Screening report

Novartis Pharmaceuticals Corporation · Package insert of record

SCEMBLIX (asciminib)

Not on the NIOSH ListDailyMed (opens the full label on DailyMed in a new tab)
Developmental / reproductive language
The label notes developmental and/or reproductive toxicity. Many drugs carry this language and are not classified as hazardous.
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: not found
Organ toxicity: present in the label
Developmental / embryo-fetal toxicity
23 passages in the label

“…treatment as clinically indicated. ( 5.5 ) Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use ef…”

2 more passages

“…[see Dosage and Administration (2.4)] . 5.6 Embryo-Fetal Toxicity Based on findings from animal studies and its mechanism of action, SCEMBLIX can cause fetal harm when administ…”

“…adverse developmental outcomes, including embryo-fetal mortality and malformations at maternal exposures (AUC) equivalent to or less than those in patients at the recommended…”

Reproductive / fertility toxicity
4 passages in the label

“…of reproductive potential of the potential for impaired fertility from SCEMBLIX [see (8.3), (13.1)] . Drug Interactions Advise patients that SCEMBLIX and certain other medicines, in…”

2 more passages

“…for 1 week after the last dose [see (8.2)] . Infertility Advise females of reproductive potential of the potential for impaired fertility from SCEMBLIX [see (8.3), (13.1)]…”

Animal study“…Based on findings in animals, SCEMBLIX may impair fertility in females of reproductive potential [see (13.1)] . The reversibility of the effect on fertility is unknown. 8.4 Pedi…”

Organ toxicity (verify at low doses)
4 passages in the label

“…None. None. ( 4 ) 5 WARNINGS AND PRECAUTIONS Myelosuppression: Severe thrombocytopenia and neutropenia events may occur. Monitor complete blood counts regularly during therapy and m…”

2 more passages

“…contraception. ( 5.6 , 8.1 , 8.3 ) 5.1 Myelosuppression Thrombocytopenia, neutropenia, and anemia have occurred in patients receiving SCEMBLIX. Thrombocytopenia occurred in 15…”

“…Monitor patients for signs and symptoms of myelosuppression. Based on the severity of thrombocytopenia and/or neutropenia, reduce dose, temporarily withhold, or permanently discon…”

Set aside: found but not counted (6)
Supporting onlyCarcinogenicity: “dose dependent manner. 13 13.1 In a 2-year carcinogenicity study, rats were administered oral doses of asciminib at 20, 66, and 200 mg/kg/day in males and 10, 30, and 66 mg/”
NegatedGenotoxicity / mutagenicity: “was not genotoxic in an in vitro bacterial mutagenicity (Ames) assay, an in vitro micronucleus assay in human peripheral blood lymphocytes (HPBL), or an in vivo rat perip”
NegatedGenotoxicity / mutagenicity: “is currently unknown. Asciminib was not genotoxic in an in vitro bacterial mutagenicity (Ames) assay, an in vitro micronucleus assay in human peripheral blood lymphocy”
NegatedGenotoxicity / mutagenicity: “mutagenicity (Ames) assay, an in vitro micronucleus assay in human peripheral blood lymphocytes (HPBL), or an in vivo rat peripheral blood reticulocyte micronucleus assay.”
NegatedGenotoxicity / mutagenicity: “or an in vivo rat peripheral blood reticulocyte micronucleus assay. In a combined male and female fertility and early embryonic development study in rats, animals were administered”
NegatedDevelopmental / embryo-fetal toxicity: “early termination of the dose group; a complete embryo-fetal examination was not conducted for this group. Adverse embryo-fetal findings were observed at 25 and 150 mg/kg; these do”
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.