GIOTRIF® (afatinib) dose modification
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 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*
- 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
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.