Screening report

Genentech, Inc. · Package insert of record

Itovebi (INAVOLISIB)

Not on the NIOSH ListDailyMed (opens the full label on DailyMed in a new tab)
Carcinogenic / genotoxic findings in the label
The label reports carcinogenicity and/or genotoxicity findings — among the criteria NIOSH uses to identify hazardous drugs.
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: present in the label
Organ toxicity: not found
Genotoxicity / mutagenicity
2 passages in the label

“…reverse mutation (Ames) assay. Inavolisib was clastogenic in an in vitro human lymphocyte micronucleus assay. Inavolisib was not genotoxic in an in vivo rat bone marrow micron…”

1 more passage

“…was clastogenic in an in vitro human lymphocyte micronucleus assay. Inavolisib was not genotoxic in an in vivo rat bone marrow micronucleus test and did not induce DNA break in a l…”

Developmental / embryo-fetal toxicity
16 passages in the label

“…if severe diarrhea occurs. ( 2.4 , 5.3 ) Embryo-Fetal Toxicity : ITOVEBI can cause fetal harm. Advise patients of potential risk to a fetus and to use effective non-hormonal…”

2 more passages

“…[see Dosage and Administration (2.4) ] . 5.4 Embryo-Fetal Toxicity Based on findings in animals and its mechanism of action, ITOVEBI can cause fetal harm when administered to a…”

“…adverse developmental outcomes, including embryo-fetal mortality, structural abnormalities, and alterations to growth at maternal exposures approximately equivalent to the hu…”

Reproductive / fertility toxicity
6 passages in the label

“…of reproductive potential that ITOVEBI may impair fertility [see (8.3) ] . Refer to the Full Prescribing Information of palbociclib and fulvestrant for infertility information.…”

2 more passages

“…and fulvestrant for contraception and infertility information. ITOVEBI can cause fetal harm when administered to a pregnant woman [see (8.1) ] . Pregnancy Testing Veri…”

“…and fulvestrant for lactation information. Infertility Advise females and males of reproductive potential that ITOVEBI may impair fertility [see (8.3) ] . Refer to the Full…”

Set aside: found but not counted (4)
NegatedCarcinogenicity: “OCT2, OAT1, OAT3, MATE1, or MATE2K. 13 13.1 Carcinogenicity studies with inavolisib have not been conducted. Inavolisib was not mutagenic in the bacterial reverse mutation (A”
NegatedGenotoxicity / mutagenicity: “have not been conducted. Inavolisib was not mutagenic in the bacterial reverse mutation (Ames) assay. Inavolisib was clastogenic in an in vitro human lymphocyte micronucle”
NegatedGenotoxicity / mutagenicity: “micronucleus assay. Inavolisib was not genotoxic in an in vivo rat bone marrow micronucleus test and did not induce DNA break in a liver comet assay. Fertility studie”
NegatedGenotoxicity / mutagenicity: “was not genotoxic in an in vivo rat bone marrow micronucleus test and did not induce DNA break in a liver comet assay. Fertility studies with inavolisib have not been conducted. 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.