### NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2014: Proposed Additions and Deletions to the NIOSH Hazardous Drug List

The NIOSH Hazardous Drug Committee has reviewed all new FDA drug approvals and new drug warnings for the period since the first update to the list (January 2010 through December 2011. The committee reviewed 41 new drug approvals and 211 drugs with new warnings drugs and identified 45 drugs as potentially hazardous. Of these 45, 5 already have safe handling guidance in the drug package insert. Therefore, 40 drugs were identified for review by the expert panel.

Based on public comment and a reevaluation by the NIOSH Hazardous Drug Committee we are recommending that 27 drugs be added to the list in addition to the 5 with the manufacturers' safe handling guidelines for a total of 30 new drugs. Additionally, we are recommending that one drug be removed from the 2012 list.

We are requesting that, as members of the expert panel, you review the list of drugs that NIOSH suggests be added to the list and provide feedback on this list.

The recommendations of the peer reviewers and stakeholders are summarized below along with the NIOSH recommendation.

Pro osed Additions
Recommendations

Pstablished Name Peer ReviewerStakeholderNIOSH
abacavir 4/4 4/5 Abacavir will be listed on the 2014 hazardous drug list in a non-antineoplastic drug category based on malignant tumors in male and female mice and rats and genotoxicity
in vivo.

abiraterone 4/4 515 Abiraterone will be listed on the 2014 hazardous drug list as an antineoplastic drug. It is a Pregnancy Category X.

ado-trastuzumab emtansine NIOSH proposes to include ado-trastuzumab emtansine
on 20141ist based on manufacturer's recommendations for safe handling. It will be listed on the 2014 hazardous drug list as an antineoplastic drug. It is Pregnancy Category D.apomorphine 3/4 5/5 Apomorphine will be listed on the 2014 hazardous drug ]ist in a non-antineoplastic drug category based on its genotoxicity in several in vitro assays. asparaginase Erwinia Already on the list as "asparaginase". Asparaginase will chrysanthemi be deleted from the list.
bevacizumab 3/4 3/5 Bevacizumab will not be listed on the 2014 hazardous drug list. NIOSH had requested comments because of new warnings on this drug. NIOSH re-evaluated bevacizumab in light of new information on its bioavailability in the occupational setting provided by the
manufacturer and it was detennined that the new warnings were not suf6cient to warrant its listing.
brentuximab vedotin NIOSH proposes to include brentuximab vedotin on 2014
list based on manufacturer's recommendations for safe handling. It will be listed on the 2014 hazardous drug list as an antineoplastic drug. It is Pregnancy Category D.
cabazitaxel NIOSH proposes to include cabazitaxel on 2014 list
based on manufacturer's recommendations for safe handling. It will be listed on the 2014 hazardous drug list as an antineoplastic drug. It is Pregnancy Category D.
crizotinib 4/4 4/5 Crizotinib will be listed on the 2014 hazardous drug list as an antineoplastic drug and a Pregnancy Category D. deferiprone 4/4 5/5 Deferiprone will be listed on the 2014 hazardous drug list in a non-antineoplastic drug category based on genotoxicity in vitro and in vivo, and with additional recommendations about its reproductive risk. It is Pregnancy Category D.dexlansoprazole 2/4 1/5 Dexlansoprazole will not be listed on the 2014 hazardous drug list because it did not meet the NIOSH definition of a hazardous drug. Although some tumors were reported in laboratory studies, they were only seen at high does and the panel did not consider that there was sufficient evidence to list this drug. Following a final review, the expert panel concurred with not listing this drug as
hazardous.
dexmedetomidine 3/4 4/5 Initially, the expert panel recommended listing dexmedetomidine as a hazardous drug based on fetal toxicity in laboratory studies. The NIOSH Hazardous Drug Committee re-evaluated dexmedetomidine in light of new information provided by the manufacturer on the limited potential for occupational exposure and determined that it will not be listed for 2014. Following a final review, the expert panel concurred with not listing this drug as hazardous.
dexrazoxane NIOSH proposes to include dexrazoxane on 20141ist
based on manufacturer's recommendations for safe handling. It will be listed on the 2014 hazardous drug list as a non-antineoplastic drug with additional recommendations about its reproductive risk.
eribulin 4/4 5/5 Eribulin will be listed on the 2014 hazardous drug list as an antineo lastic drug and a pregnancy Category D.
erlotinib 4/4 3/5 Erlotinib will be listed on the 2014 hazardous drug list as an antineoplastic drug and a Pregnancy Category D.

