SUMMARY  

• No clinically significant differences in the pharmacokinetics of daratumumab in patients administered DARZALEX as monotherapy or as combination therapy were observed based on mild [total bilirubin 1 to 1.5 times upper limit of normal (ULN) or aspartate aminotransaminase (AST) >ULN] and moderate (total bilirubin 1.5 to 3 times ULN and any AST) hepatic impairment. The effect of severe (total bilirubin >3 times ULN and any AST) hepatic impairment on daratumumab pharmacokinetics is unknown.¹
• The following population characteristics have no clinically meaningful effect on the pharmacokinetics of daratumumab in patients administered DARZALEX FASPRO as monotherapy or as combination therapy: mild hepatic impairment (total bilirubin 1 to 1.5 times ULN and AST >ULN). The effect of moderate and severe hepatic impairment on daratumumab pharmacokinetics is unknown.²

Literature Search

A literature search of MEDLINE®, Embase®, BIOSIS Previews®, and Derwent Drug File databases (and/or other resources, including internal/external databases) conducted on 19 June 2024 did not identify any relevant citations pertaining to this topic.