Screening report

pharmaand GmbH · Package insert of record

Rubraca (RUCAPARIB)

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.
3 / 6NIOSH hazard criteria present in this label
Special handling: not found
Carcinogenicity: present in the label
Developmental: present in the label
Reproductive: not found
Genotoxicity: present in the label
Organ toxicity: not found
Carcinogenicity
10 passages in the label

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

2 more passages

“…called ‘myelodysplastic syndrome’ (MDS) or ‘acute myeloid leukemia’ (AML) which have been reported in patients treated with RUBRACA [see Warnings and Precautions (5.1)]. Embryo-Fetal Tox…”

“…None. None. ( 4 ) 5 WARNINGS AND PRECAUTIONS Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): MDS/AML occurred in patients exposed to RUBRACA, and some cases were fatal. Monitor p…”

Genotoxicity / mutagenicity
5 passages in the label

“…been conducted with rucaparib. Rucaparib was clastogenic in an in vitro chromosomal aberration assay in cultured human lymphocytes. The clastogenic response in mitotically-st…”

2 more passages

“…of action of rucaparib and indicates potential genotoxicity in humans. Rucaparib was not mutagenic in a bacterial reverse mutation (Ames) test. Fertility studies with rucapar…”

“…assay in cultured human lymphocytes. The clastogenic response in mitotically-stimulated cells was anticipated based on the mechanism of action of rucaparib and indicates…”

Developmental / embryo-fetal toxicity
19 passages in the label

“…if MDS/AML is confirmed. ( 2.3 , 5.1 ) Embryo-Fetal Toxicity: RUBRACA can cause fetal harm. Advise of the potential risk to a fetus and to use effective contraception. ( 5…”

2 more passages

“…MDS/AML is confirmed, discontinue Rubraca. 5.2 Embryo-Fetal Toxicity Rubraca can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findin…”

“…during the period of organogenesis resulted in embryo-fetal death at exposures that were 0.04 times the AUC 0-24h in patients receiving the recommended human dose of 600 mg twice…”

Drug-class hint
Context only · not counted

“…therapy and who had not received treatment with taxane-based chemotherapy in the castration-resistant setting. [see Clinical Studies ( 14.2 )]. TRITON3 was a randomized, open…”

Set aside: found but not counted (3)
Supporting onlyManufacturer special-handling information: “vitro studies have shown that rucaparib-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complexes resulting in DNA dam”
NegatedCarcinogenicity: “not inhibit MRP2, MRP3, or BSEP. 13 13.1 Carcinogenicity studies have not been conducted with rucaparib. Rucaparib was clastogenic in an in vitro chromosomal aberration as”
NegatedGenotoxicity / mutagenicity: “genotoxicity in humans. Rucaparib was not mutagenic in a bacterial reverse mutation (Ames) test. Fertility studies with rucaparib have not been conducted. In 3-month rep”
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.