Active Ingredient: Afatinib
Afatinib 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).
For this indication, competent medicine agencies globally authorize below treatments:
Oral
40 - 50 mg
From 40 To 50 mg once every day
The recommended dose is 40 mg once daily.
This medicinal products hould be taken without food. Food should not be consumed for at least 3 hours before and at least 1 hour after taking this medicinal product.
Afatinib treatment should be continued until disease progression or until no longer tolerated by the patient (see table below).
A dose escalation to a maximum of 50 mg/day may be considered in patients who tolerate a 40 mg/day starting dose (i.e. absence of diarrhoea, skin rash, stomatitis, and other adverse reactions with CTCAE Grade >1) in the first cycle of treatment (21 days for EGFR mutation positive NSCLC and 28 days for squamous NSCLC). The dose should not be escalated in any patients with a prior dose reduction. The maximum daily dose is 50 mg.
Symptomatic adverse reactions (e.g. severe/persistent diarrhoea or skin related adverse reactions) may be successfully managed by treatment interruption and dose reductions or treatment discontinuation of afatinib as outlined in the following table.
Dose adjustment information for adverse reactions:
| CTCAEa Adverse reactions | Recommended dosing | |
|---|---|---|
| Grade 1 or Grade 2 | No interruptionb | No dose adjustment |
| Grade 2 (prolongedc or intolerable) or Grade >3 | Interrupt until Grade 0/1 b | Resume with dose reduction by 10 mg decrementsd |
a NCI Common Terminology Criteria for Adverse Events
b In case of diarrhoea, anti-diarrhoeal medicinal products (e.g. loperamide) should be taken immediately and continued for persistent diarrhoea until loose bowel movements cease.
c >48 hours of diarrhoea and/or >7 days of rash
d If patient cannot tolerate 20 mg/day, permanent discontinuation of afatinib should be considered
Interstitial Lung Disease (ILD) should be considered if a patient develops acute or worsening of respiratory symptoms in which case treatment should be interrupted pending evaluation. If ILD is diagnosed, afatinib should be discontinued and appropriate treatment initiated as necessary.
If a dose is missed, it should be taken within the same day as soon as the patient remembers. However, if the next scheduled dose is due within 8 hours then the missed dose must be skipped.
This medicinal products hould be taken without food. Food should not be consumed for at least 3 hours before and at least 1 hour after taking this medicinal product.
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