Lunsumio (MOSUNETUZUMAB): 1 of 6 NIOSH criteria in the label

Screening report

Genentech, Inc. · Package insert of record

Lunsumio (MOSUNETUZUMAB)

Not on the NIOSH ListDailyMed

Developmental / reproductive language

The label notes developmental and/or reproductive toxicity. Many drugs carry this language and are not classified as hazardous.

1 / 6NIOSH hazard criteria present in this label

Special handling

Carcinogenicity

Developmental

Reproductive

Genotoxicity

Organ toxicity

Developmental / embryo-fetal toxicity

14 passages in the label

“…dispensed, and administered. ( 5.7 ) Embryo-Fetal Toxicity : May cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use…”

2 more passages

“…LUNSUMIO for or with LUNSUMIO VELO. 5.8 Embryo-Fetal Toxicity Based on its mechanism of action, LUNSUMIO may cause fetal harm when administered to a pregnant woman. Advise…”

“…[see Warnings and Precautions (5.6) ]. Embryo-Fetal Toxicity - Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to inform t…”

Drug-class hint

Context only · not counted

“…an anti-CD20 monoclonal antibody and an alkylating agent. Patients received step-up doses of 1 mg on Cycle 1 Day 1 and 2 mg on Cycle 1 Day 8, followed by 60 mg on Cycle 1 Day 1…”

Set aside: found but not counted (4)

NegatedCarcinogenicity: “could not be assessed. 13 13.1 No carcinogenicity or genotoxicity studies have been conducted with mosunetuzumab-axgb. No dedicated studies have been conducted to e”

Supporting onlyCarcinogenicity: “in GO29781 in 218 patients with hematologic malignancies in an open-label, multicenter, multi-cohort study. Patients received step-up doses of 1 mg on Cycle 1 Day 1 and 2 mg on”

NegatedGenotoxicity / mutagenicity: “be assessed. 13 13.1 No carcinogenicity or genotoxicity studies have been conducted with mosunetuzumab-axgb. No dedicated studies have been conducted to evaluate the effe”

NegatedDevelopmental / embryo-fetal toxicity: “drug-associated risk. No animal reproductive or developmental toxicity studies have been conducted with mosunetuzumab-axgb. Mosunetuzumab-axgb causes T-cell activation and cytokine release;”

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.