Lenvima

Lenvatinib

Adult patients w/ progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI). Monotherapy in adult patients w/ advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy.

DTC Adult 24 mg once daily, may be reduced to 20 mg once daily, then 14 mg once daily or further reduce to 10 mg once daily. Severe hepatic & renal impairment Initially 14 mg once daily. HCC Patient ≥60 kg 12 mg once daily, <60 kg 8 mg once daily.

May be taken with or without food: Take at the same time each day. Swallow whole w/ water, do not open the cap to avoid repeated exposure. 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.

Hypersensitivity. Breast-feeding.

Control BP & ensure stable antihypertensive therapy dose for at least 1 wk in patients w/ HTN prior to therapy. Monitor BP after 1 wk of treatment then every 2 wk for the 1st 2 mth & mthly thereafter. Regularly monitor urine protein. Discontinue in the event of nephrotic syndrome, GI perforation, fistula or persistent grade 4 diarrhoea occurs. Actively manage GI toxicity to reduce risk of renal impairment or failure. Monitor for clinical symptoms or signs of cardiac decompensation. Posterior reversible encephalopathy syndrome/reversible posterior leucoencephalopathy syndrome. Monitor LFT prior to, then every 2 wk for 1st 2 mth & mthly therafter during treatment. Consider the degree of tumour invasion/infiltration of major blood vessels due to potential risk of severe haemorrhage. Arterial thromboembolism w/in the previous 6 mth. Periodic monitoring of ECG & electrolytes (Mg, K & Ca) in all patients especially for those w/ congenital long QT syndrome, CHF, bradyarrhythmias & taking drugs known to prolong QT interval including class Ia & III antiarrhythmics during treatment. Monitor thyroid function & TSH levels prior to & periodically throughout therapy. Caucasian or Asian patients. May affect ability to drive or operate machinery. Women of childbearing potential must use highly effective contraception while taking & 1 mth after stopping treatment. Do not use during pregnancy. Childn <2 yr, 2 to <18 yr. Elderly ≥75 yr.

UTI; thrombocytopenia; hypocalcaemia, hypokalaemia; decreased wt & appetite; insomnia; dizziness, headache, dysgeusia; haemorrhage, HTN, hypotension; dysphonia; diarrhoea, GI & abdominal pain, vomiting, nausea, oral inflammation & pain, constipation, dyspepsia, dry mouth; palmar-plantar erthrodysaesthesia syndrome, rash, alopecia; back & musculoskeletal pain, arthralgia, myalgia, pain in extremity; proteinuria; fatigue, asthenia, peripheral oedema. Lymphopenia; hypothyroidism, increased blood TSH; dehydration, hypomagnesaemia, hypercholesterolaemia; CVA; MI, cardiac failure, prolonged ECG QT, decreased ejection fraction; pulmonary embolism; anal fistula, flatulence; increased AST, ALT, blood alkaline phosphatase, γ-glutamyltransferase & blood bilirubin, hypoalbuminaemia, abnormal hepatic function; hyperkeratosis; renal failure cases & impairment, increased blood creatinine & urea; malaise.

Decreased exposure to oral CYP3A4/P-gp substrates eg, oral CYP3A4/P-gp substrate eg, astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil or ergot alkaloids (ergotamine, dihydroergotamine). Reduced hormonal contraceptive effectiveness.

Targeted Cancer Therapy

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

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