Screening report

AstraZeneca Pharmaceuticals LP · Package insert of record

TAGRISSO (osimertinib)

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
16 passages in the label

“…to baseline or to Grade 0-2. ( 2.5 , 5.8 ) • Embryo-Fetal Toxicity : TAGRISSO can cause fetal harm. Advise females of potential risk to the fetus and to use effective contracept…”

2 more passages

“…[see Dosage and Administration (2.5) ] . 5.9 Embryo-Fetal Toxicity Based on data from animal studies and its mechanism of action, TAGRISSO can cause fetal harm when administered…”

“…[see Warnings and Precautions (5.8) ]. Embryo-Fetal Toxicity Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females t…”

Reproductive / fertility toxicity
2 passages in the label
Animal data

“…Based on animal studies, TAGRISSO may impair fertility in females and males of reproductive potential. The effects on female fertility showed a trend toward reversibility. It…”

1 more passage

“…the last dose of TAGRISSO [see (13.1) ] . Infertility Based on animal studies, TAGRISSO may impair fertility in females and males of reproductive potential. The effects on f…”

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

“…TAGRISSO based on severity. ( 2.5 , 5.2 ) • Cardiomyopathy : Occurred in 3.8% of patients. Conduct cardiac monitoring, including left ventricular ejection fraction (LVEF) assessm…”

2 more passages

“…[see Dosage and Administration (2.5) ]. 5.3 Cardiomyopathy TAGRISSO can cause cardiomyopathy, including cardiac failure, chronic cardiac failure, congestive heart failure, pulmon…”

“…(2.5) ]. 5.3 Cardiomyopathy TAGRISSO can cause cardiomyopathy, including cardiac failure, chronic cardiac failure, congestive heart failure, pulmonary edema or decreased ejection fr…”

Drug-class hint
Context only · not counted

“…during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-a…”

Set aside: found but not counted (4)
Supporting onlyManufacturer special-handling information: “had Stage IV; and 7% received prior systemic cytotoxic chemotherapy as neoadjuvant or adjuvant therapy. With regard to EGFR tumor testing, 63% were exon 19 deletions and 37%”
Supporting onlyCarcinogenicity: “MATE1, MATE2K and OCT2. 13 13.1 A 2-year carcinogenicity was conducted in male and female rats at oral osimertinib doses of 1, 3, and 10 mg/kg/day. Osimertinib increased t”
NegatedGenotoxicity / mutagenicity: “reverse mutation (Ames) assay and was not genotoxic in mouse lymphoma cells or in the rat in vivo micronucleus assay. Based on studies in animals, male fertility may be”
NegatedGenotoxicity / mutagenicity: “in mouse lymphoma cells or in the rat in vivo micronucleus assay. Based on studies in animals, male fertility may be impaired by treatment with TAGRISSO. Degenerative changes wer”
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.