Patients with renal or hepatic impairment

Patients with renal or hepatic impairment

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. 

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.2 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 diarrhea.2

For label information on afatinib use in patients with hepatic impairment, click here.

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References

1

Wiebe S, et al. Eur J Drug Metab Pharmacokinet 2016:1–9.

2

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: January 2021