Screening report

Janssen Biotech, Inc · Package insert of record

INLEXZO (GEMCITABINE INTRAVESICAL)

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.”
4 / 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: not found
Manufacturer special-handling information
10 passages in the label

“…and removal of INLEXZO. INLEXZO is a hazardous drug. Follow applicable special handling and disposal procedures while handling INLEXZO and during the insertion and removal…”

2 more passages

“…duration ≥12 months 51% (35) 15 REFERENCES OSHA Hazardous Drugs. Occupational Safety and Health Administration. Available at: https://www.osha.gov/hazardous-drugs (Accessed: 06 Septe…”

“…precautions, per local guidelines for handling hazardous drugs, to prevent skin or mucus membrane exposure while handling INLEXZO and during the insertion and removal procedure. If…”

Genotoxicity / mutagenicity
4 passages in the label
Animal data

“…have not been conducted. Gemcitabine was mutagenic in an in vitro mouse lymphoma (L5178Y) assay and was clastogenic in an in vivo mouse micronucleus assay. Dedicated an…”

2 more passages

“…in vitro mouse lymphoma (L5178Y) assay and was clastogenic in an in vivo mouse micronucleus assay. Dedicated animal fertility studies have not been conducted with gemcitabine i…”

“…of INLEXZO. Males Because of the potential for genotoxicity, advise males with female partners of reproductive potential to use effective contraception during treatment and f…”

Developmental / embryo-fetal toxicity
24 passages in the label

“…with MRI under certain conditions. ( 5.3 ) Embryo-Fetal Toxicity : Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. (…”

2 more passages

“…pulse sequence and a 3-Tesla MR system. 5.4 Embryo-Fetal Toxicity Based on animal data and its mechanism of action, INLEXZO can cause fetal harm when administered to a pregnant…”

“…Information Card and give it to the patient. Embryo-Fetal Toxicity Advise females of reproductive potential of the potential risk to a fetus and to inform their healthcare provi…”

Reproductive / fertility toxicity
6 passages in the label

“…of reproductive potential that INLEXZO may impair fertility [see (8.3) ] . Important Post-Treatment Instructions Instruct patients not to empty the bladder immediately prior to…”

2 more passages

“…after final removal of INLEXZO [see (8.2) ]. Infertility Advise males of reproductive potential that INLEXZO may impair fertility [see (8.3) ] . Important Post-Treatment Inst…”

Animal study“…Males Based on animal studies, INLEXZO may impair fertility in males of reproductive potential [see (13.1) ] . It is not known whether these effects on fertility are reversible.…”

Set aside: found but not counted (4)
NegatedCarcinogenicity: “Long-term animal studies to evaluate the carcinogenic potential of gemcitabine have not been conducted. Gemcitabine was mutagenic in an in vitro mouse lymphoma (L5178Y) as”
NegatedDevelopmental / embryo-fetal toxicity: “delays) and increased the incidence of fetal malformations (fused pulmonary artery, absence of gall bladder) at doses of 0.1 mg/kg/day. 8.2 Lactation Risk Summary There is no in”
NegatedDevelopmental / embryo-fetal toxicity: “of gemcitabine to pregnant rabbits resulted in fetotoxicity (decreased fetal viability, reduced litter sizes, and developmental delays) and increased the incidence of fetal mal”
NegatedDevelopmental / embryo-fetal toxicity: “delays) and increased the incidence of fetal malformations (fused pulmonary artery, absence of gall bladder) at doses of 0.1 mg/kg/day. 8.2 Lactation Risk Summary There is no in”
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.