Screening report

E.R. Squibb & Sons, L.L.C. · Package insert of record

ZENBEXUS (IBERDOMIDE)

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.”
5 / 6NIOSH hazard criteria present in this label
Special handling: present in the label
Carcinogenicity: present in the label
Developmental: present in the label
Reproductive: present in the label
Genotoxicity: present in the label
Organ toxicity: not found
Manufacturer special-handling information
12 passages in the label

“…(12.3) ] . 2.6 Administration ZENBEXUS is a hazardous drug. Follow applicable special handling and disposal procedures. 1 Take ZENBEXUS at approximately the same time each day wi…”

2 more passages

“…were MRD negative. 15 REFERENCES 1. “OSHA Hazardous Drugs.” OSHA . http://www.osha.gov/hazardous-drugs 16 HOW SUPPLIED/STORAGE AND HANDLING ZENBEXUS™ (iberdomide) capsules, 0.7…”

“…ZENBEXUS is a hazardous drug. Follow applicable special handling and disposal procedures. 1 Take ZENBEXUS at approximately the same time each day with or without food [see Clinical Pha…”

Carcinogenicity
12 passages in the label

“…according to current practice guidelines. 5.6 Second Primary Malignancies In the EXCALIBER-RRMM study, at a median follow-up time of 16 months, second primary malignancies (SPM) occurred in…”

2 more passages

“…study, at a median follow-up time of 16 months, second primary malignancies (SPM) occurred in 6.9% of patients in the IberDd arm and in 4.9% of patients in the daratumumab and hyaluronidase-f…”

“…current practice guidelines. 5.6 Second Primary Malignancies In the EXCALIBER-RRMM study, at a median follow-up time of 16 months, second primary malignancies (SPM) occurred in 6.9…”

Genotoxicity / mutagenicity
1 passage in the label

“…bacterial reverse mutation (Ames) assay but was clastogenic in the in vitro assay using human peripheral blood lymphocytes. Subsequently, iberdomide was negative in the in vivo…”

Developmental / embryo-fetal toxicity
40 passages in the label

“…STEARIC ACID light gray Ivory BMS;1;mg WARNING: EMBRYO-FETAL TOXICITY and SERIOUS VENOUS AND ARTERIAL THROMBOEMBOLISM EMBRYO-FETAL TOXICITY ZENBEXUS is contraindicated in pregnancy…”

2 more passages

“…and SERIOUS VENOUS AND ARTERIAL THROMBOEMBOLISM EMBRYO-FETAL TOXICITY ZENBEXUS is contraindicated in pregnancy. ZENBEXUS is embryo-fetal toxic in animals and can cause birth defect…”

“…is contraindicated in pregnancy. ZENBEXUS is embryo-fetal toxic in animals and can cause birth defects or embryo-fetal death in humans. In females of reproductive potential, obt…”

Reproductive / fertility toxicity
5 passages in the label

“…even where there has been a history of infertility, unless due to hysterectomy. Females of reproductive potential should be referred to a qualified provider of contracept…”

2 more passages

“…use birth control even if you have a history of infertility, unless you have had a hysterectomy. • Talk to your healthcare provider about birth control methods that you can use be…”

Animal study“…were not evaluated. Female rabbits had reduced fertility and increased pre- and post-implantation loss at ≥5 mg/kg/day (approximately 50-fold greater than the human exposure at…”

Set aside: found but not counted (9)
NegatedCarcinogenicity: “OCT2, MRP2, MATE1, or MATE2-K. 13 13.1 Carcinogenesis Carcinogenicity studies have not been conducted for iberdomide. Mutagenesis Iberdomide was not mutagenic in vitro i”
NegatedCarcinogenicity: “MATE1, or MATE2-K. 13 13.1 Carcinogenesis Carcinogenicity studies have not been conducted for iberdomide. Mutagenesis Iberdomide was not mutagenic in vitro in a bacterial r”
NegatedGenotoxicity / mutagenicity: “studies have not been conducted for iberdomide. Mutagenesis Iberdomide was not mutagenic in vitro in a bacterial reverse mutation (Ames) assay but was clastogenic in the in vi”
NegatedGenotoxicity / mutagenicity: “for iberdomide. Mutagenesis Iberdomide was not mutagenic in vitro in a bacterial reverse mutation (Ames) assay but was clastogenic in the in vitro assay using human periphera”
NegatedGenotoxicity / mutagenicity: “in rats and, therefore, iberdomide is not genotoxic. In the 9-month monkey study, animals were treated with oral doses of up to 0.4 mg/kg/day. Testicular hypospermatog”
NegatedGenotoxicity / mutagenicity: “iberdomide was negative in the in vivo micronucleus assay and DNA damage in liver (Comet assay) in rats and, therefore, iberdomide is not genotoxic. In the 9-month monke”
NegatedGenotoxicity / mutagenicity: “negative in the in vivo micronucleus assay and DNA damage in liver (Comet assay) in rats and, therefore, iberdomide is not genotoxic. In the 9-month monkey study, animals were”
NegatedDevelopmental / embryo-fetal toxicity: “action with thalidomide. Thalidomide is a human teratogen, inducing a high frequency of severe and life-threatening birth defects such as amelia (absence of limbs), phocomelia (”
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.

ZENBEXUS (IBERDOMIDE): 5 of 6 NIOSH criteria in the label | Clariscope