KEYTRUDA QLEX (PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH): 2 of 6 NIOSH criteria in the label

Screening report

Merck Sharp & Dohme LLC · Package insert of record

KEYTRUDA QLEX (PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH)

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.

2 / 6NIOSH hazard criteria present in this label

Special handling

Carcinogenicity

Developmental

Reproductive

Genotoxicity

Organ toxicity

Developmental / embryo-fetal toxicity

18 passages in the label

“…outside of controlled clinical trials. ( 5.4 ) Embryo-Fetal toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use ef…”

2 more passages

“…recommended outside of controlled trials. 5.5 Embryo-Fetal Toxicity Based on its mechanism of action, KEYTRUDA QLEX can cause fetal harm when administered to a pregnant woman. An…”

“…immune response. Berahyaluronidase alfa: In an embryo-fetal development study, pregnant rabbits were administered daily subcutaneous injections of 138,600, 403,200, or 1,209,600 U…”

Organ toxicity (verify at low doses)

98 passages in the label

“…Colitis resolved in 85% of the 48 patients. Hepatotoxicity and Immune-Mediated Hepatitis KEYTRUDA QLEX can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred…”

2 more passages

“…: diarrhea, fatigue/asthenia, hypertension, hepatotoxicity, hypothyroidism, decreased appetite, palmar-plantar erythrodysesthesia, nausea, stomatitis/mucosal inflammation, dys…”

“…erythrodysesthesia, dysphonia, rash, hepatotoxicity, and acute kidney injury. in combination with belzutifan (reported in ≥25%) : decreased hemoglobin, increased alanin…”

Drug-class hint

Context only · not counted

“…NSCLC: carboplatin AUC 6 mg/mL/min and a taxane (paclitaxel 200 mg/m 2 on Day 1 of each 21-day cycle or paclitaxel protein-bound 100 mg/m 2 on Days 1, 8 and 15 of each…”

Set aside: found but not counted (10)

Supporting onlyManufacturer special-handling information: “macrophages, increased activated cytotoxic T cells, and reduced tumor growth compared to either treatment alone. Berahyaluronidase alfa, an endoglycosidase, is a”

NegatedCarcinogenicity: “to test the potential of pembrolizumab for carcinogenicity or genotoxicity. Fertility studies have not been conducted with pembrolizumab. In 1-month and 6-month repeat-dose”

NegatedCarcinogenicity: “studies have not been performed to assess the carcinogenic or mutagenic potential of berahyaluronidase alfa. In a fertility and early embryonic development study, male and fema”

Supporting onlyCarcinogenicity: “surgery, local or distant recurrence, second primary malignancy, or death due to any cause. An additional efficacy outcome was overall survival (OS). The study population characteri”

NegatedGenotoxicity / mutagenicity: “been performed to assess the carcinogenic or mutagenic potential of berahyaluronidase alfa. In a fertility and early embryonic development study, male and female rats were”

NegatedGenotoxicity / mutagenicity: “of pembrolizumab for carcinogenicity or genotoxicity. Fertility studies have not been conducted with pembrolizumab. In 1-month and 6-month repeat-dose toxicology studi”

NegatedDevelopmental / embryo-fetal toxicity: “no available human data informing the risk of embryo-fetal toxicity. In animal models, the PD-1/PD-L1 signaling pathway is important in the maintenance of pregnancy through induc”

NegatedDevelopmental / embryo-fetal toxicity: “study in rats, there were no adverse embryo-fetal findings in pregnant animals administered daily subcutaneous injections of berahyaluronidase alfa at doses up to 2,520,”

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.