Sarasota Memorial Hospital Hazardous Drug List PHARMACY Handling Categories Category A1 (Low Risk): Primarily oral solids that are not anti-neoplastics. May be tubed and placed in Pyxis • Personal protective equipment not required for dispensing prepackaged intact drug product not requiring manipulation. • Oral solids requiring repackaging: Single pair of chemotherapy gloves. • Oral solids requiring cutting, crushing, or other manipulation will be considered a category B2 (medium risk) hazardous drug, requiring double pair of chemotherapy gloves and chemotherapy gown. Mask required if powder inhalation is a risk. Category A2 (Low-Medium Risk): Primarily anti-neoplastic oral solids - Hand delivered only/Not in Pyxis • Require the same precautions and personal protective equipment as Handling Category A1 above PLUS: • These agents will not be placed in Pyxis and cannot be delivered through the pneumatic tube system and must be hand carried. Category B1 (Medium Risk): Primarily oral liquids, topicals, and injections that are not anti-neoplastics- May be tubed and placed in Pyxis • Personal protective equipment not required for dispensing prepackaged or previously prepared intact product not requiring manipulation. • Drug product requiring repackaging, compounding, or manipulation: Double pair of chemotherapy gloves and chemotherapy gown. Mask required if sterile product or if powder inhalation is a risk. Category B2 (Medium Risk): Antineoplastic oral liquids, topicals, or injections not requiring manipulation and crushed/manipulated HD oral solids. Not tubed/Not in Pyxis • Personal protective equipment not required for dispensing prepackaged or previously prepared intact product not requiring manipulation. • Drug product requiring repackaging, compounding, or manipulation: Double pair of chemotherapy gloves and chemotherapy gown. Mask required if sterile product or if powder inhalation is a risk. Category C (High Risk): Primarily antineoplastic injections. Hand delivered only/Not in Pyxis • Double pair of chemotherapy gloves and chemotherapy gown are required. Outermost gloves must be sterile. • Must be compounded in a ventilated engineering control, utilizing hair/beard cover, mask, and double shoe covers.

NURSING Handling Categories Handling Category A (Low Risk): ): Primarily oral solids • Single pair of chemotherapy gloves required. • Crushed tablets or opened capsules: Treat as Category B. Double pair of chemotherapy gloves and face protection (mask) required to avoid inhalation of powder. Crushing tablets or opening of capsules must be performed in pharmacy. Handling Category B (Medium Risk): Primarily oral liquids, injections, topicals, and crushed or manipulated oral solids • Double pair of chemotherapy gloves required. • Chemotherapy gown recommended if there is a splash potential or risk of spitting or vomiting of the dose after administration. Handling Category C (High Risk): Primarily antineoplastic injections • Double pair of chemotherapy gloves, and chemotherapy gown required (see also Nursing Procedure onc 01).

