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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 renal impairment?
A population pharmacokinetic analysis showed exposure of Jaypirca (pirtobrutinib) had no clinically meaningful effect in patients with mild or moderate renal impairment.
Pirtobrutinib in Patients with Renal Impairment
The pharmacokinetics of pirtobrutinib were characterized in healthy subjects and in patients with cancer.1
Following a single 200 mg oral dose, the area under the curve (AUC) of pirtobrutinib in subjects with severe renal impairment (estimated glomerular filtration rate [eGFR] 15-29 mL/min) increased by 62% and mean unbound AUC increased by 68% compared to healthy subjects with normal renal function. There were no clinically significant differences in the pharmacokinetics of pirtobrutinib in subjects with mild (eGFR 60-89 mL/min) or moderate renal impairment (eGFR 30-59 mL/min).1
The effect of renal impairment requiring dialysis on the pharmacokinetics of pirtobrutinib is unknown.1
Dose Adjustments Due to Renal Impairment
Severe renal impairment (eGFR 15-29 mL/min) increases pirtobrutinib exposure. Reduce the pirtobrutinib dosage in patients with severe renal impairment. Reduce the pirtobrutinib dose to 100mg once daily if the current dose is 200mg once daily, otherwise reduce the dose by 50mg. If the current dosage is 50mg once daily, discontinue pirtobrutinib.1
No dosage adjustment of pirtobrutinib is recommended in patients with mild (60-89 mL/min) or moderate (30-59 mL/min) renal impairment.1
Enclosed Prescribing Information
1Jaypirca [package insert]. Indianapolis, IN: Eli Lilly and Company; 2023.
Date of Last Review: December 14, 2022