### esomeprazole 2/4 2/5 Esomeprazole will not be listed on the 2014 hazardous drug list as it did not meet the NIOSI-I definition of a hazardous drug. Although some tuinors were reported in laboratory studies, they were only seen at high does and the panel did not consider that there was sufficient evidence to list this drug. Following a final review, the expert panel concun•ed with not listing this drug as
hazardous. ezogabine 3/4 2/5 Ezogabine was initially recommended as meeting the criteria for a hazardous drug based on adverse fetal effects. 1-Iowever, most effects on the fetus were associated with maternal toxicity. It was re-evaluated by the NIOSl-I 1-lazardous Drug Comniittee and it was
determined that it does not meet the criteria for a hazardous drug and v✓ill not be listed on the 2014 hazardous drug list. Following a final review, the expert anel concurred with not listing this drug as hazardous. fingolimod 3/4 5/5 Fingolimod will be listed on the 2014 hazardous drug list in a non-antineoplastic drug category based on malformations and embryo-fetal deaths at low doses and the observation of malignant lyniphomas in laboratory studies, and with additional recommendations about its
re roductive risk.
fluconazole 2/4 2/5 Fluconazole will be listed on the 2014 hazardous drug list with specific recommendations about its reproductive risk. Several ofthe reviewers who recommended against it being listed recommended that it be placed in a reproductive risk category.fosphenytoin 2/4 4/5 Fosphenytoin is metabolized to phenytoin which is also
listed as hazardous and is classified as IARC 2B. It willbe listed on the 2014 hazardous drug list in a nonantineoplastic drug category with additional reconmiendations about its reproductive risk. It is a 1'reganacy Category D. gabapentin 3/4 1/5 Gabapentin will not be listed on the 2014 hazardous drug
list as it did not meet the NIOSH definition of a hazardous drug. It produced some tumors in laboratory studies at very higb doses. Following a final review, the expert panel concurred with not listing this drug as
hazardous. gabapentin encarbil 2/4 2/5 Gabapentin encarbil will not be listed on the 2014 hazardous drug list as it did not meet the NIOSH definition a hazardous drug. lt produced some tuinors in laboratory studies at very high doses. Following a final review, the expert panel concurred witli not listing this drug as hazardous.
icatibant 3/4 4/5 Icatibant will be listed on the 2014 hazardous drug list with specific reconimendations about its reproductive
risk. lansoprazole 2/4 1/5 Lansoprazole will not be listed on the 2014 hazardous drug list as it did not meet the NIOSH definition of a hazardous drug. liraglutide recombinant 4/4 4/5 Liraglutide will be listed on the 2014 hazardous drug list in a non-antineoplastic drug category based on black box warning on thyroid tuntors in patients with supporting evidence in laboratory studies, and with additional
recommendations about its re roductive risk. lopinavir/ritonavir 3/4 2/5 Lopinavir/ritonavir was re-evaluatedythe NIOSH Hazardous Drug Committee and it was determined that it does not meet the criteria for a hazardous drug and will not be listed on the 2014 haz.ardous drug list.minocycline 2/4 3/5 Minocycline was re-evaluatedythe NIOSH Hazardous Drug Committee and it was detennined that it does not meet the criteria for a haz.ardous drug and will not be listed on the 2014 hazardous drug list. misoprostol 4/4 3/5 Misoprostol will be listed on the 2014 hazardous drug list with specific recommendations about its reproductive risk. It is Pregnancy Category X. nevirapine 3/4 3/3 Nevirapine will be listed on the 2014 hazardous drug list in a non-antineoplastic drug category based on hepatocellular adenonias and carcinomas in laboratory
studies at doses lower than the human dose. omeprazole 2/4 1/5 Omeprazole will not be listed on the 2014 hazardous drug
list as it did not ineet the NIOSH definition of a hazardous drug. Some hyperplasia was observed in laboratory studies at high doses. Following a final review, the expert panel concun•ed with not listing this drug as hazardous. pantoprazole 2/4 0/5 Pantoprazole will not be listed on the 2014 hazardous drug list as it did not meet the NIOSH definition of a hazardous drug. Sonie hyperplasia was observed in laboratory studies at high doses. Following a final review, the expert panel concun•ed with not listing this drug as hazardous. phenytoin 3/4 3/5 Phenytoin will be listed on the 2014 hazardous drug list in a non-antineoplastic drug category and is classified as
IARC 2B with additional recommendations about its re roductive risk. It is Pregnancy Category D. propylthiouracil 2/4 3/5 Propylthiouracil will be listed on the 2014 hazardous drug list in a non-antineoplastic drug category based on IARC Group 2B classification, and with additional recommendations about its reproductive risk. It is Pregnancy Category D.rabeprazole 2/4 1/5 Rabeprazole will not be listed on the 2014 hazardous drug list as it did not meet the NIOSH definition of a hazardous drug. Sonie hyperplasia was observed in laboratory studics at high doses. Pollowing a final review, the experl panel concurred with not listing this drug as hazardous. spironolactone 2/4 3/5 Spironolactone will be listed on the 2014 hazardous drug list in a non-antineoplastic drug category based on a new black box warning for tumorogenicity in laboratory
studies. tapentadol 2/4 1/5 Embryofetal toxicity was observed at doses that produced niaternal toxicity. 7'apentadol will not be listed on the 20141iazardous drug list as it did not meet the NIOSH definition of a hazardous drug. Following a final review, the expert panel concurred with not listing this drug as
hazardous.

