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Patients with renal impairment
In an open-label, single-dose study that included patients with moderate (n=8) or severe (n=8) renal impairment, plasma protein binding of afatinib* was similar to that in matched healthy controls. Moderate to severe renal impairment had a minor influence on the pharmacokinetics of afatinib, with a trend towards increased exposure in patients with severe renal impairment. All adverse events (AEs) in this study were Common Terminology Criteria Adverse Events Grade 1.1 The recommended dose of 40 mg was considered to be safe and equally well tolerated in these patients. Two case reports on afatinib in patients undergoing haemodialysis for chronic renal failure indicate that patients could be safely treated with 30 mg afatinib.2,3 Other case reports also suggest that afatinib is well tolerated in patients undergoing haemodialysis,4 especially when provided with dose reductions, and in an elderly patient with chronic kidney disease.5
For label information on afatinib use in patients with renal impairment, click here.
Patients with hepatic impairment
In an open-label, single-dose study that included patients with mild (n=8) or moderate (n=8) hepatic impairment, impaired hepatic function had no effect on plasma protein binding of afatinib.6 Hepatic impairment had no clinically relevant effect on the absorption, distribution or elimination of afatinib. AEs were reported in five patients with hepatic impairment and in one healthy control patient. Three patients with mild hepatic impairment had AEs that were considered to be treatment-related: Grade 3 lipase elevation, likely caused by cholecystolithiasis; Grade 2 headache and nausea; and Grade 1 diarrhoea.6
For label information on afatinib use in patients with hepatic impairment, click here.
For further information on special populations, such as renal impaired patients, polymedicated patients and patients with brain metastases, please visit the article library where you can search an extensive list of publications that can be sorted by patient population.
Wiebe S, et al. Eur J Drug Metab Pharmacokinet 2016:1–9.
Yamaguchi T, et al. Cancer Treatment Commun 2015;4:169–71.
Bersanelli M, et al. Anticancer Res 2014;34(6):3185–8.
Imai H, et al. Cancer Chemother Pharmacol 2017;79(1):209–213.
Okauchi S, et al. Eur Geriatr Med 2017;8(2):104.
Schnell D, et al. Cancer Chemother Pharmacol 2014;74(2):267–75.
*Afatinib is approved in more than 80 markets, including the EU, Japan, Taiwan and Canada under the brand name GIOTRIF®, in the US under the brand name GILOTRIF® and in India under the brand name Xovoltib®; for the full list, please click here. Registration conditions differ internationally; please refer to locally approved prescribing information.
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Last updated: October 2018
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