GIOTRIF®
Dosing and administration
Dosing:
GIOTRIF® (afatinib) allows for the flexibility of individualised dosing.1
The recommended starting dose for GIOTRIF® (afatinib) is 40 mg once daily.1
GIOTRIF® (afatinib) dose modification can be an important strategy to help manage adverse reactions.1
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
Administration:
GIOTRIF® (afatinib) should be taken on an empty stomach.1
- Food should not be taken for at least three hours before and at least one hour after taking a dose
Tablets should be swallowed whole or with water.1
- If this is not possible tablets should be dispersed until broken into small particles, for no longer than 15 minutes, in non-carbonated drinking water and consumed immediately. The glass should be rinsed with
100 ml of water which should also be swallowed
A missed dose should be taken within the same day as soon as the patient remembers.1
- However, if the next dose is due within 8 hours then the missed dose must be skipped
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*
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 Grade1‡
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.
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
Footnotes:
-
* 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.
References:
-
GIOTRIF® (afatinib), Summary of Product Characteristics, 2020.
-
Yang JC, et al. Ann Oncol 2016;27(11):2103–2110.
-
Halmos B, et al. Lung Cancer 2018;127:103–111.
