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  4. How is Jaypirca™ (pirtobrutinib) dosed?
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Jaypirca ™ (pirtobrutinib) tablets

50 mg,100 mg

Full Prescribing Information

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.

How is Jaypirca™ (pirtobrutinib) dosed?

The recommended dosage of Jaypirca (pirtobrutinib) is 200 mg orally once daily until disease progression or unacceptable toxicity.

US_cFAQ_PIR019_DOSING
US_cFAQ_PIR019_DOSING
en-US

Recommended Dose of Pirtobrutinib

The recommended dosage of pirtobrutinib is 200 mg orally once daily until disease progression or unacceptable toxicity.1

Pirtobrutinib tablets should be 

  • swallowed whole with water, and
  • taken at the same time each day with or without food.1

Dose Modifications

Dose Modifications for Adverse Reactions

Recommended Dose Modifications of Pirtobrutinib for Adverse Reactions Based on a Starting Dosage of 200 mg  describes the recommended dose modifications for adverse reactions to pirtobrutinib.

Recommended Dose Modificationsa of Pirtobrutinib for Adverse Reactions Based on a Starting Dosage of 200 mg1 

If any of the following adverse reactions...

Occur for the...

Then...

And...

  • grade 3 or greater non-hematologic toxicityb
  • 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)b.

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. Asymptomatic 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.

Dose Modifications for Patients With Severe Renal Impairment

For patients with severe renal impairment (estimated glomerular filtration rate [eGFR] 15-29 mL/min), 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 or moderate (eGFR 30-89 mL/min) renal impairment.1

 Dosage Modifications for Concomitant Use with Strong CYP3A Inhibitors

Avoid concomitant use of strong CYP3A inhibitors with pirtobrutinib. If concomitant use of a strong CYP3A inhibitor is unavoidable, reduce the pirtobrutinib dose by 50 mg. If the current dosage is 50 mg once daily, interrupt pirtobrutinib treatment for the duration of strong CYP3A inhibitor use. After discontinuation of a strong CYP3A inhibitor for 5 half-lives, resume the pirtobrutinib dose that was taken prior to initiating the strong CYP3A inhibitor.1

Dosage Modifications for Concomitant Use with CYP3A Inducers

Avoid concomitant use of strong or moderate CYP3A inducers with pirtobrutinib. If concomitant use with moderate CYP3A inducers is unavoidable and the current dosage of pirtobrutinib is 200 mg once daily, increase the dose to 300 mg. If the current dosage is 50 mg or 100 mg once daily, increase the dose by 50 mg.1

Enclosed Prescribing Information

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

Reference

1Jaypirca [package insert]. Indianapolis, IN: Eli Lilly and Company; 2023.

Date of Last Review: January 08, 2023

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