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LENVANIX

LENVATINIB · by HIMMEL

ANTINEOPLASTICS Multireceptor Tyrosine Kinase Inhibitor HIMMEL

Composition

Cap 4 mg/10 mg: Lenvatinib 4 mg/10 mg

Indications & Dosage

Advanced renal cell carcinoma following one prior vascular endothelial growth factor-targeted therapy in combination with everolimus (specialist use only): Adult: 18 mg once daily, dose should be taken at the same time every day, consult product literature. Differentiated thyroid carcinoma (specialist use only): Adult: 24 mg once daily, dose should be taken at the same time every day, consult product literature. Hepatocellular carcinoma (specialist use only): Adult (body-weight up to 60 kg): 8 mg once daily, Adult (body-weight 60 kg and above): 12 mg once daily, dose should be taken at the same time every day, consult product literature.

Contraindications

Fistulae

Precautions

Arterial thromboembolism within the previous 6 months, elderly (75 years and over), hypertension, monitoring of blood pressure, impaired wound healing (interrupt temporarily), risk factors for aneurysm or artery dissection, women of child-bearing potential should use highly effective contraception during treatment and for 1 month after the last dose, caution in severe hepatic impairment, dose reduction to 10 mg once daily, avoid in severe hepatic impairment, dose adjustments when used for Differentiated thyroid carcinoma advised to be 14 mg once daily. Avoid in end-stage renal disease, reduce dose to 10 mg once daily in severe impairment, dose adjustments when used for Differentiated thyroid carcinoma advised to be 14 mg once daily. Monitor for signs and symptoms of cardiac decompensation (adjust dose), Monitor liver function before treatment, every 2 weeks and monthly later on, monitor urine protein regularly. Monitor ECG and electrolytes before and periodically during treatment (calcium levels should be monitored monthly), correct electrolyte abnormalities prior to treatment; monitor thyroid function before and regularly during treatment.

Pregnancy

Avoid unless potential benefit outweighs risk

Lactation

Avoid

Side Effects

Alopecia, neutropenia, heart failure, asthenia, cerebrovascular insufficiency, arthralgia, decreased appetite, decreased leucocytes, cholecystitis, constipation, dehydration, diarrhoea, dizziness, dry mouth, dysphonia, electrolyte imbalance, embolism and thrombosis, encephalopathy, GI disorders, headache, hepatic coma, hepatic disorders, hyperbilirubinaemia, hypercholesterolaemia, hypertension, hypoalbuminaemia, hypotension, hypothyroidism, insomnia, malaise, mucositis, myalgia, myocardial infarction, nausea, oral disorders, oropharyngeal complaints, pain, peripheral oedema, proteinuria, QT interval prolongation, renal impairment, renal tubular necrosis, skin reactions, thrombocytopenia, vomiting, weight decreased, healing impaired, nephrotic syndrome, pancreatitis, paresis, pneumothorax, splenic infarction. Rare: Aneurysm, artery dissection, cardiac disorder, cardiogenic shock, fistula.