WELIREG (belzutifan): 3 of 6 NIOSH criteria in the label

Screening report

Merck Sharp & Dohme LLC · Package insert of record

WELIREG (belzutifan)

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.

3 / 6NIOSH hazard criteria present in this label

Special handling

Carcinogenicity

Developmental

Reproductive

Genotoxicity

Organ toxicity

Developmental / embryo-fetal toxicity

22 passages in the label

“…UNSPECIFIED TALC TITANIUM DIOXIDE 177 WARNING: EMBRYO-FETAL TOXICITY Exposure to WELIREG during pregnancy can cause embryo-fetal harm. Verify pregnancy status prior to the initiat…”

2 more passages

“…Exposure to WELIREG during pregnancy can cause embryo-fetal harm. Verify pregnancy status prior to the initiation of WELIREG. Advise patients of these risks and the need for effec…”

“…Interactions (7.2) , (8.1 , 8.3) ]. WARNING: EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. Exposure to WELIREG during pregnancy can cause em…”

Reproductive / fertility toxicity

7 passages in the label

“…not to breastfeed. ( 8.2 ) Infertility : May impair fertility in males and females. ( 8.3 ) 8.1 Pregnancy Risk Summary Refer to the Prescribing Information of the individual therape…”

2 more passages

“…male and female patients that WELIREG may impair fertility [see (8.3) ] . Dosage and Administration Instruct patients to take their dose of WELIREG at the same time each day (o…”

“…Lactation : Advise not to breastfeed. ( 8.2 ) Infertility : May impair fertility in males and females. ( 8.3 ) 8.1 Pregnancy Risk Summary Refer to the Prescribing Information of…”

Organ toxicity (verify at low doses)

1 passage in the label

“…left ventricular ejection fraction (LVEF), and cardiomyopathy, can occur with WELIREG in combination with lenvatinib. The safety of WELIREG in combination with lenvatinib has not be…”

Set aside: found but not counted (7)

NegatedCarcinogenicity: “and CYP2C19 poor metabolizers. 13 13.1 Carcinogenesis No carcinogenic risk was identified with belzutifan in a 6-month transgenic rasH2 mouse study with oral administrat”

NegatedCarcinogenicity: “metabolizers. 13 13.1 Carcinogenesis No carcinogenic risk was identified with belzutifan in a 6-month transgenic rasH2 mouse study with oral administration up to 600 mg/k”

NegatedGenotoxicity / mutagenicity: “exposure at the recommended dose based on AUC). Mutagenesis Belzutifan was not mutagenic in the in vitro bacterial reverse mutation (Ames) assay. Belzutifan was not clastogeni”

NegatedGenotoxicity / mutagenicity: “based on AUC). Mutagenesis Belzutifan was not mutagenic in the in vitro bacterial reverse mutation (Ames) assay. Belzutifan was not clastogenic in either an in vitro micronu”

NegatedGenotoxicity / mutagenicity: “mutation (Ames) assay. Belzutifan was not clastogenic in either an in vitro micronucleus assay or an in vivo rat bone marrow micronucleus assay. Fertility studies in ani”

NegatedGenotoxicity / mutagenicity: “was not clastogenic in either an in vitro micronucleus assay or an in vivo rat bone marrow micronucleus assay. Fertility studies in animals have not been conducted with bel”

NegatedGenotoxicity / mutagenicity: “assay or an in vivo rat bone marrow micronucleus assay. Fertility studies in animals have not been conducted with belzutifan. In repeat-dose toxicity studies up to 3-”

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.