You are now leaving the Lilly Medical website
The link you clicked on will take you to a site maintained by a third party, which is solely responsible for its content. Lilly USA, LLC does not control, influence, or endorse this site, and the opinions, claims, or comments expressed on this site should not be attributed to Lilly USA, LLC. Lilly USA, LLC is not responsible for the privacy policy of any third-party websites. We encourage you to read the privacy policy of every website you visit.
Click "Continue" to proceed or "Return" to return to Lilly Medical
If you wish to report an adverse event or product complaint, please call 1-800-LILLYRX (1-800-545-5979)
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 pregnant women or in women who are breastfeeding?
Pirtobrutinib is not advised during pregnancy due to potential fetal harm. Breastfeeding women are advised not to breastfeed during treatment and for 1 week after the last treatment dose.
Use of Pirtobrutinib During Pregnancy
Advise pregnant women and females of reproductive potential that pirtobrutinib can cause fetal harm when administered to pregnant women.1
Women of reproductive potential are advised to
- inform their healthcare provider of a known or suspected pregnancy
- use an effective contraceptive during treatment with pirtobrutinib, and
- use an effective contraceptive for 1 week after the last dose of pirtobrutinib.1
The pregnancy status in women of reproductive potential should be verified prior to initiating treatment with pirtobrutinib.1
Embryo-Fetal Toxicity
Currently, no data are available on the use of pirtobrutinib in pregnant women to evaluate for a drug-associated risk. Based on findings in animals, pirtobrutinib can cause fetal harm when administered to a pregnant woman.1
In animal reproduction studies, administration of pirtobrutinib to pregnant rats during the period of organogenesis resulted in adverse developmental outcomes at maternal exposures approximately 3-times those in patients at the recommended daily dose of 200 mg. The adverse developmental outcomes included
- structural abnormalities
- altered fetal growth, and
- embryo-fetal mortality.1
Animal Data
In an embryo-fetal development study in rats, pregnant animals were administered oral doses of pirtobrutinib at up to 500 mg/kg twice daily during the period of organogenesis. Doses ≥375 mg/kg twice daily caused
- decreased fetal body weights, and
- increased incidence of malformations and variations in the
- urinary tract (including absent or abnormal ureters and kidneys)
- reproductive tract (malpositioned ovaries and misshapen uterus), and
- bone (misshapen sternebrae).1
At 500 mg/kg twice daily, total resorption was observed.1
At 375 mg/kg twice daily in rats, the maternal systemic exposures as measured by area under the curve (AUC) were approximately 3 times the human exposure at 200 mg once daily.1
Use of Pirtobrutinib During Lactation
Advise breastfeeding women not to breastfeed during their treatment with pirtobrutinib and for one week after the last dose of pirtobrutinib due to the potential for serious adverse reactions from pirtobrutinib in the breastfed child.1
Currently, no data are available for pirtobrutinib regarding its
- presence in human milk
- effects on the breastfed child, or
- effect on milk production.1
Use of Contraception During Pirtobrutinib Treatment
Female patients of reproductive potential are advised to use effective contraception during treatment with pirtobrutinib and for one week after the last dose of pirtobrutinib.1
No specific recommendations are available regarding the use of contraception for male patients during pirtobrutinib treatment or after treatment is completed.
Enclosed Prescribing Information
Reference
1Jaypirca [package insert]. Indianapolis, IN: Eli Lilly and Company; 2026.
Date of Last Review: May 13, 2026