Screening report

ADC Therapeutics America, Inc. · Package insert of record

ZYNLONTA (LONCASTUXIMAB TESIRINE)

NIOSH Table 1DailyMed (opens the full label on DailyMed in a new tab)
On the NIOSH List — Table 1
This drug appears on the NIOSH List of Hazardous Drugs, 2024 (Table 1).
5 / 6NIOSH hazard criteria present in this label
Special handling: present in the label
Carcinogenicity: not found
Developmental: present in the label
Reproductive: present in the label
Genotoxicity: present in the label
Organ toxicity: present in the label
Manufacturer special-handling information
9 passages in the label

“…appropriate aseptic technique. ZYNLONTA is a hazardous drug. Follow applicable special handling and disposal procedures. 1 Dose calculation Calculate the total dose (mg) required…”

2 more passages

“…(range 1.1 to 8.1). 15 REFERENCES 1. "OSHA Hazardous Drugs." OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html 16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied ZYNLONTA…”

“…ZYNLONTA is a hazardous drug. Follow applicable special handling and disposal procedures. 1 Dose calculation Calculate the total dose (mg) required based on the patient's weight and pr…”

Genotoxicity / mutagenicity
9 passages in the label

“…to a pregnant woman because it contains a genotoxic compound (SG3199) and affects actively dividing cells. Advise pregnant women of the potential risk to a fetus. Advise…”

2 more passages

“…to a pregnant woman, because it contains a genotoxic compound (SG3199) and affects actively dividing cells [see Clinical Pharmacology (12.1) and (13.1) ] . There are no…”

“…of ZYNLONTA, SG3199, crosslinks DNA, is genotoxic, and is toxic to rapidly dividing cells, suggesting it has the potential to cause embryotoxicity and teratogenicity.…”

Developmental / embryo-fetal toxicity
15 passages in the label

“…has the potential to cause embryotoxicity and teratogenicity. 8.2 Lactation Risk Summary There is no data on the presence of loncastuximab tesirine-lpyl or SG3199 in human mil…”

2 more passages

“…consultation should be considered. ( 5.5 ) Embryo-Fetal Toxic ity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. (…”

“…should be considered [see (13) ]. 5.6 Embryo-Fetal Toxicity Based on its mechanism of action, ZYNLONTA can cause embryo-fetal harm when administered to a pregnant woman b…”

Reproductive / fertility toxicity
2 passages in the label
Animal data

“…the results from animal studies, ZYNLONTA may impair fertility in males. The effects were not reversible in male cynomolgus monkeys during the 12-week drug-free period [see (13.1)…”

1 more passage

“…7 months after the last dose [see (13.1) ] . Infertility Males Based on the results from animal studies, ZYNLONTA may impair fertility in males. The effects were not reversible…”

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

“…( 5.1 ) 2/2026 Warnings and Precautions, Hepatotoxicity, Including Drug-Induced Liver Injury ( 5.4 ) 1/2026 1 INDICATIONS AND USAGE ZYNLONTA is indicated for the treatment…”

2 more passages

“…recurs Grade 3 or higher Discontinue ZYNLONTA Hepatotoxicity [ see Warnings and Precautions (5.4) ] Grade 3 or higher increase in AST or ALT or suspected DILI Withhold ZYNLONTA…”

“…for infection and treat promptly. ( 5.3 ) Hepatotoxicity, Including Drug-Induced Liver Injury : Monitor liver function tests during treatment. Withhold or permanently discon…”

Drug-class hint
Context only · not counted

“…of Action Loncastuximab tesirine-lpyl is an antibody-drug conjugate (ADC) targeting CD19. The monoclonal IgG1 kappa antibody component binds to human CD19, a transmembrane protein express…”

Set aside: found but not counted (2)
NegatedCarcinogenicity: “efficacy, or safety is unknown. 13 13.1 Carcinogenicity studies have not been conducted with loncastuximab tesirine-lpyl or SG3199. SG3199 was genotoxic in an in vitro mi”
NegatedDevelopmental / embryo-fetal toxicity: “. Data Animal Data Animal reproductive or developmental toxicity studies were not conducted with loncastuximab tesirine-lpyl. The cytotoxic component of ZYNLONTA, SG3199, crosslinks DN”
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.