Screening report

Jazz Pharmaceuticals, Inc. · Package insert of record

Rylaze (ASPARAGINASE ERWINIA CHRYSANTHEMI (RECOMBINANT)-RYWN)

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.
2 / 6NIOSH hazard criteria present in this label
Special handling: not found
Carcinogenicity: not found
Developmental: present in the label
Reproductive: not found
Genotoxicity: not found
Organ toxicity: present in the label
Developmental / embryo-fetal toxicity
7 passages in the label

“…resulted in structural abnormalities and embryo-fetal mortality ( see Data ) at exposures below those in patients at the recommended human dose. Advise pregnant women of the…”

2 more passages

“…studies have not been conducted with RYLAZE. In embryofetal development studies, asparaginase Erwinia chrysanthemi was administered intramuscularly every other day during the peri…”

“…animal reproduction studies, RYLAZE can cause fetal harm when administered to a pregnant woman. There are no available data on RYLAZE use in pregnant women to evaluate for a dr…”

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

“…next scheduled dose if bleeding is controlled. Hepatotoxicity [see Warnings and Precautions ( 5.5 )] Total bilirubin > 3 times to ≤ 10 times the ULN • Hold RYLAZE until total bil…”

2 more passages

“…or life-threatening hemorrhage. ( 5.4 ) • Hepatotoxicity, including hepatic veno-occlusive disease: Discontinue RYLAZE for grade 4 increases of bilirubin. ( 5.5 ) 5.1 Hypers…”

“…[see Dosage and Administration ( 2.3 )] . 5.5 Hepatotoxicity, including Hepatic Veno-Occlusive Disease Elevated bilirubin and/or transaminases occurred in 75% of patients treate…”

Set aside: found but not counted (4)
NegatedCarcinogenicity: “not been adequately characterized. 13 13.1 Carcinogenicity, mutagenicity, and studies have not been conducted with asparaginase erwinia chrysanthemi (recombinant)-rywn. In”
NegatedGenotoxicity / mutagenicity: “characterized. 13 13.1 Carcinogenicity, mutagenicity, and studies have not been conducted with asparaginase erwinia chrysanthemi (recombinant)-rywn. In a fertility a”
NegatedDevelopmental / embryo-fetal toxicity: “Data Animal Data Animal reproductive and developmental toxicity studies have not been conducted with RYLAZE. In embryofetal development studies, asparaginase Erwinia chrysanthemi was”
NegatedDevelopmental / embryo-fetal toxicity: “to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproductive and developmental toxicity studies, intram”
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.