Screening report

U.S. Pharmaceuticals · Package insert of record

Talzenna (TALAZOPARIB)

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.
5 / 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: present in the label
Organ toxicity: present in the label
Carcinogenicity
8 passages in the label

“…AND PRECAUTIONS • Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML) : MDS/AML occurred in patients exposed to TALZENNA, and some cases were fatal. Monitor patients for hematolog…”

2 more passages

“…5.3 , 8.1 , 8.3 ) 5.1 Myelodysplastic Syndrome/Acute Myeloid Leukemia Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML), including cases with a fatal outcome, has been reported in p…”

“…Myeloid Leukemia Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML), including cases with a fatal outcome, has been reported in patients who received TALZENNA. Overall, MDS/AML…”

Genotoxicity / mutagenicity
7 passages in the label

“…conducted with talazoparib. Talazoparib was clastogenic in an in vitro chromosomal aberration assay in human peripheral blood lymphocytes and in an in vivo bone marrow micro…”

2 more passages

“…the last dose of TALZENNA. Males Based on genotoxicity and animal reproduction studies, advise male patients with female partners of reproductive potential and pregnant…”

“…of talazoparib, indicating the potential for genotoxicity in humans. Talazoparib was not mutagenic in a bacterial reverse mutation (Ames) test. Fertility studies in animals…”

Developmental / embryo-fetal toxicity
27 passages in the label

“…neutropenia, and/or thrombocytopenia. ( 5.2 ) • Embryo-Fetal Toxicity : TALZENNA can cause fetal harm. Advise of the potential risk to the fetus and to use effective contraception.…”

2 more passages

“…[see Dosage and Administration (2.5) ] . 5.3 Embryo-Fetal Toxicity Based on its mechanism of action and findings from animal data, TALZENNA can cause fetal harm when administere…”

“…and structural skeletal variations, and embryo-fetal death at exposures that were 0.24 times the area under the concentration-time curve (AUC) in patients receiving the rec…”

Reproductive / fertility toxicity
2 passages in the label
Animal data

“…Males Based on animal studies, TALZENNA may impair fertility in males of reproductive potential [see (13.1) ]. 8.4 Pediatric Use The safety and effectiveness of TALZENNA have not…”

1 more passage

“…the last dose [see (8.1) , (13.1) ] . Infertility Males Based on animal studies, TALZENNA may impair fertility in males of reproductive potential [see (13.1) ]. 8.4 Pe…”

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

“…discontinue if MDS/AML is confirmed. ( 5.1 ) • Myelosuppression : TALZENNA may affect hematopoiesis and can cause anemia, neutropenia, and/or thrombocytopenia. ( 5.2 ) • Embryo-Fetal…”

2 more passages

“…MDS/AML is confirmed, discontinue TALZENNA. 5.2 Myelosuppression Myelosuppression consisting of anemia, neutropenia, and/or thrombocytopenia, have been reported in patients treated wit…”

“…discontinue TALZENNA. 5.2 Myelosuppression Myelosuppression consisting of anemia, neutropenia, and/or thrombocytopenia, have been reported in patients treated with TALZENNA [see A…”

Drug-class hint
Context only · not counted

“…treatment with an anthracycline and/or a taxane (unless contraindicated) in the neoadjuvant, adjuvant, and/or metastatic treatment setting. First-line treatment for ad…”

Set aside: found but not counted (3)
Supporting onlyManufacturer special-handling information: “and BRCA2 , have shown that talazoparib-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complexes resulting in DNA dam”
NegatedCarcinogenicity: “1A4, 1A6, 1A9, 2B7, and 2B15). 13 13.1 Carcinogenicity studies have not been conducted with talazoparib. Talazoparib was clastogenic in an in vitro chromosomal aberratio”
NegatedGenotoxicity / mutagenicity: “for genotoxicity in humans. Talazoparib was not mutagenic in a bacterial reverse mutation (Ames) test. Fertility studies in animals have not been conducted with talazoparib. I”
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.