Screening report

Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. · Package insert of record

Besponsa (INOTUZUMAB OZOGAMICIN)

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
8 passages in the label

“…and dilution. Reconstitution : • BESPONSA is a hazardous drug. Follow applicable special handling and disposal procedures. 1 • Calculate the dose (mg) and number of vial(s) of BESPO…”

2 more passages

“…on RQ-PCR. Figure 1 15. REFERENCES 1. OSHA Hazardous Drugs. OSHA. https://www.osha.gov/hazardous-drugs 16. HOW SUPPLIED/STORAGE AND HANDLING How Supplied BESPONSA (inotuzumab oz…”

“…BESPONSA is a hazardous drug. Follow applicable special handling and disposal procedures. 1 • Calculate the dose (mg) and number of vial(s) of BESPONSA required. • Reconstitute each vial with 4 mL…”

Genotoxicity / mutagenicity
2 passages in the label
Animal data

“…agent released from inotuzumab ozogamicin) was mutagenic in an in vitro bacterial reverse mutation (Ames) assay. In a female fertility and early embryonic development study,…”

1 more passage

“…dose, based on AUC). Inotuzumab ozogamicin was clastogenic in vivo in the bone marrow of male mice that received single doses ≥ 1.1 mg/m 2 . This is consistent with the known i…”

Developmental / embryo-fetal toxicity
21 passages in the label

“…known to prolong QT interval. ( 5.5 ) • Embryo-fetal toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use ef…”

2 more passages

“…(7) , Clinical Pharmacology (12.2) ] ). 5.6 Embryo-Fetal Toxicity Based on its mechanism of action and findings from animal studies, BESPONSA can cause embryo-fetal harm when a…”

“…from animal studies, BESPONSA can cause embryo-fetal harm when administered to a pregnant woman. In animal studies, inotuzumab ozogamicin caused embryo-fetal toxicities, st…”

Reproductive / fertility toxicity
3 passages in the label
Animal data

“…Based on findings in animals, BESPONSA may impair fertility in females of reproductive potential [see (13.1) ] . Males Based on findings in animals, BESPONSA may impair fertilit…”

2 more passages

“…Based on findings in animals, BESPONSA may impair fertility in males of reproductive potential [see (13.1) ] . 8.4 Pediatric Use The safety and effectiveness of BESPONSA in pedi…”

“…5 months after the last dose [see (13.1) ] . Infertility Females Based on findings in animals, BESPONSA may impair fertility in females of reproductive potential [see (13.1)…”

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

“…(2.4) 3/2024 Warnings and Precautions, Hepatotoxicity, Including Hepatic Veno-occlusive Disease (VOD) (also known as Sinusoidal Obstruction Syndrome) (5.1) 3/2024 Warning…”

2 more passages

“…information for complete boxed warning. • Hepatotoxicity, including fatal and life-threatening VOD occurred in patients who received BESPONSA. ( 5.1 ) • A higher post-HSCT n…”

“…occurred in patients receiving BESPONSA ( 5.2 ) HEPATOTOXICITY, INCLUDING VOD • Hepatotoxicity, including fatal and life-threatening VOD occurred in patients with relapsed or refr…”

Drug-class hint
Context only · not counted

“…Action Inotuzumab ozogamicin is a CD22-directed antibody drug conjugate (ADC). Inotuzumab recognizes human CD22. The small molecule, N-acetyl-gamma-calicheamicin, is a cytotoxic agent that is…”

Set aside: found but not counted (2)
NegatedCarcinogenicity: “inotuzumab ozogamcin. 13. 13.1 Formal carcinogenicity studies have not been conducted with inotuzumab ozogamicin. In toxicity studies, rats were dosed weekly for 4 or 2”
NegatedDevelopmental / embryo-fetal toxicity: “was observed in the absence of any effects on embryo-fetal development. 8.2 Lactation Risk Summary There are no data on the presence of inotuzumab ozogamicin or its metabolites i”
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.