Screening report

Day One Biopharmaceuticals, Inc. · Package insert of record

OJEMDA (TOVORAFENIB)

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
15 passages in the label

“…monitor growth in pediatric patients. ( 5.4 ) Embryo-Fetal Toxicity : Can cause fetal harm. Advise of the potential risk to a fetus and to use effective nonhormonal contraception…”

2 more passages

“…[see Adverse Reactions (6) , (8.4) ]. 5.5 Embryo-Fetal Toxicity Based on findings from animal studies and its mechanism of action, OJEMDA may cause fetal harm when administer…”

“…risk to a fetus. Data Animal Data In an embryo-fetal development study, once daily oral administration of tovorafenib to pregnant rats during the period of organogenesis fr…”

Reproductive / fertility toxicity
5 passages in the label

“…not to breastfeed. ( 8.2 ) Infertility : May impair fertility in males and females. ( 8.3 ) 8.1 Pregnancy Risk Summary Based on findings from animal studies and its mechanism of act…”

2 more passages

“…potential of the potential risk for impaired fertility with OJEMDA [see (13.1) ] . Dosing and Administration Inform patients and caregivers on how to take OJEMDA and what t…”

“…Lactation : Advise not to breastfeed. ( 8.2 ) Infertility : May impair fertility in males and females. ( 8.3 ) 8.1 Pregnancy Risk Summary Based on findings from animal studies a…”

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

“…consider permanent discontinuation of OJEMDA. Hepatotoxicity [see Warnings and Precautions (5.3) ] Grade 3 AST or ALT Grade 3 bilirubin Withhold OJEMDA. If improved to Grade ≤ 2…”

2 more passages

“…discontinue based on severity. ( 5.2 ) Hepatotoxicity: OJEMDA can cause hepatotoxicity. Monitor liver function tests prior to administration and during treatment. Withhol…”

“…( 5.2 ) Hepatotoxicity: OJEMDA can cause hepatotoxicity. Monitor liver function tests prior to administration and during treatment. Withhold, reduce the dose or permanently…”

Set aside: found but not counted (6)
NegatedCarcinogenicity: “concentrations. 13 13.1 Tovorafenib was not carcinogenic in the 6-month study in transgenic rasH2 mice that received oral doses up to 100 mg/kg/day. Tovorafenib was not mutag”
NegatedGenotoxicity / mutagenicity: “doses up to 100 mg/kg/day. Tovorafenib was not mutagenic in the in vitro bacterial reverse mutation (Ames) assay. Tovorafenib was not genotoxic in cultured human lymphocytes”
NegatedGenotoxicity / mutagenicity: “mutation (Ames) assay. Tovorafenib was not genotoxic in cultured human lymphocytes without metabolic activation. Tovorafenib induced chromosomal aberrations in cultured h”
NegatedGenotoxicity / mutagenicity: “concentration in vitro. Tovorafenib was not genotoxic in an in vivo rat bone marrow micronucleus assay. In a fertility and early embryonic development study in rats, anima”
NegatedGenotoxicity / mutagenicity: “was not genotoxic in an in vivo rat bone marrow micronucleus assay. In a fertility and early embryonic development study in rats, animals were administered tovorafenib doses of 37.”
Supporting onlyGenotoxicity / mutagenicity: “metabolic activation. Tovorafenib induced chromosomal aberrations in cultured human lymphocytes with metabolic activation at a single concentration in vitro. Tovorafenib was not genoto”
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.