Screening report

Syndax Pharmaceuticals, Inc. · Package insert of record

Revuforj (REVUMENIB)

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: present in the label
Developmental: present in the label
Reproductive: present in the label
Genotoxicity: not found
Organ toxicity: not found
Carcinogenicity
27 passages in the label

“…recommended dosage for relapsed or refractory acute leukemia [see Adverse Reactions (6.1) ] . Among those with a KMT2A translocation, DS occurred in 33% of patients with acute myel…”

2 more passages

“…(AML), 33% of patients with mixed-phenotype acute leukemia (MPAL), and 9% of patients with acute lymphoblastic leukemia (ALL); DS occurred in 18% of patients with NPM1 mutated AM…”

“…recommended dosage for relapsed or refractory acute leukemia in clinical trials, QTc interval prolongation was reported as an adverse reaction in 86 (36%) of patients. QTc interval…”

Developmental / embryo-fetal toxicity
17 passages in the label

“…None. None. ( 4 ) 5 WARNINGS AND PRECAUTIONS Embryo-Fetal Toxicity : Can cause fetal harm. Advise females of reproductive potential and males with female partners of reproductiv…”

2 more passages

“…[see Dosage and Administration (2.3) ] . 5.3 Embryo-Fetal Toxicity Based on findings in animals and its mechanism of action, REVUFORJ can cause fetal harm when administered to a…”

“…adverse developmental outcomes, including embryo-fetal mortality, malformations, and altered fetal growth at maternal exposures approximately 0.5 times the human exposure (AU…”

Reproductive / fertility toxicity
4 passages in the label

“…of reproductive potential of the potential for impaired fertility from REVUFORJ [see (8.3) , (13.1) ] . Drug Interactions Advise patients to inform their healthcare providers of all…”

2 more passages

“…for 1 week after the last dose [see (8.2) ] . Infertility Advise females and males of reproductive potential of the potential for impaired fertility from REVUFORJ [see (8.3) ,…”

Animal study“…Based on findings in animals, REVUFORJ may impair fertility. The effects on fertility were reversible [see (13.1) ] . 8.4 Pediatric Use The safety and efficacy of REVUFORJ have…”

Set aside: found but not counted (8)
NegatedCarcinogenicity: “OATP1B1, OATP1B3, and MATE2-K. 13 13.1 Carcinogenicity studies have not been conducted with revumenib. In a repeat dose toxicity study in rats treated with revumenib for”
NegatedCarcinogenicity: “to adult patients with relapsed/refractory acute leukemia Parameter Dosage 160 mg twice daily (with strong CYP3A4 inhibitors) 270 mg twice daily (without strong CYP3A4 inhibitor”
NegatedCarcinogenicity: “has not improved after previous treatment(s). acute myeloid leukemia with a nucleophosmin 1 (NPM1) mutation whose disease has come back or has not improved after previous treatment(s) and”
NegatedGenotoxicity / mutagenicity: “organs in one animal. Revumenib was not genotoxic in an in vitro bacterial reverse mutation (Ames) assay, an in vitro micronucleus assay in human peripheral blood lymp”
NegatedGenotoxicity / mutagenicity: “reverse mutation (Ames) assay, an in vitro micronucleus assay in human peripheral blood lymphocytes, or an in vivo rat peripheral blood reticulocyte micronucleus assay. Fertil”
NegatedGenotoxicity / mutagenicity: “or an in vivo rat peripheral blood reticulocyte micronucleus assay. Fertility studies in animals have not been conducted with revumenib. In a repeat dose toxicity study in dogs tre”
NegatedDevelopmental / embryo-fetal toxicity: “Pharmacology (12.1) ], REVUFORJ can cause fetal harm when administered to a pregnant woman. There are no available data on REVUFORJ use in pregnant women to evaluate for a”
NegatedDevelopmental / embryo-fetal toxicity: “Clinical Pharmacology (12.1) ], REVUFORJ can cause fetal harm when administered to a pregnant woman. There are no available data on REVUFORJ use in pregnant women to evaluate for a”
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.