Definitions (See Exposure Risk Information Section) • IARC: International Agency for Research on Cancer Antineoplastic: Inhibits or prevents the spread of tumors or malignant cells o Group 1: Carcinogenic to humans Black Box warning: The most significant warning for prescription drugs by the FDA when use of a drug has been o Group 2A: Probably carcinogenic to humans associated with serious harm o Group 2B: Possibly carcinogenic to humans Carcinogen: A substance capable of causing cancer in living tissue • NTP: National Toxicology Program classification Carcinoma: Cancer arising in the epithelial tissue of the skin or the lining of the internal organs o NTP** Known to be a human carcinogen Genotoxic: Able to cause damage to the genetic information within a cell o NTP*** Reasonably anticipated to be a human carcinogen Lymphoma: Cancer of the lymph nodes • FDA Pregnancy Categories: FDA drug categorization based on risk of use during pregnancy Malignant: Spread of cancer to nearby tissues and other areas of the body o Category A: Adequate human studies have not shown a risk to the fetus Neoplasm: New abnormal tissue growth, particularly related to cancer o Category B: Animal studies have not shown a risk to the fetus Teratogenic: Use has the potential for causing malformations to an embryo st nd rd o Category C: Animal studies have shown a risk to the fetus, human studies have not Trimesters: 1 : Initial 12 weeks of gestation; 2 : Time from 13 weeks to 27 weeks of gestation; 3 : Time from o Category D: Evidence of risk to the fetus; benefits of medication may outweigh the risks 28 weeks of gestation until delivery o Category X: Evidence of risk to the fetus; risks of medication clearly outweigh benefits Generic Drug Name NIOSH Group Formulation Pharmacy Nursing Exposure Risk Information (Brand Name) Handling Handling NIOSH Supplemental Information Pregnancy Category Category Category Abacavir Non- Malignant tumors observed in male and female mice Oral Solid A1 A C (Ziagen) Antineoplastic and rats; genotoxic in in vivo micronucleus test Acitretin Reproductive Oral Solid A1 A Black Box warning on severe reproductive effects X (Soriatane) Risk Altretamine Antineoplastic Oral Solid A2 A D (Hexalen) Anastrazole Antineoplastic Oral Solid A2 A X (Armidex) Arsenic Trioxide Antineoplastic Injection C C IARC Group 1 carcinogen; NTP** D (Trisenox) Azacitidine Antineoplastic Injection C C IARC Group 2A carcinogen; NTP*** D (Vidaza) Azathioprine Non- Oral Solid A2 A IARC Group 1 carcinogen; NTP* D (Imuran) Antineoplastic Injection C C May cause teratogenicity and/or embryo-fetal lethality Belinostat Antineoplastic Injection C C because it is a genotoxic drug and targets actively D (Beleodaq) dividing cells Bendamustine Antineoplastic Injection C C D (Treanda) Bicalutamide Antineoplastic Oral Solid A2 A X (Casodex) Bleomycin Antineoplastic Injection C C IARC Group 2B D (Blenoxane) Bortezomib Antineoplastic Injection C C D (Velcade) Bosentan Reproductive Oral Solid A1 A Black Box warning on adverse reproductive effects X (Tracleer) Risk Busulfan Antineoplastic Oral Solid A2 A IARC Group 1 carcinogen D (Myleran) Cabazitaxel Antineoplastic Injection C C D (Jevtana) Black Box warning for aplastic anemia; congenital Carbamazepine Non- Oral Solid A1 A malformations in offspring of mothers who took drug; D (Tegretol) Antineoplastic Oral Liquid B1 B rapid transplacental passage Carboplatin Antineoplastic Injection C C D (Paraplatin) Carfilzomib Special warnings on contraception while taking and 2 Antineoplastic Injection C C D (Kyprolis) weeks post-treatment Generic Drug Name NIOSH Group Formulation Pharmacy Nursing Exposure Risk Information (Brand Name) Handling Handling NIOSH Supplemental Information Pregnancy Category Category Category Carmustine Antineoplastic Injection C C IARC Group 2A carcinogen; NTP*** D (BICNU) Chlorambucil Antineoplastic Oral Solid A2 A IARC Group 1 carcinogen; NTP**. D (Leukeran) Chloramphenicol Non- Injection B1 B IARC Group 2A carcinogen; NTP*** D (Chloromycetin) Antineoplastic Cidofovir Non- Injection C C C (Vistide) Antineoplastic Cisplatin Antineoplastic Injection C C IARC Group 2A carcinogen; NTP*** D (Platinol) Cladribine Antineoplastic Injection C C D (Leustatin) Clonazepam Reproductive Increased risk of congenital abnormalities when taken Oral Solid A1 A D (Klonopin) Risk in first trimester Published animal reproduction and development Colchicine Reproductive studies indicate it causes fetal toxicity, teratogenicity, Oral Solid A1 A C (Colcrys) Risk and altered postnatal development at exposures within or above the clinical therapeutic range Cyclophosphamide Oral Solid A2 A Antineoplastic IARC Group 1 carcinogen; NTP** D (Cytoxan) Injection C C Oral Solid A1 A Cyclosporin Ophthalmic Non- B1 B (Neoral, Sandimmune, Drops IARC Group 1 carcinogen; NTP** C Antineoplastic Restasis) Oral Liquid B1 B Injection B2 B Cytarabine (Cytosar-U, Depocyt) Antineoplastic Injection C C D Liposomal Cytarabine (Depocyt) Dacarbazine Antineoplastic Injection C C NTP*** C (DTIC) Dactinomycin (Cosmegen) Antineoplastic Injection C C D

