GIOTRIF® (afatinib) Dose Modifications

GIOTRIF® (afatinib) dose modification has been shown to reduce the incidence of adverse drug reactions without impacting on drug effectiveness in real-world clinical practice, replicating results seen in clinical trials.1–3

GIOTRIF® (afatinib) dose modification

Giotrif®-Afatinib dose modifications

GIOTRIF® (afatinib) dose modification can be an important strategy to help manage adverse reactions1

  • Initiate therapy at the recommended 40 mg dose

  • Evaluate patients for ARs within 1–2 weeks and periodically thereafter*

  • Pause treatment: 

    • for CTCAE Grade ≥3 ARs, or
    • prolonged** or intolerable CTCAE Grade 2 ARs
  • Resume treatment at 10 mg less per day when AR fully resolves, returns to baseline, or improves
    to Grade 1

A combined analysis of LUX-Lung 3 and 6 found average trough plasma concentrations of GIOTRIF® (afatinib) were higher in the patient population that subsequently received a reduced dose compared with those that remained on a 40 mg dose, with similar trough plasma concentrations achieved following dose modification.

Find out more about how patients benefited from dose modification in real-world clinical practice.

Permanently discontinue GIOTRIF® (afatinib) for:1

  • Severe bullous, blistering or exfoliating conditions; confirmed ILD; severe hepatic impairment and severe or intolerable AR occurring at a dose of 20 mg/day.
  • Find out more about the potential side effects of treatment or learn more about monitoring and management.

Dose escalation

A maximum 50 mg once daily dose may be considered in patients who tolerate a 40 mg once daily starting dose (i.e. absence of diarrhoea, skin rash, stomatitis and other adverse reactions with CTCAE Grade >1) in the first treatment cycle.1

Dose escalation should not be considered in patients with a prior reduction in dose.1

*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. **> 48 hours of diarrhoea and/or > 7 days of rash. If patient cannot tolerate 20 mg/day, permanent discontinuation of GIOTRIF® (afatinib) should be considered.21 days for EGFR M+ NSCLC, 28 days for 2nd-line SqCC.

AR=adverse reaction, CTCAE=National Cancer Institute common terminology criteria for adverse events, EGFR M+=epidermal growth factor receptor mutation positive, ILD=interstitial lung disease, NSCLC=non-small-cell lung cancer, SqCC=squamous cell carcinoma


GIOTRIF® (afatinib), Summary of Product Characteristics, 2018.
Yang JC, et al. Ann Oncol 2016;27(11):2103–2110.
Halmos B, et al. Lung Cancer 2018;127:103–111.