Screening report

Advanced Accelerator Applications USA, Inc · Package insert of record

Lutathera (LUTETIUM LU 177 DOTATATE)

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
12 passages in the label

“…Lu 177 dotatate; however, radiation is a carcinogen and mutagen. No animal studies were conducted to determine the effects of lutetium Lu 177 dotatate on fertility. 13.2 A…”

2 more passages

“…(2.0%) developed MDS and 4 (0.5%) developed acute leukemia. The median time to onset was 29 months (9 to 45 months) for MDS and 55 months (32 to 125 months) for acute leukemia. 5…”

“…and Administration ( 2.4 )] . 5.3 Secondary Myelodysplastic Syndrome and Leukemia In NETTER-1, with a median follow-up time of 76 months in the main study, myelodysplastic syndrome (MDS) w…”

Genotoxicity / mutagenicity
1 passage in the label

“…however, radiation is a carcinogen and mutagen. No animal studies were conducted to determine the effects of lutetium Lu 177 dotatate on fertility. 13.2 Animal Toxico…”

Developmental / embryo-fetal toxicity
16 passages in the label

“…or other signs and symptoms. ( 5.7 ) Embryo-Fetal Toxicity : Can cause fetal harm. Advise females and males of reproductive potential of the potential risk to a fetus an…”

2 more passages

“…and electrolytes as indicated. 5.8 Embryo-Fetal Toxicity Based on its mechanism of action, LUTATHERA can cause fetal harm when administered to a pregnant woman [see Cl…”

“…[see Warnings and Precautions ( 5.7 )] . Embryo-Fetal Toxicity Advise pregnant women and males and females of reproductive potential of the potential risk to a fetus. Advise…”

Reproductive / fertility toxicity
8 passages in the label

“…female and male patients that LUTATHERA may impair fertility [see Warnings and Precautions ( 5.9 ), ( 8.3 )] . Distributed by: Advanced Accelerator Applications USA, Inc., Millbu…”

2 more passages

“…contraception. ( 5.8 , 8.1 , 8.3 ) Risk of Infertility : LUTATHERA may cause infertility. ( 5.9 , 8.3 ) 5.1 Risk From Radiation Exposure LUTATHERA contributes to a patient’s…”

“…8.3 ) Risk of Infertility : LUTATHERA may cause infertility. ( 5.9 , 8.3 ) 5.1 Risk From Radiation Exposure LUTATHERA contributes to a patient’s overall long-term cumulative radia…”

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

“…toxicity Permanently discontinue LUTATHERA. Hepatotoxicity [see Warnings and Precautions ( 5.5 )] First occurrence of: Bilirubinemia greater than 3 times the upper limit of no…”

2 more passages

“…dose. Permanently discontinue LUTATHERA for hepatotoxicity requiring a dosing interval beyond 16 weeks. Recurrent hepatotoxicity Permanently discontinue LUTATHERA. Hypersensit…”

“…a dosing interval beyond 16 weeks. Recurrent hepatotoxicity Permanently discontinue LUTATHERA. Hypersensitivity Reactions b [see Warnings and Precautions ( 5.6 )] First occurre…”

Set aside: found but not counted (4)
NegatedCarcinogenicity: “OCT2, OATP1B1, or OATP1B3 in vitro. 13 13.1 Carcinogenicity and mutagenicity studies have not been conducted with lutetium Lu 177 dotatate; however, radiation is a carcinogen”
NegatedGenotoxicity / mutagenicity: “in vitro. 13 13.1 Carcinogenicity and mutagenicity studies have not been conducted with lutetium Lu 177 dotatate; however, radiation is a carcinogen and mutagen. No”
NegatedDevelopmental / embryo-fetal toxicity: “evaluate its effect on female reproduction and embryo-fetal development; however, radioactive emissions, including those from LUTATHERA, can cause fetal harm. Verify pregnancy sta”
NegatedOrgan toxicity (verify at low doses): “If reduced LUTATHERA dose does not result in hepatotoxicity, administer LUTATHERA at 7.4 GBq (200 mCi) as next dose. Permanently discontinue LUTATHERA for hepatotoxicity requir”
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.