REVTORPYK (gedatolisib): 2 of 6 NIOSH criteria in the label

Screening report

Celcuity Inc. · Package insert of record

REVTORPYK (gedatolisib)

Not on the NIOSH ListDailyMed

Developmental / reproductive language

The label notes developmental and/or reproductive toxicity. Many drugs carry this language and are not classified as hazardous.

2 / 6NIOSH hazard criteria present in this label

Special handling

Carcinogenicity

Developmental

Reproductive

Genotoxicity

Organ toxicity

Developmental / embryo-fetal toxicity

14 passages in the label

“…REVTORPYK based on severity. ( 2.4 , 5.3 ) Embryo-Fetal Toxicity: REVTORPYK can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contracepti…”

2 more passages

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

“…loss) [see Warnings and Precautions (5.3) ] . Embryo-Fetal Toxicity Inform pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females t…”

Reproductive / fertility toxicity

6 passages in the label

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

2 more passages

“…and palbociclib for contraception and infertility information. When used in combination with REVTORPYK, advise patients to use effective contraception during treatment a…”

“…Information of any of the individual products. Infertility Advise females and males of reproductive potential that REVTORPYK may impair fertility [see (8.3) ] . Refer to the Pr…”

Set aside: found but not counted (8)

NegatedCarcinogenicity: “OAT1, OAT3, OCT2, and BSEP. 13 13.1 Carcinogenesis Carcinogenicity studies have not been conducted with gedatolisib. Mutagenesis Gedatolisib was not mutagenic in vitr”

NegatedCarcinogenicity: “OCT2, and BSEP. 13 13.1 Carcinogenesis Carcinogenicity studies have not been conducted with gedatolisib. Mutagenesis Gedatolisib was not mutagenic in vitro in a bacteria”

NegatedGenotoxicity / mutagenicity: “have not been conducted with gedatolisib. Mutagenesis Gedatolisib was not mutagenic in vitro in a bacterial reverse mutation (Ames) assay and was not clastogenic in an i”

NegatedGenotoxicity / mutagenicity: “gedatolisib. Mutagenesis Gedatolisib was not mutagenic in vitro in a bacterial reverse mutation (Ames) assay and was not clastogenic in an in vitro human lymphocyte chromos”

NegatedGenotoxicity / mutagenicity: “aberration assay. Gedatolisib was not genotoxic in an in vivo rat bone marrow micronucleus assay. Fertility studies with gedatolisib have not been conducted. In re”

NegatedGenotoxicity / mutagenicity: “reverse mutation (Ames) assay and was not clastogenic in an in vitro human lymphocyte chromosomal aberration assay. Gedatolisib was not genotoxic in an in vivo rat bone ma”

NegatedGenotoxicity / mutagenicity: “not clastogenic in an in vitro human lymphocyte chromosomal aberration assay. Gedatolisib was not genotoxic in an in vivo rat bone marrow micronucleus assay. Fertility studies with gedatol”

NegatedGenotoxicity / mutagenicity: “was not genotoxic in an in vivo rat bone marrow micronucleus assay. Fertility studies with gedatolisib have not been conducted. In repeated-dose toxicity studies, gedatolisib was”

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.