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DARZALEX® (daratumumab)
Medical Information
DARZALEX + DARZALEX FASPRO - Use in Patients with Hepatic Impairment and Multiple Myeloma
Last Updated: 06/15/2026
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®
References
| 1 | DARZALEX (daratumumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.jnjlabels.com/package-insert/product-monograph/prescribing-information/DARZALEX-pi.pdf |
| 2 |
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