Screening report

Nuvalent, Inc. · Package insert of record

JIDEYTRO (ZIDESAMTINIB)

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: not found
Developmental: present in the label
Reproductive: present in the label
Genotoxicity: present in the label
Organ toxicity: present in the label
Genotoxicity / mutagenicity
3 passages in the label
Animal data

“…studies with zidesamtinib were not conducted. Mutagenesis Zidesamtinib was genotoxic in the in vivo rat micronucleus assays. Zidesamtinib was not mutagenic in the in vitro b…”

2 more passages

“…not conducted. Mutagenesis Zidesamtinib was genotoxic in the in vivo rat micronucleus assays. Zidesamtinib was not mutagenic in the in vitro bacterial reverse mutation (Am…”

“…Zidesamtinib was genotoxic in the in vivo rat micronucleus assays. Zidesamtinib was not mutagenic in the in vitro bacterial reverse mutation (Ames) assay or clastogenic in an in…”

Developmental / embryo-fetal toxicity
17 passages in the label

“…discontinue JIDEYTRO based on severity. ( 5.6 ) 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 )] . 5.7 Embryo-Fetal Toxicity Based on literature reports in humans with congenital mutations leading to changes in tropomyosin receptor kin…”

“…during the period of organogenesis resulted in embryo-fetal mortality, alterations to growth, and structural abnormalities at maternal exposures approximately equivalent to the hu…”

Reproductive / fertility toxicity
6 passages in the label

“…not to breastfeed. ( 8.2 ) Infertility: May impair fertility. ( 8.3 ) 8.1 Pregnancy Risk Summary Based on literature reports in humans with congenital mutations leading to changes…”

2 more passages

“…of reproductive potential that JIDEYTRO may impair fertility [see ( 8.3 ) and ( 13.1 )] . Drug Interactions Advise patients to inform their healthcare providers of all concomit…”

“…Lactation : Advise not to breastfeed. ( 8.2 ) Infertility: May impair fertility. ( 8.3 ) 8.1 Pregnancy Risk Summary Based on literature reports in humans with congenital mutatio…”

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

“…arrhythmia) Permanently discontinue JIDEYTRO. Interstitial Lung Disease (ILD)/Pneumonitis [see Warnings and Precautions (5.3)] Grade 1 Withhold JIDEYTRO if ILD/pneumonitis occurs or is suspec…”

2 more passages

“…dose, or permanently discontinue. ( 5.2 ) Interstitial Lung Disease (ILD)/pneumonitis: Can cause ILD/pneumonitis. Monitor patients for new or worsening pulmonary symptoms indicative of IL…”

“…[see Dosage and Administration ( 2.3 )] . 5.3 Interstitial Lung Disease/Pneumonitis JIDEYTRO can cause severe or life-threatening interstitial lung disease (ILD) or pneumonitis. In the pooled…”

Drug-class hint
Context only · not counted

“…at least 1 prior ROS1 TKI with or without prior platinum-based chemotherapy or immunotherapy. Among the 117 patients with ROS1 TKI-pretreated NSCLC, the median age was 57 years (rang…”

Set aside: found but not counted (4)
NegatedCarcinogenicity: “OAT1, OAT3, OCT1, OCT2 or MATE2K. 13 13.1 Carcinogenesis Carcinogenicity studies with zidesamtinib were not conducted. Mutagenesis Zidesamtinib was genotoxic in the in vivo”
NegatedCarcinogenicity: “OCT2 or MATE2K. 13 13.1 Carcinogenesis Carcinogenicity studies with zidesamtinib were not conducted. Mutagenesis Zidesamtinib was genotoxic in the in vivo rat micronucle”
NegatedGenotoxicity / mutagenicity: “rat micronucleus assays. Zidesamtinib was not mutagenic in the in vitro bacterial reverse mutation (Ames) assay or clastogenic in an in vitro assay in human lymphoblastoid T”
NegatedGenotoxicity / mutagenicity: “bacterial reverse mutation (Ames) assay or clastogenic in an in vitro assay in human lymphoblastoid TK6 cells. Zidesamtinib did not induce DNA strand breaks in the comet as”
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.

JIDEYTRO (ZIDESAMTINIB): 4 of 6 NIOSH criteria in the label | Clariscope