BALVERSA (ERDAFITINIB): 2 of 6 NIOSH criteria in the label

Screening report

Janssen Products LP · Package insert of record

BALVERSA (ERDAFITINIB)

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

25 passages in the label

“…dose modifications when required. ( 2.3 , 5.2 ) Embryo-fetal toxicity: Can cause fetal harm. Advise patients of the potential risk to the fetus and to use effective contraception (…”

2 more passages

“…2 [see Dosage and Administration (2.3) ]. 5.3 Embryo-Fetal Toxicity Based on the mechanism of action and findings in animal reproduction studies, BALVERSA can cause fetal harm wh…”

“…when administered to a pregnant woman. In an embryo-fetal toxicity study, oral administration of erdafitinib to pregnant rats during the period of organogenesis caused malformat…”

Reproductive / fertility toxicity

4 passages in the label

“…of reproductive potential that BALVERSA may impair fertility [see (8.3) ]. Product of Switzerland Manufactured for: Janssen Products, LP Horsham, PA 19044, USA Under license from…”

2 more passages

“…one month after the last dose [see (8.2) ]. Infertility Advise females of reproductive potential that BALVERSA may impair fertility [see (8.3) ]. Product of Switzerland Manu…”

Animal study“…on findings from animal studies, BALVERSA may impair fertility in females of reproductive potential [see (13.1) ] . 8.4 Pediatric Use Safety and effectiveness of BALVERSA in pediat…”

Set aside: found but not counted (5)

NegatedCarcinogenicity: “among various ethnic groups. 13 13.1 Carcinogenicity studies have not been conducted with erdafitinib. Erdafitinib was not mutagenic in a bacterial reverse mutation (A”

NegatedGenotoxicity / mutagenicity: “conducted with erdafitinib. Erdafitinib was not mutagenic in a bacterial reverse mutation (Ames) assay and was not clastogenic in an in vitro micronucleus or an in vivo rat bo”

NegatedGenotoxicity / mutagenicity: “reverse mutation (Ames) assay and was not clastogenic in an in vitro micronucleus or an in vivo rat bone marrow micronucleus assay. Fertility studies in animals have not b”

NegatedGenotoxicity / mutagenicity: “assay and was not clastogenic in an in vitro micronucleus or an in vivo rat bone marrow micronucleus assay. Fertility studies in animals have not been conducted with erdafitinib”

NegatedGenotoxicity / mutagenicity: “micronucleus or an in vivo rat bone marrow micronucleus assay. Fertility studies in animals have not been conducted with erdafitinib. In the 3-month repeat-dose toxicity study”

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.