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Jaypirca ® (pirtobrutinib) tablets
50 mg,100 mg
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
Can Jaypirca™ (pirtobrutinib) be used in patients with hepatic impairment?
There were no clinically significant differences in the pharmacokinetics of Jaypirca (pirtobrutinib) based on mild, moderate, or severe hepatic impairment.
Pirtobrutinib in Patients with Hepatic Impairment
The pharmacokinetics of pirtobrutinib were characterized in healthy subjects and in patients with cancer.1
There were no clinically significant differences in the pharmacokinetics of pirtobrutinib based on
- mild hepatic impairment (total bilirubin ≤ upper limit of normal [ULN] and aspartate aminotransferase [AST] > ULN, or total bilirubin > 1 to 1.5 times ULN and any AST),
- moderate hepatic impairment (total bilirubin > 1.5 to 3 times ULN and any AST), or
- severe hepatic impairment (total bilirubin > 3 times ULN and any AST).1
Dose Adjustments Due to Hepatic Impairment
No dose adjustment of pirtobrutinib is recommended in patients with
- mild hepatic impairment (total bilirubin ≤ ULN and AST > ULN, or total bilirubin > 1 to 1.5 times ULN and any AST),
- moderate hepatic impairment (total bilirubin > 1.5 to 3 times ULN and any AST), or
- severe hepatic impairment (total bilirubin > 3 times ULN and any AST).1
Enclosed Prescribing Information
Reference
1Jaypirca [package insert]. Indianapolis, IN: Eli Lilly and Company; 2023.
Date of Last Review: December 14, 2022