Screening report

Jazz Pharmaceuticals, Inc. · Package insert of record

ZIIHERA (ZANIDATAMAB-HRII)

Not on the NIOSH ListDailyMed (opens the full label on DailyMed in a new tab)
Special-handling language in the label
The FDA label carries manufacturer special-handling information — for example cytotoxic, antineoplastic, or “special handling.”
3 / 6NIOSH hazard criteria present in this label
Special handling: present in the label
Carcinogenicity: not found
Developmental: present in the label
Reproductive: not found
Genotoxicity: not found
Organ toxicity: present in the label
Manufacturer special-handling information
3 passages in the label

“…polyvinylidene fluoride air filter (PVDF). o Closed System Transfer devices: acrylonitrile-butadiene-styrene (ABS), acrylic copolymer, polycarbonate (PC), polyisoprene (PI), poly…”

2 more passages

“…Zanidatamab-hrii induces complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC), and antibody-dependent cellular phagocytosis (ADCP). These m…”

“…cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC), and antibody-dependent cellular phagocytosis (ADCP). These mechanisms result in tumor growth inhibition and…”

Developmental / embryo-fetal toxicity
19 passages in the label

“…5.1 , 5.3 , 5.4 ) 08/2026 WARNING: DIARRHEA AND EMBRYO-FETAL TOXICITY ZIIHERA, in combination with fluoropyrimidine- and platinum-containing chemotherapy, with or without tislelizu…”

2 more passages

“…Warnings and Precautions ( 5.1 ), ( 8.5 )] . Embryo-Fetal Toxicity: Exposure to ZIIHERA during pregnancy can cause embryo-fetal harm. Advise patients of the risk and need for ef…”

“…Exposure to ZIIHERA during pregnancy can cause embryo-fetal harm. Advise patients of the risk and need for effective contraception [see Warnings and Precautions ( 5.2 ), ( 8.1 ,…”

Organ toxicity (verify at low doses)
1 passage in the label

“…included decreased ejection fraction and pneumonitis. Dosage interruptions due to adverse reactions, excluding temporary interruptions of ZIIHERA infusions due to infusion-…”

Drug-class hint
Context only · not counted

“…investigator choice of a fluoropyrimidine- and platinum-based chemotherapy (CAPOX or FP) or trastuzumab with CAPOX or FP [see Clinical Studies ( 14.1 )] . Treatment in each arm cont…”

Set aside: found but not counted (2)
NegatedCarcinogenicity: “have not been conducted to evaluate the carcinogenic or mutagenic potential of zanidatamab-hrii. Fertility studies with zanidatamab-hrii have not been conducted. 14 CLINI”
NegatedGenotoxicity / mutagenicity: “been conducted to evaluate the carcinogenic or mutagenic potential of zanidatamab-hrii. Fertility studies with zanidatamab-hrii have not been conducted. 14 CLINICAL STUDIES 1”
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.