Columvi (GLOFITAMAB): 1 of 6 NIOSH criteria in the label

Screening report

Genentech, Inc. · Package insert of record

Columvi (GLOFITAMAB)

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

“…risk for complications of tumor flare. ( 5.4 ) 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

“…[see Dosage and Administration (2.4) ] . 5.5 Embryo-Fetal Toxicity Based on its mechanism of action, COLUMVI may cause fetal harm when administered to a pregnant woman. Advise p…”

“…[see Warnings and Precautions (5.4) ] . Embryo-Fetal Toxicity Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to inform the…”

Set aside: found but not counted (3)

NegatedCarcinogenicity: “of glofitamab-gxbm is unknown. 13 13.1 No carcinogenicity or genotoxicity studies have been conducted with glofitamab-gxbm. Fertility studies have not been conducted with g”

NegatedGenotoxicity / mutagenicity: “is unknown. 13 13.1 No carcinogenicity or genotoxicity studies have been conducted with glofitamab-gxbm. Fertility studies have not been conducted with glofitamab-gxbm.”

NegatedDevelopmental / embryo-fetal toxicity: “risk. No animal reproductive and developmental toxicity studies have been conducted with glofitamab-gxbm. Glofitamab-gxbm causes T-cell activation and cytokine release; immune”

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.