Screening report

Taiho Pharmaceutical Co., Ltd. · Package insert of record

INQOVI (CEDAZURIDINE AND DECITABINE)

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

“…with the next schedule dose. INQOVI is a hazardous drug. Follow applicable special handling and disposal procedures. 1 2.4 Monitoring and Dosage Modifications for Adverse Reac…”

2 more passages

“…transfusion dependent. 15 REFERENCES 1. OSHA Hazardous Drugs. OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html 16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied INQOVI tab…”

“…INQOVI is a hazardous drug. Follow applicable special handling and disposal procedures. 1 2.4 Monitoring and Dosage Modifications for Adverse Reactions INQOVI Monotherapy for MDS or…”

Genotoxicity / mutagenicity
5 passages in the label

“…6 months after the last dose. Males Based on genotoxicity findings, advise males with female partners of reproductive potential to use effective contraception during treatm…”

2 more passages

“…combination have not been conducted. INQOVI is genotoxic. Decitabine increased mutation frequency in L5178Y mouse lymphoma cells, and mutations were produced in an E. coli la…”

“…in larvae of fruit flies. Cedazuridine was genotoxic in a reverse bacterial mutation assay (Ames assay) and in an in vitro chromosomal aberration study using human lympho…”

Developmental / embryo-fetal toxicity
19 passages in the label

“…or reduced dose as recommended. ( 2.3 , 5.1 ) Embryo-Fetal Toxicity : Can cause fetal harm. Advise patients of reproductive potential of the potential risk to a fetus and to use…”

2 more passages

“…[see Dosage and Administration (2.4) ] . 5.2 Embryo-Fetal Toxicity Based on findings from human data, animal studies, and its mechanism of action, INQOVI can cause fetal harm wh…”

“…developmental outcomes, including increased embryo-fetal mortality, alterations to growth, and structural abnormalities (see Data ) . Advise pregnant women of the potential ris…”

Reproductive / fertility toxicity
6 passages in the label

“…not to breastfeed. ( 8.2 ) Infertility : Can impair fertility. ( 8.3 ) 8.1 Pregnancy Risk Summary Based on findings from human data, animal studies, and its mechanism of action [see…”

2 more passages

“…males of reproductive potential that INQOVI may impair fertility [see (8.3) ]. Administration Advise patients to take INQOVI at approximately the same time each day on an empty stoma…”

“…females mated to males exposed in utero showed decreased fertility at 3 and 5 months of age (36% and 0% pregnancy rate, respectively). Follow up studies indicated that treatment of pregn…”

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

“…( 2.2 ) 5/2026 Warnings and Precautions, Myelosuppression ( 5.1 ) 5/2026 1 INDICATIONS AND USAGE INQOVI is a combination of decitabine, a nucleoside metabolic inhibitor, and ced…”

2 more passages

“…reductions in the order listed in Table 1 if myelosuppression persists after a dose reduction. Maintain or increase dose in subsequent cycles as clinically indicated. Table 1: Recom…”

“…Table 1: Recommended INQOVI Dose Reductions for Myelosuppression (Monotherapy for MDS or CMML) Dose Reduction Dosage First 1 tablet orally once daily on Days 1 through 4 Second 1 table…”

Set aside: found but not counted (4)
NegatedCarcinogenicity: “OAT3, OATP1B1, OATP1B3, or OCT2. 13 13.1 Carcinogenicity studies with decitabine, cedazuridine, or their combination have not been conducted. INQOVI is genotoxic. Decitabi”
Supporting onlyCarcinogenicity: “in a 39-year-old woman with a hematologic malignancy described multiple structural abnormalities after 6 cycles of therapy in the 18 th week of gestation. These abnormaliti”
NegatedDevelopmental / embryo-fetal toxicity: “was terminated. Animal Data No reproductive or developmental toxicity studies have been conducted with INQOVI or cedazuridine. In utero exposure to decitabine causes temporal-related defect”
NegatedOrgan toxicity (verify at low doses): “neutropenia) occurred in 1% of patients. Myelosuppression and worsening neutropenia may occur more frequently in the first or second treatment cycles and may not necessarily ind”
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.