Screening report

Eli Lilly and Company · Package insert of record

JAYPIRCA (PIRTOBRUTINIB)

Not on the NIOSH ListDailyMed (opens the full label on DailyMed in a new tab)
Carcinogenic / genotoxic findings in the label
The label reports carcinogenicity and/or genotoxicity findings — among the criteria NIOSH uses to identify hazardous drugs.
4 / 6NIOSH hazard criteria present in this label
Special handling: not found
Carcinogenicity: present in the label
Developmental: present in the label
Reproductive: not found
Genotoxicity: present in the label
Organ toxicity: present in the label
Carcinogenicity
23 passages in the label

“…[see Dosage and Administration ( 2.2 )] . 5.5 Second Primary Malignancies Second primary malignancies, including non-skin carcinomas, developed in 9% of 704 patients treated with JAYPIRCA m…”

2 more passages

“…( 2.2 )] . 5.5 Second Primary Malignancies Second primary malignancies, including non-skin carcinomas, developed in 9% of 704 patients treated with JAYPIRCA monotherapy across clinical t…”

“…[see Warnings and Precautions ( 5.4 ) ] . Second Primary Malignancies Inform patients that other malignancies have been reported in patients who have been treated with JAYPIRCA, includi…”

Genotoxicity / mutagenicity
2 passages in the label

“…mutagenicity (Ames) assay. Pirtobrutinib was aneugenic in in vitro micronucleus assays using human peripheral blood lymphocytes. Pirtobrutinib was not genotoxic in an in vi…”

1 more passage

“…assay. Pirtobrutinib was aneugenic in in vitro micronucleus assays using human peripheral blood lymphocytes. Pirtobrutinib was not genotoxic in an in vivo rat bone marrow micronuc…”

Developmental / embryo-fetal toxicity
20 passages in the label

“…hepatic function throughout treatment. ( 5.6 ) Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of potential risk to a fetus and to use effect…”

2 more passages

“…confirmation of DILI, discontinue JAYPIRCA. 5.7 Embryo-Fetal Toxicity Based on findings in animals, JAYPIRCA can cause fetal harm when administered to a pregnant woman. In animal r…”

“…rats during the period of organogenesis caused embryo-fetal toxicity including embryo-fetal mortality and malformations at maternal exposures (AUC) approximately 3-times the recom…”

Organ toxicity (verify at low doses)
4 passages in the label

“…advise patients to use sun protection. ( 5.5 ) Hepatotoxicity, Including Drug-Induced Liver Injury: Monitor hepatic function throughout treatment. ( 5.6 ) Embryo-Fetal Toxicity:…”

2 more passages

“…development of second primary malignancies. 5.6 Hepatotoxicity, Including Drug-Induced Liver Injury Hepatotoxicity, including severe, life-threatening, and potentially fatal cases…”

“…Including Drug-Induced Liver Injury Hepatotoxicity, including severe, life-threatening, and potentially fatal cases of drug-induced liver injury (DILI), has occurred i…”

Set aside: found but not counted (7)
NegatedCarcinogenicity: “OCT1, OATP1B1, OATP1B3, or BSEP. 13 13.1 Carcinogenicity studies have not been conducted with pirtobrutinib. Pirtobrutinib was not mutagenic in a bacterial mutagenicity (A”
NegatedGenotoxicity / mutagenicity: “with pirtobrutinib. Pirtobrutinib was not mutagenic in a bacterial mutagenicity (Ames) assay. Pirtobrutinib was aneugenic in in vitro micronucleus assays using human per”
NegatedGenotoxicity / mutagenicity: “Pirtobrutinib was not mutagenic in a bacterial mutagenicity (Ames) assay. Pirtobrutinib was aneugenic in in vitro micronucleus assays using human peripheral blood lymphocytes”
NegatedGenotoxicity / mutagenicity: “blood lymphocytes. Pirtobrutinib was not genotoxic in an in vivo rat bone marrow micronucleus assay at doses up to 2000 mg/kg. Studies to assess the effects of pirtobru”
NegatedGenotoxicity / mutagenicity: “was not genotoxic in an in vivo rat bone marrow micronucleus assay at doses up to 2000 mg/kg. Studies to assess the effects of pirtobrutinib on fertility have not been conducted. I”
NegatedDevelopmental / embryo-fetal toxicity: “from animal studies, JAYPIRCA can cause fetal harm when administered to a pregnant woman. There are no available data on JAYPIRCA use in pregnant women to evaluate for a”
NegatedDevelopmental / embryo-fetal toxicity: “on findings from animal studies, JAYPIRCA can cause fetal harm when administered to a pregnant woman. There are no available data on JAYPIRCA use in pregnant women to evaluate for a”
These matched a hazard term but the text negates the finding, or names a test, a disease or a drug class rather than a finding about this drug. Shown so you can review them yourself.

For information only. This is a count of how many of the six NIOSH hazard-criteria appear in this label after negated and supporting-only statements are set aside. Findings from animal studies count, as NIOSH’s definition counts them, and are tagged “Animal data”. It is not a hazard determination, and the drug-class hint is not counted.