BEQALZI (sonrotoclax): 2 of 6 NIOSH criteria in the label

Screening report

BeOne Medicines USA, Inc. · Package insert of record

BEQALZI (sonrotoclax)

Not on the NIOSH ListDailyMed

Developmental / reproductive language

The label notes developmental and/or reproductive toxicity. Many drugs carry this language and are not classified as hazardous.

2 / 6NIOSH hazard criteria present in this label

Special handling

Carcinogenicity

Developmental

Reproductive

Genotoxicity

Organ toxicity

Developmental / embryo-fetal toxicity

16 passages in the label

“…Monitor blood counts regularly. ( 5.3 ) Embryo-Fetal Toxicity : Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. (…”

2 more passages

“…[see Dosage and Administration (2.3) ] . 5.4 Embryo-Fetal Toxicity Based on findings in animals and its mechanism of action, BEQALZI can cause fetal harm when administered to a…”

“…harm when administered to a pregnant woman. In embryo-fetal development toxicity studies conducted in pregnant mice and rabbits, oral administration of sonrotoclax during the peri…”

Reproductive / fertility toxicity

3 passages in the label

“…of reproductive potential that BEQALZI may impair fertility [see (8.3) ] . Administration Instructions Advise patients to take BEQALZI exactly as prescribed and not to change th…”

2 more passages

“…for 1 week after the last dose [see (8.2) ] . Infertility Advise males and females of reproductive potential that BEQALZI may impair fertility [see (8.3) ] . Administration In…”

Animal study“…BEQALZI and for 1 week after the last dose. Infertility Based on findings in animals, BEQALZI may impair male and female fertility. Fertility findings were reversible in anima…”

Set aside: found but not counted (10)

Supporting onlyManufacturer special-handling information: “nonclinical studies, sonrotoclax demonstrated cytotoxicity in cancer cells overexpressing BCL-2, with a series of intrinsic apoptotic events, including caspase activation. 12.”

NegatedCarcinogenicity: “OCT1, OCT2, MATE1, or MATE2-K. 13 13.1 Carcinogenesis Carcinogenicity studies have not been conducted with sonrotoclax. Mutagenesis Sonrotoclax was not mutagenic in a ba”

NegatedCarcinogenicity: “MATE1, or MATE2-K. 13 13.1 Carcinogenesis Carcinogenicity studies have not been conducted with sonrotoclax. Mutagenesis Sonrotoclax was not mutagenic in a bacterial mutagen”

Supporting onlyCarcinogenicity: “a low-fat meal in patients with mature B-cell malignancies. There is insufficient information to characterize the QTc effects of sonrotoclax at higher concentrations above recomm”

NegatedGenotoxicity / mutagenicity: “have not been conducted with sonrotoclax. Mutagenesis Sonrotoclax was not mutagenic in a bacterial mutagenicity (Ames) assay and not clastogenic in a chromosome aberrati”

NegatedGenotoxicity / mutagenicity: “sonrotoclax. Mutagenesis Sonrotoclax was not mutagenic in a bacterial mutagenicity (Ames) assay and not clastogenic in a chromosome aberration assay in mammalian cells or i”

NegatedGenotoxicity / mutagenicity: “Sonrotoclax was not mutagenic in a bacterial mutagenicity (Ames) assay and not clastogenic in a chromosome aberration assay in mammalian cells or in an in vivo bone marrow”

NegatedGenotoxicity / mutagenicity: “a bacterial mutagenicity (Ames) assay and not clastogenic in a chromosome aberration assay in mammalian cells or in an in vivo bone marrow micronucleus assay in mice. Fertil”

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.