Screening report

Rigel Pharmaceuticals, Inc. · Package insert of record

Gavreto (PRALSETINIB)

Not on the NIOSH ListDailyMed (opens the full label on DailyMed in a new tab)
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: not found
Carcinogenicity: not found
Developmental: present in the label
Reproductive: present in the label
Genotoxicity: not found
Organ toxicity: present in the label
Developmental / embryo-fetal toxicity
21 passages in the label

“…complications has not been established. ( 5.7 ) Embryo-Fetal Toxicity : Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use e…”

2 more passages

“…complications has not been established. 5.8 Embryo-Fetal Toxicity Based on findings from animal studies and its mechanism of action, GAVRETO can cause fetal harm when administe…”

“…risk to a fetus. Data Animal Data In an embryo-fetal development study, once daily oral administration of pralsetinib to pregnant rats during the period of organogenesis re…”

Reproductive / fertility toxicity
4 passages in the label

“…of reproductive potential that GAVRETO may impair fertility [See (8.3) ]. Drug Interactions Advise patients and caregivers to inform their healthcare provider of all concomitant…”

2 more passages

“…for 1 week after the last dose [see (8.2) ]. Infertility Advise males and females of reproductive potential that GAVRETO may impair fertility [See (8.3) ]. Drug Interactions…”

Animal study“…treated and mated to each other, GAVRETO may impair fertility [see (13.1) ]. 8.4 Pediatric Use The safety and effectiveness of GAVRETO have been established in pediatric patients…”

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

“…is controlled. Grade 4 Discontinue GAVRETO. Hepatotoxicity [see Warnings and Precautions (5.4) ] Grade 3 or 4 Withhold GAVRETO and monitor AST/ALT once weekly until resolution…”

2 more passages

“…GAVRETO based on severity. ( 2.3 , 5.3 ) Hepatotoxicity : Monitor ALT and AST prior to initiating GAVRETO, every 2 weeks during the first 3 months, then monthly thereafter…”

“…[see Dosage and Administration (2.3) ] . 5.4 Hepatotoxicity Serious hepatic adverse reactions occurred in 1.5% of patients treated with GAVRETO. Increased AST occurred in 49% o…”

Drug-class hint
Context only · not counted

“…RET fusion-positive NSCLC who had progressed on platinum-based chemotherapy and treatment-naïve patients with metastatic NSCLC. Identification of a RET gene fusion was determined by…”

Set aside: found but not counted (6)
NegatedCarcinogenicity: “clinically relevant concentrations. 13 13.1 Carcinogenicity studies with pralsetinib have not been conducted. Pralsetinib was not mutagenic in an in vitro bacterial reverse m”
Supporting onlyCarcinogenicity: “and activating point mutations can drive tumorigenic potential through hyperactivation of downstream signaling pathways leading to uncontrolled cell proliferation. Pralse”
NegatedGenotoxicity / mutagenicity: “have not been conducted. Pralsetinib was not mutagenic in an in vitro bacterial reverse mutation (Ames) assay with or without metabolic activation and was not clastogenic i”
NegatedGenotoxicity / mutagenicity: “or without metabolic activation and was not clastogenic in either an in vitro micronucleus assay in TK6 cells or an in vivo bone marrow micronucleus assay in rats. In a dedi”
NegatedGenotoxicity / mutagenicity: “and was not clastogenic in either an in vitro micronucleus assay in TK6 cells or an in vivo bone marrow micronucleus assay in rats. In a dedicated fertility and early embryonic d”
NegatedGenotoxicity / mutagenicity: “assay in TK6 cells or an in vivo bone marrow micronucleus assay in rats. In a dedicated fertility and early embryonic development study conducted in treated male rats mated to t”
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.