Screening report

ImmunoGen, Inc. · Package insert of record

ELAHERE (MIRVETUXIMAB SORAVTANSINE)

NIOSH Table 1DailyMed (opens the full label on DailyMed in a new tab)
On the NIOSH List — Table 1
This drug appears on the NIOSH List of Hazardous Drugs, 2024 (Table 1).
4 / 6NIOSH hazard criteria present in this label
Special handling: present in the label
Carcinogenicity: not found
Developmental: present in the label
Reproductive: not found
Genotoxicity: present in the label
Organ toxicity: present in the label
Manufacturer special-handling information
9 passages in the label

“…and Administration Preparation ELAHERE is a hazardous drug. Follow applicable special handling and disposal procedures 1 . Calculate the dose (mg) (based on the patient’s AIBW),…”

2 more passages

“…Survival in Study 0416 15 REFERENCES 1 “OSHA Hazardous Drugs.” OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html 16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Each ELAH…”

“…vial. Discard unused portion Warning: Hazardous Drug Dispense the enclosed Medication Guide to each patient. abbvie NDC: 72903-853-01 Rx Only ELAHERE® mirvetuximab soravtan…”

Genotoxicity / mutagenicity
5 passages in the label

“…to a pregnant woman because it contains a genotoxic compound (DM4) and affects actively dividing cells. Advise pregnant women of the potential risk to a fetus. Advise fe…”

2 more passages

“…to a pregnant woman because it contains a genotoxic compound (DM4) and affects actively dividing cells [see Clinical Pharmacology ( 12.1 ), ( 13.1 )] . Human immunoglo…”

“…ELAHERE, DM4, disrupts microtubule function, is genotoxic, and can be toxic to actively dividing cells, suggesting it has the potential to cause embryotoxicity and teratogenic…”

Developmental / embryo-fetal toxicity
14 passages in the label

“…has the potential to cause embryotoxicity and teratogenicity. 8.2 Lactation Risk Summary There are no data on the presence of mirvetuximab soravtansine-gynx in human milk or t…”

2 more passages

“…of peripheral neuropathy. ( 2.4 , 5.3 ) Embryo-Fetal Toxicity: ELAHERE can cause fetal harm. Advise of the potential risk to a fetus and to use effective contraception. ( 5…”

“…[see Dosage and Administration ( 2.4 )]. 5.4 Embryo-Fetal Toxicity Based on its mechanism of action, ELAHERE can cause embryo-fetal harm when administered to a pregnant woman be…”

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

“…Pneumonitis Severe, life-threatening, or fatal interstitial lung disease (ILD), including pneumonitis, can occur in patients treated with ELAHERE. Pneumonitis occurred in 10% of patients treat…”

2 more passages

“…>1 peripheral neuropathy, or noninfectious interstitial lung disease. Patients were randomized (1:1) to receive ELAHERE 6 mg/kg (based on adjusted ideal body weight) as an intravenous infu…”

“…>1 peripheral neuropathy, or noninfectious interstitial lung disease. Patients received ELAHERE 6 mg/kg (based on adjusted ideal body weight) as an intravenous infusion every 3 weeks until…”

Drug-class hint
Context only · not counted

“…is a folate receptor alpha (FRα)-directed antibody-drug conjugate (ADC) consisting of three components: 1) an anti-FRα monoclonal antibody of IgG1 subtype 2) the small molecule anti-tub…”

Set aside: found but not counted (2)
NegatedCarcinogenicity: “compared to ADA-negative patients. 13 13.1 Carcinogenicity studies have not been conducted with mirvetuximab soravtansine-gynx or DM4. DM4 and the metabolite, S-methyl DM4,”
NegatedGenotoxicity / mutagenicity: “study. DM4 and S-methyl DM4 were not mutagenic in the bacterial reverse mutation (Ames) assay. Fertility studies have not been conducted with mirvetuximab soravtans”
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.