Daunorubicin (Cerubidine, Antineoplastic Injection C C IARC Group 2B, AKA daunomycin D Daumomycin, Daunosome) Generic Drug Name NIOSH Group Formulation Pharmacy Nursing Exposure Risk Information (Brand Name) Handling Handling NIOSH Supplemental Information Pregnancy Category Category Category Decitabine Antineoplastic Injection C C D (Dacogen) Degarelix Antineoplastic Injection C C X (Firmagon) Secondary malignancies observed in patients treated long term with Razoxane (a racemic mixture Dexrazoxane Non- Injection B1 B containing dexrazoxane); genotoxic in vitro and in C (Totect, Zinecard) Antineoplastic vivo; in laboratory studies, testicular atrophy observed at or below the human dose Dinoprostone Reproductive Vaginal Insert B1 B Hazardous only for women in late pregnancy C (Cervidil, Prostin E2) Risk Oral Solid A1 A Black Box warning for teratogenicity; tumors seen in Divalproex Non- Oral Solid / laboratory studies at doses below the maximum D (Depakote) Antineoplastic A1 A Sprinkles recommended human dose Docetaxel Antineoplastic Injection C C D (Taxotere) Doxorubicin (Adriamycin, Doxil, Lipodox) Antineoplastic Injection C C IARC Group 2A carcinogen; NTP*** D Liposomal Doxorubicin (Doxil, Lipodox) Dronedarone Reproductive Oral Solid A1 A Teratogenic in laboratory studies at ½ MRHD X (Multaq) Risk Dutasteride Reproductive Oral Solid A1 A Women warned not to handle X (Avodart) Risk Epirubicin Antineoplastic Injection C C FDA Pregnancy Category D D (Ellence) Eribulin Antineoplastic Injection C C D (Halaven) Black Box warning for malignant neoplasms; increased Estradiol Oral Solid A1 A risk of endometrial cancer, breast cancer, and ovarian (Alora, Climara, Non- Topical B1 B cancer; in laboratory studies, increased frequency of X Delestogen, Estrace, Antineoplastic Vaginal Insert B1 B carcinomas of the breast, uterus, cervix, vagina, testis, Estraderm, Vagifem) Injection B1 B and liver; present in breast milk

Estramustine Antineoplastic Oral Solid A2 A X (Emyct)

Estrogens-Conjugated Non- Oral Solid A1 A Black Box warning for endometrial cancer and X (Premarin) Antineoplastic Topical B1 B cardiovascular risks; long-term use in women Generic Drug Name NIOSH Group Formulation Pharmacy Nursing Exposure Risk Information (Brand Name) Handling Handling NIOSH Supplemental Information Pregnancy Category Category Category increases the frequency of several cancers; NTP** Injection B1 B

