lenvatinib
Kisplyx, Lenvima · ATC code L01XE29
Brand names: Kisplyx, Lenvima, Lenvatinib Accord, Lenvatinib Rcc Sandoz, Lenvatinib Rcc Teva B.V, Lenvatinib Rcc Teva B.V., Lenvatinib Sandoz, Lenvatinib Stada®, Lenvatinib Teva, Lenvatinib Viatris, Lenvatinib Hexal, Lenvatinib Ratiopharm, Lenvatinib-Rcc Ratiopharm, Syltezib
- Key facts
- Active substance
- lenvatinib
- Drug class
- ALK inhibitor
- ATC code
- L01XE29
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Kisplyx 4 mg hard capsules / Kisplyx 10 mg hard capsules · LENVIMA 4 mg hard capsules / LENVIMA 10 mg hard capsules
- Marketing authorisation holder
- Eisai GmbH
- Information as of
- 2026-10-27
Key facts
Lenvatinib is a multikinase inhibitor. As Kisplyx it is used in advanced renal cell carcinoma; as Lenvima in thyroid, hepatocellular and endometrial carcinoma.
What it is used for
- Kisplyx: advanced renal cell carcinoma – first-line with pembrolizumab, or with everolimus after one prior VEGF-targeted therapy
- Lenvima: progressive, radioactive-iodine-refractory differentiated thyroid carcinoma (monotherapy)
- Lenvima: advanced or unresectable hepatocellular carcinoma with no prior systemic therapy (monotherapy)
- Lenvima: advanced or recurrent endometrial carcinoma after platinum-containing therapy, with pembrolizumab
Dosing
- Kisplyx with pembrolizumab: 20 mg once daily
- Kisplyx with everolimus: 18 mg once daily plus everolimus 5 mg daily
- Lenvima in thyroid carcinoma: 24 mg once daily; reduction steps 20 mg, 14 mg, 10 mg
- Lenvima in HCC: 8 mg daily (< 60 kg) or 12 mg daily (≥ 60 kg)
- Lenvima in endometrial carcinoma: see full text for dosing
- Skip a missed dose if it cannot be taken within 12 hours; modify dose by toxicity
Contraindications
- Hypersensitivity to the active substance or any excipient
- Breast-feeding
Important warnings
- Hypertension, usually early; control blood pressure before starting; serious complications including aortic dissection reported
- Proteinuria and renal failure; treat gastrointestinal toxicity actively
- Arterial thromboembolism, cardiac failure, haemorrhage, hepatic failure, PRES
- Severe reactions require interruption and resumption at a reduced dose
Side effects
- Very frequent: hypertension, diarrhoea, decreased appetite, weight loss, fatigue, nausea, proteinuria, stomatitis
- Also frequent: vomiting, dysphonia, headache, palmar-plantar erythrodysaesthesia, hypothyroidism (with pembrolizumab)
- Serious: renal failure, arterial thromboembolism, cardiac failure, intracranial tumour haemorrhage, hepatic failure
Interactions
- No significant interaction expected with CYP3A4/P-gp substrates
- Unknown whether hormonal contraceptives are less effective – add a barrier method
Pregnancy and breastfeeding
- Highly effective contraception during and for at least one month after treatment; use in pregnancy only if clearly necessary
- Breast-feeding is contraindicated
Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
Source: European Medicines Agency (EMA), product information
Austria
- Lenvatinib AccordAccord Healthcare B.V. · 1 register entry
- Lenvatinib Rcc SandozSandoz Gmbh · 1 register entry
- Lenvatinib Rcc Teva B.VRatiopharm Arzneimittel Vertriebs-Gmbh · 1 register entry
- Lenvatinib Rcc Teva B.V.Ratiopharm Arzneimittel Vertriebs-Gmbh · 1 register entry
- Lenvatinib SandozSandoz Gmbh · 1 register entry
- Lenvatinib Stada®Stadapharm Gmbh · 1 register entry
- Lenvatinib TevaRatiopharm Arzneimittel Vertriebs-Gmbh · 1 register entry
- Lenvatinib ViatrisViatris Limited · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Germany
- Lenvatinib AccordAccord Healthcare B.V. · 1 register entry
- Lenvatinib HexalHexal Ag · 2 register entries
- Lenvatinib RatiopharmRatiopharm Gmbh · 1 register entry
- Lenvatinib-Rcc RatiopharmRatiopharm Gmbh · 1 register entry
- SyltezibAccord Healthcare B.V. · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Brand names in 27 more European countries
- Belgium
- Ixedafin, Lenvatinib Accord, Pelipton
- Bulgaria
- Ленватиниб Виатрис
- Croatia
- Lenvatinib Remedica
- Cyprus
- Lenvatinib Remedica
- Czechia
- Lenvatinib Accord, Lenvatinib Sandoz, Lenvatinib Teva, Lenvatinib Viatris, Syltezib
- Denmark
- Lenvatinib Accord, Lenvatinib Sandoz, Lenvatinib Stada, Lenvatinib Teva, Lenvatinib Viatris
- Estonia
- Lenvatinib Remedica, Lenvatinib Sandoz, Lenvatinib Stada
- Finland
- Ixedafin, Lenvatinib, Palarccio, Pelipton
- France
- Ixedafin, Lenvatinib Accord, Lenvatinib Biogaran, Lenvatinib Gnr, Lenvatinib Sandoz, Lenvatinib Teva, Lenvatinib Viatris, Pelipton
- Greece
- Kynvalib, Lenvatinib Elpen, Lenvatinib Sandoz, Lenvatinib Teva
- Hungary
- Lenvatinib Stada
- Iceland
- Kisplyx, Lenvima
- Ireland
- Lenvatinib Accord, Lenvatinib Stada, Lenvatinib Viatris
- Italy
- Lenvatinib Accord, Lenvatinib Sandoz, Lenvatinib Teva
- Latvia
- Lenvatinib Sandoz, Lenvatinib Stada
- Liechtenstein
- Kisplyx, Lenvima
- Lithuania
- Lenvatinib Sandoz, Lenvatinib Stada
- Luxembourg
- Ixedafin, Lenvatinib Olpha, Pelipton, Xyvora
- Malta
- Lenvatinib Remedica, Lenvatinib Stada
- Netherlands
- Lenvatinib, Palarccio, Syltezib, Xyvora
- Norway
- Kisplyx, Lenvatinib Accord, Lenvatinib Sandoz, Lenvatinib Stada, Lenvatinib Teva, Lenvatinib Viatris, Lenvima, Palarccio
- Portugal
- Lenvatinib Accord, Lenvatinib Sandoz, Lenvatinib Viatris
- Romania
- Lenvatinib Stada
- Slovakia
- Lenvatinib Pharmevid
- Slovenia
- 10, Lenvatinib Sandoz
- Spain
- Lenvatinib Accord, Lenvatinib Sandoz, Lenvatinib Stada
- Sweden
- Lenvatinib Accord, Lenvatinib Avansor, Lenvatinib Mylan, Lenvatinib Sandoz, Lenvatinib Stada, Lenvatinib Viatris, Palarccio
EMA – Article 57 product data (EU/EEA), 2026-10-28
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
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Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Kisplyx – EPAR, Product Information. 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/kisplyx-epar-product-information_en.pdf
- European Medicines Agency. Lenvima – EPAR, Product Information. 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/lenvima-epar-product-information_en.pdf
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- Wikidata (CC0): ATC L01XE.
Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.