afatinib
Giotrif · ATC code L01XE13
- Key facts
- Active substance
- afatinib
- Drug class
- ALK inhibitor
- ATC code
- L01XE13
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- GIOTRIF 20 mg film-coated tablets / GIOTRIF 30 mg film-coated tablets / GIOTRIF 40 mg film-coated tablets
- Marketing authorisation holder
- Boehringer Ingelheim International GmbH
- Information as of
- 2026-10-28
Key facts
Afatinib is a tyrosine kinase inhibitor that blocks EGFR signalling. It is used as monotherapy for certain forms of advanced non-small cell lung cancer (NSCLC).
What it is used for
- Adults with locally advanced or metastatic NSCLC with activating EGFR mutation(s) who have not previously received an EGFR tyrosine kinase inhibitor.
- Adults with locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy.
Dosing
- Giotrif (film-coated tablets): recommended dose 40 mg once daily, without food; no food for at least 3 hours before and at least 1 hour after taking it.
- If well tolerated in the first treatment cycle, the dose may be escalated to a maximum of 50 mg/day; no escalation after a prior dose reduction.
- For adverse reactions: interrupt and resume with dose reduction in 10 mg decrements; if 20 mg/day is not tolerated, permanent discontinuation should be considered.
- Renal impairment: no starting-dose adjustment needed; monitor severe impairment; not recommended with eGFR < 15 mL/min/1.73 m² or on dialysis.
- Hepatic impairment: no adjustment for mild or moderate impairment; not recommended in severe (Child-Pugh C) impairment.
- Missed dose: take the same day, unless the next dose is due within 8 hours.
Contraindications
- Hypersensitivity to afatinib or to any of the excipients.
Important warnings
- Diarrhoea, including severe diarrhoea, usually occurs in the first weeks of treatment and can lead to dehydration and renal impairment; proactive anti-diarrhoeal treatment is important.
- Skin reactions, including bullous and exfoliative conditions; rare cases suggestive of Stevens-Johnson syndrome or toxic epidermal necrolysis.
- Interstitial lung disease: interrupt treatment for acute or worsening respiratory symptoms; discontinue if confirmed.
- Hepatic failure, including fatal cases, has been reported; periodic liver function testing is recommended in patients with pre-existing liver disease.
- Keratitis: eye symptoms should be referred promptly to an ophthalmologist; contact lens use is a risk factor.
- EGFR mutation status must be established with a validated method before starting treatment.
Side effects
- Most frequent: diarrhoea, skin reactions (rash, dermatitis acneiform, dry skin, pruritus), stomatitis and paronychia.
- Others: decreased appetite, nausea, vomiting, epistaxis, conjunctivitis, increased liver enzymes.
- Serious: interstitial lung disease, keratitis, pancreatitis, gastrointestinal perforation, renal failure.
Interactions
- Strong P-gp inhibitors (e.g. ritonavir, ciclosporin, ketoconazole, itraconazole, verapamil) can increase afatinib exposure and should be given staggered, as far apart as possible from the afatinib dose.
- Strong P-gp inducers (e.g. rifampicin) may decrease afatinib exposure.
Pregnancy and breastfeeding
- Women of childbearing potential should use adequate contraception during treatment and for at least 1 month after the last dose; EGFR-targeting medicines have the potential to cause foetal harm.
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)
- GiotrifBoehringer Ingelheim International GmbH · EMEA/H/C/002280
Source: European Medicines Agency (EMA), product information
Turkey
- GiotrifBOEHRİNGER INGELHEİM İLAÇ TİC. A.Ş. · 3 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 8 more European countries
- Cyprus
- Afatinib Afatinib, Afatinib Sapiens
- Greece
- Webrix
- Iceland
- Giotrif
- Latvia
- Afatinib
- Liechtenstein
- Giotrif
- Malta
- Afatinib Lotus
- Norway
- Giotrif
- Sweden
- Afatinib Lotus, Webrix
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. Giotrif – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/giotrif-epar-product-information_en.pdf
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
- Wikidata (CC0): ATC L01XE.
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.