Estrogens- Conjugated Estrogens: Black Box warning for Conjugated/Medroxy Non- endometrial cancer and cardiovascular risks; long-term progesterone Antineoplastic Oral Solid A1 A use in women increases the frequency of several X (Prempro) cancers; NTP** Medroxyprogesterone: IARC Group 2B Estrogens-Esterified Non- Black Box warning for endometrial cancer and (Estratab, Estratest, Oral Solid A1 A X Antineoplastic cardiovascular risks; NTP** Menest) Estropipate Non- Oral Solid A1 A Black Box warning for endometrial carcinoma in post- X (Ogen) Antineoplastic Topical B1 B menopausal women and use during pregnancy Etoposide Oral Solid A2 A Antineoplastic IARC Group 1 carcinogen D (Vepesid) Injection C C Exemestane Antineoplastic Oral Solid A2 A X (Aromasin) Women should not handle crushed or broken Finasteride Reproductive finasteride tablets when they are pregnant or may Oral Solid A1 A X (Proscar) Risk potentially be pregnant, due to potential risk to a male fetus Floxuridine Antineoplastic Injection C C D (FUDR) Oral Solid A1 A Case reports describe congenital anomalies in infants Fluconazole Reproductive exposed in utero to maternal fluconazole (400–800 Oral Liquid B1 B C (Diflucan) Risk mg/day) during most or all of the first trimester, Injection B1 B similar to those seen in animal studies Fludarabine Antineoplastic Injection C C D (Fludara) Fluorouracil Topical B2 B Antineoplastic D (5-FU, Efudex) Injection C C Fosphenytoin Non- Injection B1 B Metabolized to phenytoin: IARC Group 2B; NTP*** D (Cerebyx) Antineoplastic Fulvestrant Antineoplastic Injection C C D (Faslodex) Ganciclovir Non- Oral Solid A2 A C (Cytovene) Antineoplastic Injection C C Gemcitabine Antineoplastic Injection C C C (Gemzar) Generic Drug Name NIOSH Group Formulation Pharmacy Nursing Exposure Risk Information (Brand Name) Handling Handling NIOSH Supplemental Information Pregnancy Category Category Category Hydroxyurea Antineoplastic Oral Solid A2 A Special warning on handling bottles and capsules D (Hydrea) Hydroxyprogesterone Non- Injection B1 B B (Hydrea) Antineoplastic Idarubicin Antineoplastic Injection C C D (Idamycin) Ifosfamide Antineoplastic Injection C C D (Ifex) Imatinib Antineoplastic Oral Solid A2 A D (Gleevac) Irinotecan Antineoplastic Injection C C D (Captosar) Ixabepilone Antineoplastic Injection C C D (Ixempra) Teratogenic in laboratory studies at 1/10 the human Leflunomide Non- dose; marked postnatal survival at 1/100 the human Oral Solid A1 A X (Arava) Antineoplastic dose; severe liver injury reported; carcinogenicity observed at doses below the human dose Letrozole Antineoplastic Oral Solid A2 A X (Femara) Levonorgestrel Non- Oral Solid A1 A X (Plan B) Antineoplastic Lomustine Antineoplastic Oral Solid A2 A IARC Group 2A carcinogen; NTP*** D (CeeNU) Mechlorethamine Antineoplastic Injection C C NTP*** D (Mustargen) Medroxyprogesterone Non- Oral Solid A1 A IARC Group 2B X (Provera) Antineoplastic Injection B1 B Breast feeding should be discontinued if megestrol is Megestrol Oral Solid A2 A Antineoplastic required; women at risk of pregnancy should avoid X (Megace) Oral Liquid B2 B exposure Melphalan Oral Solid A2 A Antineoplastic IARC Group 1 carcinogen; NTP** D (Alkeran) Injection C C Mercaptopurine Antineoplastic Oral Solid A2 A FDA Pregnancy Category D D (Purinethol) Methimazole Non- Oral Solid A1 A Appears in human breast milk D (Tapazole) Antineoplastic Oral Solid A2 A Methotrexate Antineoplastic X Injection C C Generic Drug Name NIOSH Group Formulation Pharmacy Nursing Exposure Risk Information (Brand Name) Handling Handling NIOSH Supplemental Information Pregnancy Category Category Category Methylergonovine Reproductive Oral Solid A1 A Use is contraindicated during pregnancy because