Screening report

Genentech, Inc. · Package insert of record

ALECENSA (ALECTINIB HYDROCHLORIDE)

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: not found
Developmental: present in the label
Reproductive: not found
Genotoxicity: present in the label
Organ toxicity: present in the label
Genotoxicity / mutagenicity
2 passages in the label

“…the last dose [see (8.1) ] . Males Based on genotoxicity findings, advise males with female partners of reproductive potential to use effective contraception during treatm…”

1 more passage

Animal study“…number of micronuclei in a rat bone marrow micronucleus test. The mechanism of micronucleus induction was abnormal chromosome segregation (aneugenicity) and not a clastogenic…”

Developmental / embryo-fetal toxicity
21 passages in the label

“…ALECENSA based on severity. ( 2.4 , 5.7 ) Embryo-Fetal Toxicity: ALECENSA can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and…”

2 more passages

“…[see Dosage and Administration (2.4) ]. 5.8 Embryo-Fetal Toxicity Based on findings from animal studies and its mechanism of action, ALECENSA can cause fetal harm when administ…”

“…during the period of organogenesis resulted in embryo-fetal toxicity and abortion at maternally toxic doses with exposures approximately 2.7-fold those observed in humans with ale…”

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

“…None. None. ( 4 ) 5 WARNINGS AND PRECAUTIONS Hepatotoxicity: Monitor liver laboratory tests every 2 weeks during the first 3 months of treatment, then once a month and as clini…”

2 more passages

“…contraception. ( 5.8 , 8.1 , 8.3 ) 5.1 Hepatotoxicity Severe hepatotoxicity, including drug-induced liver injury, occurred in patients treated with ALECENSA. In the poole…”

“…( 5.8 , 8.1 , 8.3 ) 5.1 Hepatotoxicity Severe hepatotoxicity, including drug-induced liver injury, occurred in patients treated with ALECENSA. In the pooled safety population [s…”

Drug-class hint
Context only · not counted

“…was 23.9 months for ALECENSA and 2.1 months for platinum-based chemotherapy. Serious adverse reactions occurred in 13% of patients treated with ALECENSA; the most frequent serious ad…”

Set aside: found but not counted (7)
NegatedCarcinogenicity: “OCT2 transport activity in vitro. 13 13.1 Carcinogenicity studies with alectinib have not been conducted. Alectinib was not mutagenic in vitro in the bacterial reverse muta”
NegatedGenotoxicity / mutagenicity: “have not been conducted. Alectinib was not mutagenic in vitro in the bacterial reverse mutation (Ames) assay, but was positive with an increased number of micronuclei in”
NegatedGenotoxicity / mutagenicity: “chromosome segregation (aneugenicity) and not a clastogenic effect on chromosomes. No studies in animals have been performed to evaluate the effect of alectinib on fertility. No”
NegatedGenotoxicity / mutagenicity: “bone marrow micronucleus test. The mechanism of micronucleus induction was abnormal chromosome segregation (aneugenicity) and not a clastogenic effect on chromosomes. No studies in”
NegatedGenotoxicity / mutagenicity: “induction was abnormal chromosome segregation (aneugenicity) and not a clastogenic effect on chromosomes. No studies in animals have been performed to evaluate the effect of”
NegatedOrgan toxicity (verify at low doses): “discontinue if no other potential causes of ILD/pneumonitis have been identified. ( 2.4 , 5.2 ) Renal Impairment: Withhold ALECENSA for severe renal impairment, then resume ALECEN”
NegatedOrgan toxicity (verify at low doses): “ALECENSA if no other potential causes of ILD/pneumonitis have been identified [see Dosage and Administration (2.4) and Adverse Reactions (6) ] . 5.3 Renal Impairment Renal impa”
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.