tesamorelin 3/4 4/5 Tesaniorelin will not be listed on the 2014 haz,ardous drug list. It is listed as a Pregnancy Category X because there is no beneft to a pregnant woman. The NIOSH Hazardous Drug Coininittee re-evaluated tesamorelin and
determined that it did not meet the criteria for a hazardous drug and would not be listed for 2014. Following a final review, the expert panel concurred with not listing this drug as hazardous. ticagrelor 2/4 1/5 7'icagrelor produced some structural abnonnalities tumors at high doses in laboratory studies. ]t will not be listed on the 2014 hazardous drug list as it did not meet the NIOSH definition of a hazardous drug. Following a final review, the expert panel concurred with not listing this drug as hazardous.tocilizumab 2/4 1/5 Tocilizumab produced abortions and embryofetal death in laboratory studies in monkeys at doses above the human dose. Given the limited possibility for occupational exposures it will not be listed on the 2014 hazardous drug
list as it did not meet the NIOSH definition of a hazardous drug. Following a final review, the expert panel concun•ed with not listing this drug as hazardous. topiramate 4/4 4/5 Topiramate will be listed on the 2014 hazardous drug list with specific recommendations about its reproductive risk. It is Pregnancy Category D. ulipristal 4/4 5/5 Ulipristal will be listed on the 2014 hazardous drug list with specific recommendations about its reproductive risk. It is Pregnancy Category X.

vandetanib NIOSH proposes to include vandetanib on 20141ist based on manufacturer's recommendations for safe handling. It will be listed on the 2014 hazardous drug list as an antineoplastic drug. It is Pregnancy Category D.

vemurafenib 4/4 4/5 Vemurafenib will be listed on the 2014 hazardous drag list as an antineoplastic drug. It is a Pregnancy Category

D.
voriconazole 4/4 4/5 Voriconazole will be listed on the 2014 hazardous drug list with specific recommendations about its reproductive risk. It is Pregnancy Category D.
warfarin 3/4 5/5 VJarfarin will be listed on the 2014 hazardous drug list with specific recommendations about its reproductive risk. It is Pregnancy Category D.Pro osed Deletions

Drusreclassifiedasnot meetincriteria for ahazardous dru tetracycline 1/2 2/2 A$er further review, tetracycline will be removed from the 2014 hazardous drug list. Tetracycline was originally listed as a hazardous drug, because it was part of a combination pharmaceutical that was deemed to meet the NIOSH definition. Tetracycline itself did not meet that definition when reviewed. Following a final review, the expert panel concurred with not listing this drug as
hazardous.