Screening report

AstraZeneca Pharmaceuticals LP · Package insert of record

CALQUENCE (ACALABRUTINIB)

Not on the NIOSH ListDailyMed (opens the full label on DailyMed in a new tab)
Carcinogenic / genotoxic findings in the label
The label reports carcinogenicity and/or genotoxicity findings — among the criteria NIOSH uses to identify hazardous drugs.
3 / 6NIOSH hazard criteria present in this label
Special handling: not found
Carcinogenicity: present in the label
Developmental: present in the label
Reproductive: not found
Genotoxicity: not found
Organ toxicity: present in the label
Carcinogenicity
19 passages in the label

“…[see Dosage and Administration (2.3) ] . 5.4 Second Primary Malignancies Second primary malignancies, including skin cancers and other solid tumors, occurred in 16% of 2,055 patients expos…”

2 more passages

“…(2.3) ] . 5.4 Second Primary Malignancies Second primary malignancies, including skin cancers and other solid tumors, occurred in 16% of 2,055 patients exposed to CALQUENCE in clinical…”

“…Adverse Reactions (6.1) ] . The most frequent second primary malignancy was non-melanoma skin cancer, reported in 9% of patients, followed by other solid tumors in 8% (including melanoma, l…”

Developmental / embryo-fetal toxicity
10 passages in the label

“…were confirmed in fetal rat plasma. In an embryo-fetal development study in rabbits, pregnant animals were administered acalabrutinib orally at doses up to 200 mg/kg/day duri…”

2 more passages

“…of Reproductive Potential CALQUENCE may cause embryo-fetal harm and dystocia when administered to pregnant women [see (8.1) ] . Pregnancy Testing Pregnancy testing is recommend…”

“…(2.2) ]. 8 • Pregnancy: May cause fetal harm and dystocia. ( 8.1 ) • Lactation: Advise not to breastfeed. ( 8.2 ) • Severe Hepatic Impairment: Avoid use of CALQUENC…”

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

“…symptoms of arrhythmias and manage. ( 5.5 ) • Hepatotoxicity, Including Drug Induced Liver Injury: Monitor hepatic function throughout treatment. ( 5.6 ) 5.1 Serious and Opportu…”

2 more passages

“…dyspnea) and manage as appropriate. 5.6 Hepatotoxicity, Including Drug-Induced Liver Injury Hepatotoxicity, including severe, life-threatening, and potentially fatal cases…”

“…Including Drug-Induced Liver Injury Hepatotoxicity, including severe, life-threatening, and potentially fatal cases of drug-induced liver injury (DILI), has occurred i…”

Set aside: found but not counted (6)
NegatedCarcinogenicity: “a substrate of OATP1B1 or OATP1B3. 13 13.1 Carcinogenicity studies have not been conducted with acalabrutinib. Acalabrutinib was not mutagenic in an in vitro bacterial rever”
NegatedGenotoxicity / mutagenicity: “with acalabrutinib. Acalabrutinib was not mutagenic in an in vitro bacterial reverse mutation (AMES) assay or clastogenic in an in vitro human lymphocyte chromosomal abe”
NegatedGenotoxicity / mutagenicity: “bacterial reverse mutation (AMES) assay or clastogenic in an in vitro human lymphocyte chromosomal aberration assay or in an in vivo rat bone marrow micronucleus assay. In”
NegatedGenotoxicity / mutagenicity: “or clastogenic in an in vitro human lymphocyte chromosomal aberration assay or in an in vivo rat bone marrow micronucleus assay. In a fertility study in rats, there were no effects of acala”
NegatedGenotoxicity / mutagenicity: “assay or in an in vivo rat bone marrow micronucleus assay. In a fertility study in rats, there were no effects of acalabrutinib on fertility in male rats at exposures 11 t”
NegatedDevelopmental / embryo-fetal toxicity: “through gestational day [GD] 17. No effects on embryo-fetal development and survival were observed. The AUC at 200 mg/kg/day in pregnant rats was approximately 9 times the AUC in”
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.