Finished product reference
Lenvatinib
Capsule · Oral · 10 mg
- List code
- 50758
- Salt form
- Mesilate
- Pharmacologic class
- Antineoplastic: multi-targeted receptor tyrosine kinase inhibitor
What it is and how it works
Lenvatinib inhibits the kinase activity of VEGF receptors 1–3, FGF receptors 1–4, PDGFR-alpha, KIT and RET. Inhibition of these pathways reduces tumour angiogenesis and tumour cell proliferation.
Indications
Radioactive iodine-refractory differentiated thyroid carcinoma; unresectable hepatocellular carcinoma (first line); advanced renal cell carcinoma (with everolimus or pembrolizumab); advanced endometrial carcinoma after platinum therapy (with pembrolizumab).
Dosage and administration (summary)
Oral once daily, dose depending on indication: 24 mg (thyroid cancer); 8 mg if under 60 kg or 12 mg if 60 kg or more (hepatocellular carcinoma); 18 mg with everolimus or 20 mg with pembrolizumab (renal cell or endometrial carcinoma). Dose interruption and reduction are used to manage toxicity.
Contraindications
Hypersensitivity to lenvatinib or excipients; breast-feeding.
Warnings and precautions
Hypertension should be controlled before and monitored during treatment; proteinuria, renal failure, hepatotoxicity, cardiac dysfunction, arterial thromboembolism, haemorrhage, gastrointestinal perforation and fistula, QT prolongation, hypocalcaemia and posterior reversible encephalopathy syndrome may occur. Withhold before major surgery because of impaired wound healing. Monitor blood pressure, urine protein, liver and thyroid function and electrolytes regularly.
Pregnancy
Should not be used in pregnancy; effective contraception is required during treatment and for at least one month afterwards.
Storage and supply
Store below 25 °C in the original package to protect from moisture.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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