Screening report

Bayer HealthCare Pharmaceuticals Inc. · Package insert of record

NUBEQA (darolutamide)

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.
3 / 6NIOSH hazard criteria present in this label
Special handling: not found
Carcinogenicity: not found
Developmental: present in the label
Reproductive: present in the label
Genotoxicity: present in the label
Organ toxicity: not found
Genotoxicity / mutagenicity
2 passages in the label

“…at doses up to 1000 mg/kg/day. Darolutamide was clastogenic in an in vitro chromosome aberration assay in human peripheral blood lymphocytes. Darolutamide did not induce mutatio…”

1 more passage

“…Darolutamide was clastogenic in an in vitro chromosome aberration assay in human peripheral blood lymphocytes. Darolutamide did not induce mutations in the bacterial reverse mutation (A…”

Developmental / embryo-fetal toxicity
10 passages in the label

“…who develop a seizure during treatment. ( 5.2 ) Embryo-Fetal Toxicity : NUBEQA can cause fetal harm and loss of pregnancy. Advise males with female partners of reproductive potenti…”

2 more passages

“…seizure [see Warnings and Precautions (5.2) ]. Embryo-Fetal Toxicity Inform patients that NUBEQA can be harmful to a developing fetus and can cause loss of pregnancy [see (8.1)…”

“…5.2 ) Embryo-Fetal Toxicity : NUBEQA can cause fetal harm and loss of pregnancy. Advise males with female partners of reproductive potential to use effective contraception. ( 5.…”

Reproductive / fertility toxicity
4 passages in the label

“…Advise male patients that NUBEQA may impair fertility [see (8.3) ]. Manufactured by: Orion Corporation, Orion Pharma, FI-02101 Espoo, Finland Manufactured for: Bayer Healt…”

2 more passages

“…[see Dosage and Administration (2.1) ]. Infertility Advise male patients that NUBEQA may impair fertility [see (8.3) ]. Manufactured by: Orion Corporation, Orion Pharma,…”

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

Set aside: found but not counted (7)
Supporting onlyManufacturer special-handling information: “to pain progression, and time to initiation of cytotoxic chemotherapy, were additional efficacy endpoints. Treatment with NUBEQA resulted in a statistically significant improve”
NegatedCarcinogenicity: “RasH2 transgenic mice for 26 weeks did not show carcinogenic potential at doses up to 1000 mg/kg/day. Darolutamide was clastogenic in an in vitro chromosome aberration assay in h”
NegatedGenotoxicity / mutagenicity: “reverse mutation (Ames) assay and was not genotoxic in the in vivo combined bone marrow micronucleus assay and the Comet assay in the liver and duodenum of the rat. Fert”
NegatedGenotoxicity / mutagenicity: “genotoxic in the in vivo combined bone marrow micronucleus assay and the Comet assay in the liver and duodenum of the rat. Fertility studies in animals have not been conducted wi”
NegatedDevelopmental / embryo-fetal toxicity: “who develop a seizure during treatment. 5.3 Embryo-Fetal Toxicity The safety and efficacy of NUBEQA have not been established in females. Based on its mechanism of action, NUBE”
NegatedDevelopmental / embryo-fetal toxicity: “[see Clinical Pharmacology (12.1) ]. Animal embryo-fetal developmental toxicology studies were not conducted with darolutamide. There are no human data on the use of NUBEQA in”
NegatedDevelopmental / embryo-fetal toxicity: “develop a seizure during treatment. 5.3 Embryo-Fetal Toxicity The safety and efficacy of NUBEQA have not been established in females. Based on its mechanism of action, NUBEQA can ca”
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.