Screening report

Sobi, Inc. · Package insert of record

Vonjo (PACRITINIB)

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
1 passage in the label
Animal data

“…with an increased incidence of an external malformation (cleft palate) in the presence of maternal toxicity. In a pre- and post-natal development study in mice, pregnant anima…”

Reproductive / fertility toxicity
1 passage in the label
Animal data

“…8.3 Females and Males of Reproductive Potential Infertility Males Pacritinib reduced male mating and fertility indices in BALB/c mice [see ( 13.1 )]. Pacritinib may impair male…”

Organ toxicity (verify at low doses)
1 passage in the label

“…may lead to gastrointestinal toxicities, myelosuppression, blurred vision, dizziness, worsening performance status, and sepsis. There is no known antidote for overdose with VONJ…”

Set aside: found but not counted (12)
NegatedCarcinogenicity: “OAT1, or OAT3. 13 13.1 Pacritinib was not carcinogenic in the 6-month Tg.rasH2 transgenic mouse model. Pacritinib was not carcinogenic in a 2-year carcinogenicity study in”
NegatedCarcinogenicity: “transgenic mouse model. Pacritinib was not carcinogenic in a 2-year carcinogenicity study in rats at 0.004 times and 0.014 times, in males and females, respectively, the rec”
NegatedCarcinogenicity: “Pacritinib was not carcinogenic in a 2-year carcinogenicity study in rats at 0.004 times and 0.014 times, in males and females, respectively, the recommended human dose (AUC-”
NegatedCarcinogenicity: “evaluated and treated appropriately. 5.7 Secondary Malignancies Another JAK-inhibitor has increased the risk of lymphoma and other malignancies excluding non-melanoma skin cancer”
NegatedCarcinogenicity: “or PE [see Warnings and Precautions ( 5.6 )] . Secondary Malignancies Advise patients, especially current or past smokers and patients with a known secondary malignancy (other than a su”
NegatedCarcinogenicity: “or past smokers and patients with a known secondary malignancy (other than a successfully treated NMSC), that lymphoma and other malignancies (excluding NMSC) have been reported in”
NegatedCarcinogenicity: “Another JAK-inhibitor has increased the risk of lymphoma and other malignancies excluding non-melanoma skin cancer (NMSC) (compared to those treated with TNF blockers) in patie”
NegatedCarcinogenicity: “smokers and patients with a known secondary malignancy (other than a successfully treated NMSC), that lymphoma and other malignancies (excluding NMSC) have been reported in c”
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.