mg once daily. RCC & EC 10 mg once daily. Moderate hepatic impairment (Child-Pugh B) HCC Initially 8 mg.

May be taken with or without food: Take at the same time each day. Swallow whole w/ water. Alternatively, add cap (w/o breaking or crushing the cap) to 1 tbsp of water/apple juice in a small glass & leave for at least 10 min. Stir mixt for at least 3 min & drink immediately. Rinse glass w/ another 1 tbsp of water/apple juice & drink.

Discontinue use in case of life-threatening reactions eg, Grade 4; event of nephrotic syndrome. Reversible posterior leukoencephalopathy syndrome; serious hemorrhagic events; arterial thromboembolic events; fistula formation & GI perforation; wound healing complications; osteonecrosis of the jaw. Monitor BP after 1 wk of treatment, then every 2 wk for 1st 2 mth & mthly thereafter. Monitor urine protein regularly. Monitor for clinical symptoms or signs of cardiac decompensation. Monitor LFTs prior to, then every 2 wk for 1st 2 mth & mthly thereafter during treatment. Monitor ECG in patients w/ congenital long QT syndrome, CHF, bradyarrhythmias & taking drugs known to prolong QT interval (including class IA & III anti-arrhythmics) & correct electrolyte abnormalities. Monitor blood Ca levels periodically. Monitor thyroid function, T3, T4 & TSH levels prior to & periodically throughout treatment. Perform dental exam & appropriate preventive dentistry prior to & avoid invasive dental procedures during treatment. Concomitant use w/ agents associated w/ osteonecrosis of the jaw eg, bisphosphonates & denosumab. Hepatic & renal impairment (including renal failure). Avoid pregnancy during treatment. Not to be used during lactation. Childn & adolescents <18 yr.

Lymphopenia, thrombocytopenia, leukopenia, neutropenia; cardiac failure, QT interval prolongation; hypothyroidism; abdominal & oral pain, increased amylase & lipase, constipation, diarrhea, dry mouth, dyspepsia, flatulence, GI perforation & fistula, nausea, pancreatitis, stomatitis, vomiting; asthenia, peripheral edema, fatigue, malaise, impaired wound healing; cholecystitis, hepatotoxicity, hepatic failure & encephalopathy; UTI; decreased wt; decreased appetite, dehydration, hypercholesterolemia, hypocalcemia, hypokalemia, hypomagnesemia; arthralgia, back & musculoskeletal pain, myalgia, pain in extremity, osteonecrosis of the jaw; dizziness, dysgeusia, headache, reversible posterior leukoencephalopathy syndrome; insomnia; nephrotic syndrome, proteinuria, renal failure & impairment; cough, dysphonia, pneumothorax, pulmonary embolism; alopecia, hyperkeratosis, palmar-plantar erythrodysesthesia syndrome, rash; arterial thromboembolic events, hemorrhage, HTN, hypotension, aortic dissection.

Decreased AUC & C_max w/ rifampicin.

Targeted Cancer Therapy

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

Rx