of its C (Methergine) Risk Injection B1 B ability to induce uterine contractions Misoprostol Reproductive Oral Solid A1 A X (Cytotec) Risk Mitomycin Antineoplastic Injection C C IARC Group 2B D (Mutamycin) Mitotane Antineoplastic Oral Solid A2 A D (Lysodren) Mitoxantrone Antineoplastic Injection C C IARC Group 2B D (Novantrone) Black Box warning for first trimester pregnancy loss Mycophenolic Acid Non- and increased risk of congenital malformations; Black Oral Solid A1 A D (Myfortic) Antineoplastic Box warning for lymphomas and other malignancies; genotoxic in vitro and in vivo. Black Box warning for embryo fetal toxicity, Oral Solid A1 A malignancies, and serious infections; increased risk of first-trimester pregnancy loss and increased risk of congenital malformations; Special warning: Tablets should not be crushed and Mycophenolate Mofetil Non- Oral Liquid B1 B capsules should not be opened or crushed. Avoid D (Cellcept) Antineoplastic inhalation or direct contact with skin or mucous membranes of the powder contained in capsules and oral suspension (before or after constitution). If such Injection B2 B contact occurs, wash thoroughly with soap and water; rinse eyes with plain water. Oral Solid A1 A In laboratory studies, hepatocellular adenomas and Nevirapine Non- carcinomas were seen at doses lower than human B (Viramune) Antineoplastic Oral Liquid B1 B dose Oxaliplatin Antineoplastic Injection C C D (Eloxatin) Oxcarbazepine Non- Oral Solid A1 A Tumors observed in laboratory studies at 1/10 the C (Trileptal) Antineoplastic Oral Liquid B1 B maximum recommended human dose Oxytocin Reproductive Injection B1 B Hazardous only for women in third trimester C (Pitocin) Risk Paclitaxel (Taxol) Antineoplastic Injection C C D Paclitaxel Albumin (Abraxane) Paliperidone Non- Oral Solid A1 A Metabolite of risperidone; excreted in human breast C Generic Drug Name NIOSH Group Formulation Pharmacy Nursing Exposure Risk Information (Brand Name) Handling Handling NIOSH Supplemental Information Pregnancy Category Category Category (Invega) Antineoplastic Injection B1 B milk Pamidronate Reproductive Embryo-fetal toxicities at doses below the Injection B1 B D (Aredia) Risk recommended human dose Increased risk of congenital abnormalities when taken Paroxetine Reproductive Oral Solid A1 A in first trimester; complications in pregnancy when D (Paxil) Risk taken in third trimester Pemetrexed Antineoplastic Injection C C D (Alimta) Pentostatin Antineoplastic Injection C C D (Nipent) Pertuzumab Black Box warning on embryo-fetal death and birth Antineoplastic Injection C C D (Perjeta) defects Phenoxybenzamine Non- Oral Solid A1 A IARC Group 2B C (Dibenzyline) Antineoplastic Oral Solid A1 A Phenytoin Non- Oral Liquid B1 B IARC Group 2B; NTP*** D (Dilantin) Antineoplastic Injection B1 B Procarbazine Antineoplastic Oral Solid A2 A IARC Group 2A carcinogen; NTP*** D (Matulane) Oral Solid A1 A Progesterone Non- Topical B1 B IARC Group 2B; NTP*** NA (Crinone, Prometrium) Antineoplastic Injection B1 B Propylthiouracil Non- Oral Solid A1 A IARC Group 2B; NTP*** D (PTU) Antineoplastic Rasagiline Non- Oral Solid A1 A C (Azilect) Antineoplastic Teratogenic and embryotoxic effects in several Ribavirin Reproductive laboratory studies; contraindicated in women who are Oral Solid A1 A X (Rebetrol, Virazole) Risk pregnant and in the male partners of women who are pregnant Oral Solid A1 A Risperidone Non- Evidence of tumors at low doses in laboratory studies; Oral Liquid B1 B C (Risperdal) Antineoplastic may be prolactin-mediated Injection B1 B Sirolimus AKA rapamycin; increased risk of lymphomas and (Rapamune) Non- Oral Solid A1 A other malignancies; embryotoxic and fetotoxic at 1/5 C Antineoplastic the human dose

