Screening report

Pfizer Laboratories Div Pfizer Inc · Package insert of record

BOSULIF (BOSUTINIB)

NIOSH Table 2DailyMed (opens the full label on DailyMed in a new tab)
On the NIOSH List — Table 2
This drug appears on the NIOSH List of Hazardous Drugs, 2024 (Table 2).
3 / 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: not found
Organ toxicity: present in the label
Developmental / embryo-fetal toxicity
16 passages in the label

“…and during therapy with BOSULIF. ( 5.6 ) • Embryo-Fetal Toxicity: BOSULIF can cause fetal harm. Advise female patients of reproductive potential of potential risk to a fetus a…”

2 more passages

“…[see Dosage and Administration (2.5) ] . 5.7 Embryo-Fetal Toxicity Based on findings from animal studies and its mechanism of action, BOSULIF can cause fetal harm when administe…”

“…of 400 or 500 mg/day, respectively). In an embryo-fetal development study conducted in rabbits, bosutinib was administered orally to pregnant animals during the period of orga…”

Reproductive / fertility toxicity
2 passages in the label

“…dose of 70 mg/kg/day of bosutinib resulted in reduced fertility in males as demonstrated by 16% reduction in the number of pregnancies. There were no lesions in the male reproductive…”

1 more passage

Animal study“…findings from animal studies, BOSULIF may cause reduced fertility in females and males of reproductive potential [see (13.1) ] . 8.4 Pediatric Use The safety and effectiveness of BOSU…”

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

“…similarly to adults. 2.4 Dosage Adjustments for Myelosuppression Dose reductions for severe or persistent neutropenia and thrombocytopenia are described below (Table 3). Table 3: Dose…”

2 more passages

“…reduce, or discontinue BOSULIF. ( 2.3 , 5.1 ) • Myelosuppression: Monitor blood counts and manage as necessary. Withhold, dose reduce, or discontinue BOSULIF. ( 2.4 , 5.2 ) • Hepatic T…”

“…(2.3) and Adverse Reactions (6) ] . 5.2 Myelosuppression Thrombocytopenia, anemia and neutropenia occur with BOSULIF treatment. Perform complete blood counts weekly for the fir…”

Set aside: found but not counted (8)
NegatedCarcinogenicity: “(OCT)1, and OCT2. 13 13.1 Bosutinib was not carcinogenic in rats or transgenic mice. The rat 2-year carcinogenicity study was conducted at bosutinib oral doses up to 25 mg/kg”
Supporting onlyCarcinogenicity: “in rats or transgenic mice. The rat 2-year carcinogenicity study was conducted at bosutinib oral doses up to 25 mg/kg in males and 15 mg/kg in females. Exposures at these do”
NegatedGenotoxicity / mutagenicity: “oral doses up to 60 mg/kg. Bosutinib was not mutagenic or clastogenic in a battery of tests, including the bacteria reverse mutation assay (Ames Test), the in vitro assay u”
NegatedGenotoxicity / mutagenicity: “up to 60 mg/kg. Bosutinib was not mutagenic or clastogenic in a battery of tests, including the bacteria reverse mutation assay (Ames Test), the in vitro assay using human peri”
NegatedGenotoxicity / mutagenicity: “including the bacteria reverse mutation assay (Ames Test), the in vitro assay using human peripheral blood lymphocytes and the micronucleus test in orally treated male mice. In”
NegatedGenotoxicity / mutagenicity: “human peripheral blood lymphocytes and the micronucleus test in orally treated male mice. In a rat fertility study, drug-treated males were mated with untreated females, or un”
NegatedReproductive / fertility toxicity: “BOSULIF and for 2 weeks after the last dose. Infertility The risk of infertility in females or males of reproductive potential has not been studied in humans. Based on findings”
NegatedReproductive / fertility toxicity: “after the last dose. Infertility The risk of infertility in females or males of reproductive potential has not been studied in humans. Based on findings from animal studies, BO”
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.