Screening report

Janssen Biotech, Inc. · Package insert of record

AKEEGA (NIRAPARIB TOSYLATE MONOHYDRATE AND ABIRATERONE ACETATE)

NIOSH Table 2DailyMed (opens the full label on DailyMed in a new tab)
On the NIOSH List — Table 2
This drug appears on the NIOSH List of Hazardous Drugs, 2024 (Table 2).
5 / 6NIOSH hazard criteria present in this label
Special handling: not found
Carcinogenicity: present in the label
Developmental: present in the label
Reproductive: present in the label
Genotoxicity: present in the label
Organ toxicity: present in the label
Carcinogenicity
11 passages in the label

“…AND PRECAUTIONS Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML) : MDS/AML, including a case with fatal outcome, has been observed in patients treated with AKEEGA. Monitor pa…”

2 more passages

“…5.9 , 8.1 , 8.3 ) 5.1 Myelodysplastic Syndrome/Acute Myeloid Leukemia AKEEGA may cause myelodysplastic syndrome/acute myeloid leukemia (MDS/AML). In the individual AMPLITUDE and MAGNITUDE s…”

“…AKEEGA may cause myelodysplastic syndrome/acute myeloid leukemia (MDS/AML). In the individual AMPLITUDE and MAGNITUDE studies, MDS or AML, including cases with fatal outcomes, were rep…”

Genotoxicity / mutagenicity
8 passages in the label

“…and/or embryo-fetal death since niraparib is genotoxic and targets actively dividing cells in animals and patients (e.g., bone marrow) [see Warnings and Precautions (5.2) a…”

2 more passages

Animal study“…) . Data Animal Data Niraparib Niraparib is genotoxic and targets actively dividing cells. Animal developmental and reproductive toxicology studies were not conducted with…”

Animal study“…been conducted with niraparib. Niraparib was clastogenic in an in vitro mammalian chromosomal aberration assay and in an in vivo rat bone marrow micronucleus assay. This clas…”

Developmental / embryo-fetal toxicity
17 passages in the label

“…(12.1) ] . Niraparib has the potential to cause teratogenicity and/or embryo-fetal death since niraparib is genotoxic and targets actively dividing cells in animals and patients…”

2 more passages

“…AKEEGA if PRES is confirmed. ( 5.8 ) Embryo-Fetal Toxicity: AKEEGA can cause fetal harm. Advise males with female partners of reproductive potential to use effective con…”

“…the potential to cause teratogenicity and/or embryo-fetal death since niraparib is genotoxic and targets actively dividing cells in animals and patients (e.g., bone marrow) [see…”

Reproductive / fertility toxicity
5 passages in the label

“…Advise male patients that AKEEGA may impair fertility [see (8.3) ]. Product of France Manufactured for: Janssen Biotech, Inc. Horsham, PA 19044, USA For patent information…”

2 more passages

“…and How Supplied/Storage and Handling (16) ] . Infertility Advise male patients that AKEEGA may impair fertility [see (8.3) ]. Product of France Manufactured for: Janssen Biote…”

Animal study“…Infertility Based on animal studies, AKEEGA may impair fertility in males of reproductive potential [see (13.1) ] . 8.4 Pediatric Use Safety and effectiveness of AKEEGA in pediatric…”

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

“…dose of AKEEGA 100 mg/1,000 mg once daily. Hepatotoxicity [see Warnings and Precautions (5.4) ] ALT and/or AST greater than 5 × ULN or total bilirubin greater than 3 × ULN Wi…”

2 more passages

“…and during treatment with AKEEGA. ( 5.3 ) Hepatotoxicity: Can be severe and fatal. Monitor liver function and modify, interrupt, or discontinue treatment as recommended. ( 2…”

“…were excluded from AMPLITUDE and MAGNITUDE. 5.4 Hepatotoxicity AKEEGA may cause hepatotoxicity. Hepatotoxicity in patients receiving abiraterone acetate, a component of AKEEGA, ha…”

Set aside: found but not counted (12)
Supporting onlyManufacturer special-handling information: “vitro studies have shown that niraparib-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complexes resulting in DNA dam”
NegatedCarcinogenicity: “inhibitors of OATP1B1. 13 13.1 Niraparib Carcinogenicity studies have not been conducted with niraparib. Niraparib was clastogenic in an in vitro mammalian chromosomal abe”
NegatedCarcinogenicity: “in the testes. Abiraterone acetate was not carcinogenic in female rats at exposure levels up to 0.8 times the human clinical exposure (1,000 mg daily) based on AUC. Abirater”
NegatedCarcinogenicity: “based on AUC. Abiraterone acetate was not carcinogenic in a 6-month study in the transgenic (Tg.rasH2) mouse. Abiraterone acetate and abiraterone were not mutagenic in an i”
NegatedGenotoxicity / mutagenicity: “for genotoxicity in humans. Niraparib was not mutagenic in a bacterial reverse mutation assay (Ames) test. Fertility studies in animals have not been conducted with nirapari”
NegatedGenotoxicity / mutagenicity: “Abiraterone acetate and abiraterone were not mutagenic in an in vitro microbial mutagenesis (Ames) assay or clastogenic in an in vitro cytogenetic assay using primary human”
NegatedGenotoxicity / mutagenicity: “were not mutagenic in an in vitro microbial mutagenesis (Ames) assay or clastogenic in an in vitro cytogenetic assay using primary human lymphocytes or an in vivo rat micr”
NegatedGenotoxicity / mutagenicity: “in vitro microbial mutagenesis (Ames) assay or clastogenic in an in vitro cytogenetic assay using primary human lymphocytes or an in vivo rat micronucleus assay. In repeat-dose”
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.