Spironolactone Non- Oral Solid A1 A Black Box warning for tumorogenicity seen in C Generic Drug Name NIOSH Group Formulation Pharmacy Nursing Exposure Risk Information (Brand Name) Handling Handling NIOSH Supplemental Information Pregnancy Category Category Category (Aldactone) Antineoplastic laboratory studies Oral Liquid B1 B

Oral Solid A1 A Increased risk of lymphomas and other malignancies; Tacrolimus Non- Topical B1 B reproductive effects seen in laboratory studies below C (Prograf, Protoptic) Antineoplastic Injection B2 B the MRHD; excreted in breast milk Tamoxifen Antineoplastic Oral Solid A2 A IARC Group 1 carcinogen; NTP** D (Nolvadex) Black Box warning for potential risk to fetus and Televancin Reproductive adverse reproductive outcomes; reduced fetal weights Injection B1 B C (Vibativ) Risk and increased rates of digit and limb malformations in three species at clinical doses

Temazepam Reproductive Increased risk of congenital malformations associated Oral Solid A1 A X (Restoril) Risk with treatment during the first trimester of pregnancy Temozolomide Antineoplastic Oral Solid A2 A D (Temodar) Temsirolimus Antineoplastic Injection C C D (Torisel) Testosterone Topical B1 B (Androderm, Reproductive Children should avoid contact with unwashed or X Denatestryl, Depo- Risk Injection B1 B unclothed application sites on skin Testost, Testoderm) Thioguanine Antineoplastic Oral Solid A2 A D (Thioguanine)

Topiramate Reproductive Oral Solid A1 A D (Topamax) Risk

Topotecan Antineoplastic Injection C C D (Hycamtin) Tretinoin Reproductive Black Box warning for severe birth defects; Special FDA Oral Solid A1 A X (Retin-A, Vesanoid) Risk distribution system Oral Solid A1 A Valganciclovir Non- C (Valcyte) Antineoplastic Oral Liquid B1 B

Oral Solid A1 A Black Box warning for teratogenicity; Congenital Valproic Acid Reproductive Oral Liquid B1 B malformations, including neural tube defects; D (Depakene) Risk Injection B1 B teratogenic in multiple species Vinblastine Antineoplastic Injection C C D (Velban) Generic Drug Name NIOSH Group Formulation Pharmacy Nursing Exposure Risk Information (Brand Name) Handling Handling NIOSH Supplemental Information Pregnancy Category Category Category Vincristine Antineoplastic Injection C C D (Oncovin)

Vinorelbine Antineoplastic Injection C C D (Navelbine)

Voriconazole Reproductive Oral Solid A1 A D (Vfend) Risk Injection B1 B Warfarin Reproductive Oral Solid A1 A D (Coumadin) Risk Zidovudine Oral Liquid B1 B (Retrovir) Non- IARC Group 2B C Antineoplastic Injection B1 B

Developmental toxicity, including possible teratogenic Oral Solid A1 A effects at doses similar to human therapeutic doses; Ziprasidone Reproductive animal studies show an increase in the number of C (Geodon) Risk Injection B1 B stillbirths and a decrease in postnatal survival at less than the maximum recommended human dose Zoledronic Acid Reproductive Number of stillbirths increased and survival of Injection B1 B D (Reclast, Zometa) Risk neonates decreased in laboratory studies at low doses Zonisamide Reproductive Oral Solid A1 A Teratogenic in multiple miscellaneous animal species D (Zonegran) Risk