Giotrif
- Prescription status not stated
- Cancer treatments and immune-system medicines
- Active substance
- Afatinib
- Made by
- Boehringer Ingelheim International GmbH
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
- Giotrif as monotherapy is indicated for the treatment of Epidermal Growth Factor Receptor (EGFR) TKI-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s); locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy.
From the official label · 2026-09-30 · European Medicines Agency
How it works
From the US prescribing label for the same active substance (Afatinib). It describes the substance, not this exact product.
Afatinib covalently binds to the kinase domains of EGFR (ErbB1), HER2 (ErbB2), and HER4 (ErbB4) and irreversibly inhibits tyrosine kinase autophosphorylation, resulting in downregulation of ErbB signaling.
Certain mutations in EGFR, including non-resistant mutations in its kinase domain, can result in increased autophosphorylation of the receptor, leading to receptor activation, sometimes in the absence of ligand binding, and can support cell proliferation in NSCLC.
Approximately 2% of the afatinib dose was metabolized by FMO3; the CYP3A4-dependent N-demethylation was not detected.
Effect of Food A high-fat meal decreased C max by 50% and AUC 0 to INF by 39% relative to the fasted condition [ see Dosage and Administration ( 2.2 ) ].
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-09-03
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United StatesNo exact match for this strength and form
SpainNo exact match for this strength and form
Details
| Made by | Boehringer Ingelheim International GmbH |
|---|---|
| Active substance | Afatinib |
| Used in | Cancer treatments and immune-system medicines |
| Classification | L01XE13 · Cancer treatments and immune-system medicines |
| Authorised on | 2013-09-25 |
| Last updated by the regulator | 2026-05-11 |
| EMA product number | EMEA/H/C/002280 |
Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician
Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).