Screening report

Novartis Pharmaceuticals Corporation · Package insert of record

PLUVICTO (LUTETIUM LU 177 VIPIVOTIDE TETRAXETAN)

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
1 passage in the label

“…vipivotide tetraxetan; however, radiation is a carcinogen and mutagen. No animal studies were conducted to determine the effects of lutetium Lu 177 vipivotide tetraxetan on fert…”

Genotoxicity / mutagenicity
2 passages in the label

“…however, radiation is a carcinogen and mutagen. No animal studies were conducted to determine the effects of lutetium Lu 177 vipivotide tetraxetan on fertility. 14 CL…”

1 more passage

“…as well as to surrounding cells, and induces DNA damage which can lead to cell death. 12.2 Pharmacodynamics Lutetium Lu 177 vipivotide tetraxetan exposure-efficacy relationshi…”

Developmental / embryo-fetal toxicity
14 passages in the label

“…PLUVICTO based on severity. ( 2.4 , 5.3 ) Embryo-Fetal Toxicity : Can cause fetal harm. Advise males with female partners of reproductive potential to use effective contracep…”

2 more passages

“…usual [see Warnings and Precautions (5.3)] . Embryo-Fetal Toxicity Advise males that PLUVICTO can cause fetal harm [see Warnings and Precautions (5.4), (8.1)] . Advise male pa…”

“…( 2.4 , 5.3 ) Embryo-Fetal Toxicity : Can cause fetal harm. Advise males with female partners of reproductive potential to use effective contraception. ( 5.4 , 8.1 , 8.3 ) Infert…”

Reproductive / fertility toxicity
9 passages in the label

“…effective contraception. ( 5.4 , 8.1 , 8.3 ) Infertility : PLUVICTO may cause temporary or permanent infertility. ( 5.5 , 8.3 ) 5.1 Risk From Radiation Exposure PLUVICTO contri…”

2 more passages

“…: PLUVICTO may cause temporary or permanent infertility. ( 5.5 , 8.3 ) 5.1 Risk From Radiation Exposure PLUVICTO contributes to a patient’s overall long-term cumulative radiat…”

“…after the last dose [see (8.1, 8.3)] . 5.5 Infertility PLUVICTO may cause infertility in males. The recommended cumulative dose of 44.4 GBq of PLUVICTO results in a radiation…”

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

“…( 2.6 ) 4/2026 Warnings and Precautions, Myelosuppression ( 5.2 ) 7/2026 Warnings and Precautions, Renal Toxicity ( 5.3 ) 7/2026 1 INDICATIONS AND USAGE PLUVICTO is a radioligan…”

2 more passages

“…Adverse reaction Severity Dosage modification Myelosuppression (Anemia, thrombocytopenia, leukopenia, or neutropenia) [see Warnings and Precautions (5.2)] Grade 2 Withhold PLUVICTO u…”

“…20% to 5.9 GBq (160 mCi). Recurrent Grade ≥ 3 myelosuppression after one dose reduction Permanently discontinue PLUVICTO. Renal toxicity [see Warnings and Precautions (5.3)] Defined…”

Drug-class hint
Context only · not counted

“…and are considered appropriate to delay taxane-based chemotherapy, or have received prior taxane-based chemotherapy. ( 1.2 ) 1.1 Metastatic Androgen Pathway Modulatio…”

Set aside: found but not counted (7)
Supporting onlyManufacturer special-handling information: “continued until progressive disease, change of antineoplastic therapy, unacceptable toxicity, death, or withdrawal. The administered ARPI per investigator’s choice included abirater”
NegatedCarcinogenicity: “OATP1B3, OCT1 or OCT2 in vitro. 13 13.1 Carcinogenicity and mutagenicity studies have not been conducted with lutetium Lu 177 vipivotide tetraxetan; however, radiation is”
NegatedGenotoxicity / mutagenicity: “OCT2 in vitro. 13 13.1 Carcinogenicity and mutagenicity studies have not been conducted with lutetium Lu 177 vipivotide tetraxetan; however, radiation is a carcinogen and”
NegatedDevelopmental / embryo-fetal toxicity: “[see Dosage and Administration (2.4)] . 5.4 Embryo-Fetal Toxicity The safety and efficacy of PLUVICTO have not been established in females. Based on its mechanism of action, PL”
NegatedDevelopmental / embryo-fetal toxicity: “evaluate its effect on female reproduction and embryo-fetal development; however, radioactive emissions, including those from PLUVICTO, can cause fetal harm. Advise males with fem”
NegatedDevelopmental / embryo-fetal toxicity: “evaluate its effect on female reproduction and embryo-fetal development; however, all radioactive emissions, including those from PLUVICTO, can cause fetal harm. 8.2 Lactation Ris”
NegatedDevelopmental / embryo-fetal toxicity: “Dosage and Administration (2.4)] . 5.4 Embryo-Fetal Toxicity The safety and efficacy of PLUVICTO have not been established in females. Based on its mechanism of action, PLUVICTO ca”
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.