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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.

Are there any dose modifications for hematologic and non-hematologic adverse events?

Dose modifications are recommended for low absolute neutrophil, low platelet counts, and any grade 3 non-hematologic toxicity.

US_cFAQ_PIR077_DOSE_MODIFICATIONS_AE

en-US

Dose Modifications for Hematologic Adverse Events

Monitor complete blood counts regularly during treatment. Based on severity, reduce dose, temporarily withhold, or permanently discontinue treatment with pirtobrutinib.1

Dose modifications are recommended for

absolute neutrophil count
- < 1 to 0.5 x 10⁹/L with fever and/or infection or
- < 0.5 x 10⁹/L lasting 7 or more days
platelet count
- < 50 to 25 x 10⁹/L with bleeding or
- < 25 x 10⁹/L.1

Recommended Dose Modifications of Pirtobrutinib for Hematologic Adverse Reactions Based on a Starting Dosage of 200 mg summarizes the recommended dose modifications for hematologic adverse events.

Recommended Dose Modificationsa of Pirtobrutinib for Hematologic Adverse Reactions Based on a Starting Dosage of 200 mg1
If any of the following adverse reactions...	Occur for the...	Then...	And...
absolute neutrophil count < 1 to 0.5 x 10⁹/L with fever and/or infection absolute neutrophil count < 0.5 x 10⁹/L lasting 7 or more days platelet count < 50 to 25 x 10⁹/L with bleeding platelet count < 25 x 10⁹/L	first time	interrupt pirtobrutinib until recovery to grade 1 or baseline	restart at original dose level (200 mg daily).
	second time		restart at 100 mg daily.
	third time		restart at 50 mg daily.
	fourth time	discontinue pirtobrutinib	do not restart.

aDose modification is not recommended for asymptomatic lymphocytosis.

Dose Modifications for Non-Hematologic Adverse Events

Dose modifications are recommended for any grade 3 non-hematologic toxicity.1

Recommended Dose Modifications of Pirtobrutinib for Non-Hematologic Adverse Reactions Based on a Starting Dosage of 200 mg summarizes the recommended dose modifications for non-hematologic adverse events.

Recommended Dose Modificationsa of Pirtobrutinib for Non-Hematologic Adverse Reactions Based on a Starting Dosage of 200 mg 1
If the following adverse reaction...	Occurs for the...	Then...	And...
Any grade 3 or greater non-hematologic toxicityb	first time	interrupt pirtobrutinib until recovery to grade 1 or baseline	restart at original dose level (200 mg daily)b.
	second time		restart at 100 mg daily.
	third time		restart at 50 mg daily.
	fourth time	discontinue pirtobrutinib	do not restart.

aAsymptomatic lipase increase may not necessarily warrant dose modification.

bEvaluate the benefit-risk before resuming treatment at the same dose for a grade 4 non-hematological toxicity.

Enclosed Prescribing Information

JAYPIRCA® (pirtobrutinib) tablets, for oral use, Lilly

Reference

1Jaypirca [package insert]. Indianapolis, IN: Eli Lilly and Company; 2024.

Date of Last Review: December 12, 2022

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Jaypirca ® (pirtobrutinib) tablets