Concise Prescribing Info
Unresectable thyroid cancer. Advanced renal cell carcinoma (RCC) following 1 prior antiangiogenic therapy in combination w/ everolimus. 1st-line treatment of unresectable hepatocellular carcinoma (HCC). In combination w/ pembrolizumab, for the treatment of patients w/ advanced endometrial carcinoma 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
Adult Individualized dosage. Thyroid cancer 24 mg once daily. Dose modifications: 1st dose reduction: 20 mg once daily; 2nd dose reduction: 14 mg once daily; 3rd dose reduction: 10 mg once daily. Renal cell carcinoma 18 mg in combination w/ everolimus 5 mg once daily at the same time each day. Dose modifications: 1st dose reduction: 14 mg once daily; 2nd dose reduction: 10 mg once daily; 3rd dose reduction: 8 mg once daily. Hepatocellular carcinoma Patient weighing >60 kg 12 mg once daily; <60 kg 8 mg once daily. Dose modifications: 1st occurrence: Patient weighing >60 kg 8 mg once daily, <60 kg 4 mg once daily. 2nd occurrence: Patient weighing >60 kg 4 mg once daily, <60 kg 4 mg every other day. 3rd occurrence: Patient weighing >60 kg 4 mg every other day, <60 kg Discontinue use. Endometrial carcinoma 20 mg once daily in combination w/ pembrolizumab 200 mg IV infusion over 30 min every 3 wk. Dose modifica¬≠tions: 1st dose reduction: 14 mg once daily; 2nd dose reduction: 10 mg once daily; 3rd dose reduction: 8 mg once daily. Severe hepatic (Child-Pugh C) & severe renal impairment (CrCl <30 mL/min) Once daily, 14 mg for thyroid cancer, 10 mg of lenvatinib plus everolimus 5 mg for RCC & 10 mg of lenvatinib w/ the dose of pembrolizumab as recommended in its prescribing information for endometrial cancer.
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.
Hypersensitivity. Women suspected of being pregnant. Pregnancy.
Special Precautions
Patients w/ differentiated thyroid cancer w/ no history of radioactive iodine treatment. HTN; monitor BP after 1 wk of treatment then every 2 wk for the 1st 2 mth & mthly while on treatment. Proteinuria; monitor urine protein regularly; withhold, adjust or discontinue if urine dipstick proteinuria ≥2+ is detected. Actively manage GI toxicity in order to reduce the risk of development of renal impairment or failure. Cardiac failure & decreased left ventricular ejection fraction; reversible posterior leukoencephalopathy syndrome; hepatic failure & acute hepatitis; serious hemorrhagic events; withhold treatment for the development of Grade 3 hemorrhage until resolved to Grade 0 to 1; discontinue in case of Grade 4 hemorrhage. Arterial thromboembolic events. Discontinue in patients who develop GI perforation or fistula formation. Hypocalcaemia; hypothyroidism. Monitor blood Ca levels periodically. Monitor ECG in patients w/ congenital long QT syndrome, CHF, bradyarrhythmias & drugs known to prolong QT interval. Monitor & correct electrolyte abnormalities. Consider temporary interruption of therapy in patients undergoing major surgical procedures. Women of childbearing potential. Avoid pregnancy. Not to be used during lactation. Childn & adolescents <18 yr. HCC: Severe hepatic (Child-Pugh C). Renal impairment (including renal failure).
Adverse Reactions
Lymphopenia, thrombocytopenia, leukopenia, neutropenia; cardiac failure, QT interval prolongation; hypothyroidism; abdominal pain, amylase increased, constipation, diarrhea, dry mouth, dyspepsia, flatulence, GI perforation & fistula, increased lipase, nausea, oral pain, pancreatitis, stomatitis, vomiting; asthenia, peripheral edema, fatigue, malaise, impaired healing; cholecystitis, hepatotoxicity, hepatic failure, hepatic encephalopathy; UTI; wt decreased; decreased appetite, dehydration, hypercholesterolemia, hypocalcemia, hypokalemia, hypomagnesemia; arthralgia, back pain, musculoskeletal pain, myalgia, pain in extremity; 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.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01EX08 - lenvatinib ; Belongs to the class of other protein kinase inhibitors. Used in the treatment of cancer.
Lenvima cap 10 mg
Lenvima cap 4 mg
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