lapatinib
Tyverb · ATC code L01EH01
- Key facts
- Active substance
- lapatinib
- ATC code
- L01EH01
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Tyverb 250 mg film-coated tablets
- Marketing authorisation holder
- Novartis Europharm Limited
- Information as of
- 2026-10-28
Key facts
Lapatinib (Tyverb) is a tyrosine kinase inhibitor of HER2 (ErbB2) used in combination therapy for adults with HER2-overexpressing advanced or metastatic breast cancer.
What it is used for
- HER2-overexpressing breast cancer in adults:
- with capecitabine for advanced or metastatic disease progressing after prior therapy including anthracyclines, taxanes and trastuzumab in the metastatic setting;
- with trastuzumab for hormone receptor-negative metastatic disease that has progressed on prior trastuzumab with chemotherapy;
- with an aromatase inhibitor for postmenopausal women with hormone receptor-positive metastatic disease not currently intended for chemotherapy.
Dosing
- With capecitabine: 1250 mg (five tablets) once daily continuously.
- With trastuzumab: 1000 mg (four tablets) once daily continuously.
- With an aromatase inhibitor: 1500 mg (six tablets) once daily continuously.
- Taken at least one hour before or at least one hour after food, consistently; the daily dose is not divided, and missed doses are not replaced.
- After cardiac events or diarrhoea, treatment may be resumed at a reduced dose (750 mg/day with trastuzumab, 1000 mg/day with capecitabine, 1250 mg/day with an aromatase inhibitor); see the full text for criteria.
- Caution in moderate to severe hepatic impairment and in severe renal impairment.
Contraindications
- Hypersensitivity to the active substance or to any of the excipients.
Important warnings
- Decreases in LVEF have been reported; cardiac function including LVEF should be evaluated before starting.
- Concentration-dependent QTc prolongation; caution in conditions that may prolong QTc such as hypokalaemia or hypomagnesaemia.
- Interstitial lung disease/pneumonitis, which may be severe or fatal; stop for grade 3 or greater pulmonary symptoms.
- Diarrhoea may be severe; dosing is interrupted for grade 3 diarrhoea and permanently stopped for grade 4.
- Treatment should be stopped and not restarted if liver function changes are severe. Lapatinib with chemotherapy has been shown to be less effective than trastuzumab with chemotherapy.
Side effects
- Most common (>25%): diarrhoea, nausea, vomiting and rash; palmar-plantar erythrodysesthesia was also common (>25%) with capecitabine.
- Serious: LVEF decrease, interstitial lung disease, hepatotoxicity.
Interactions
- Strong CYP3A4 inhibitors (e.g. ritonavir, ketoconazole, itraconazole, voriconazole, posaconazole) should be avoided; ketoconazole increased lapatinib exposure approximately 3.6-fold.
- CYP3A4 inducers reduce exposure: carbamazepine decreased lapatinib exposure by approximately 72%.
- Moderate CYP3A4 inhibitors require caution and monitoring.
Pregnancy and breastfeeding
- Should not be used during pregnancy unless clearly necessary; contraception during treatment and for at least 5 days after the last dose.
Summary of the official product information, written with AI on 2026-10-29. 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
This product has no separate US patient information.
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)
- TyverbNovartis Europharm Limited · EMEA/H/C/000795
Source: European Medicines Agency (EMA), product information
Germany
- Lapatinib AlAliud Pharma Gmbh · 1 register entry
- Lapatinib StadaStadapharm Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29
Turkey
- TykerbNOVARTİS SAĞLIK GIDA VE TARIM ÜRÜNLERİ SAN. VE TİC. A.Ş. · 1 register entry
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 13 more European countries
- Cyprus
- Laprem
- Denmark
- Lapatinib Newbury
- France
- Lapatinib Pharos
- Iceland
- Lapatinib Newbury, Tyverb
- Liechtenstein
- Tyverb
- Malta
- Lapatinib Pharos
- Netherlands
- Brastib, Lapatinib Pharos, Lapatinib Stada
- Norway
- Tyverb
- Poland
- Brastib
- Romania
- Lapatinib Stada
- Slovakia
- Lapatinib Stada
- Spain
- Lapatinib Stada
- Sweden
- Lapatinib Newbury
EMA – Article 57 product data (EU/EEA), 2026-10-29
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Other substances in the same group
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Tyverb – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/tyverb-epar-product-information_en.pdf
- EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
Editorial: Medelix editorial team · last updated 2026-10-28 · 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.