abiraterone
Print| Trade Name(s): Zytiga | |
| Group 1: Antineoplastic Hazardous | AHFS Class: Antineoplastic Agents |
| Formweb: abiraterone | |
| Info Links: Chemotherapy Extravasation Policy | |
Administration:
Oral solid (with pediatric)
| Activity | Glove | Gown | Eye | Mask (N95/PAPR) | Equipment |
| Administration |  |  If powder is present from non-intact tablet or capsule | |||
| Manipulation of oral solid (pediatrics only) |  |  |  | |  utilize crusher w/pouch to contain particles |
| Waste/Disposal of drug | | | If powder generated |
Patient Care Activities:
AN- PPE During Handling of Bodily Fluids, contaminated materials (LH)
Handling of bodily fluids and/or contaminated materials
| Drug Form | Glove | Gown | Eye | Mask (N95/PAPR) | Shoe |
| All forms | | |  If splashing possible |
Disposal:
Antineoplastic Agents (LH)
Receiving and Storage:
AN-Receiving & Storage (LH)
| Form | Receipt Packaging | Environment | Glove | Storage |
| Intact tablet/capsule from UD package | Separate totes, plastic wrap | Neutral/normal or negative pressure room, not in sterile compounding area | | Final dosage forms of AN may be stored with normal inventory. Refrigerated AN must be stored in dedicated fridge in negative pressure area with minimum 12 ACPH. |
| Non-intact, repackaged tablet or capsule | N/A | N/A | | Segregated area, negative pressure room, externally ventilated, minimum 12 ACH; refrigerated AN must be stored in dedicated fridge in negative pressure area with minimum 12 ACPH. |
| Oral liquid drug or feeding tube | Separate totes, plastic wrap | Neutral/normal or negative pressure room, not in sterile compounding area | | Final dosage forms of AN may be stored with normal inventory. Refrigerated AN must be stored in dedicated fridge in negative pressure area with minimum 12 ACPH. |
| Powder for oral liquid | Separate totes, plastic wrap | Neutral/normal or negative pressure room, not in sterile compounding area | | Segregated area, negative pressure room, externally ventilated, minimum 12 ACH; refrigerated AN must be stored in dedicated fridge in negative pressure area with minimum 12 ACPH. |
| Topical drug | Separate totes, plastic wrap | Neutral/normal or negative pressure room, not in sterile compounding area | | Final dosage forms of AN may be stored with normal inventory. Refrigerated AN must be stored in dedicated fridge in negative pressure area with minimum 12 ACPH. |
| Powder, solution for inhalation | Separate totes, plastic wrap | Neutral/normal or negative pressure room, not in sterile compounding area | | Final dosage forms of AN may be stored with normal inventory. Refrigerated AN must be stored in dedicated fridge in negative pressure area with minimum 12 ACPH. |
| Vial; ampule; pre-filled syringe | Separate totes, plastic wrap | Neutral/normal or negative pressure room, not in sterile compounding area | | Final dosage forms may be stored with normal inventory. AN requiring manipulation must be segregated area, negative pressure room, externally ventilated, minimum 12 ACPH; refrigerated AN must be stored in dedicated fridge in negative pressure area with minimum 12 ACPH. |
| Intravenous solution | Separate totes, plastic wrap | Neutral/normal or negative pressure room, not in sterile compounding area | | Final dosage forms may be stored with normal inventory. AN requiring manipulation must be segregated area, negative pressure room, externally ventilated, minimum 12 ACPH; refrigerated AN must be stored in dedicated fridge in negative pressure area with minimum 12 ACPH. |
| Irrigation solution | Separate totes, plastic wrap | Neutral/normal or negative pressure room, not in sterile compounding area | | Final dosage forms may be stored with normal inventory. AN requiring manipulation must be segregated area, negative pressure room, externally ventilated, minimum 12 ACPH; refrigerated AN must be stored in dedicated fridge in negative pressure area with minimum 12 ACPH. |
Spill Containment | Notes/Instructions | PPE Required |
 | Wear N95 or PAPR mask if you see powders present | |
Preparation:
Orals AN (LH)
| Glove | Gown | Eye | Mask (N95/PAPR) | Shoe |
| |
If not in controlled environment |
If not in controlled environment |  |
*Drug may not be placed in automated repackaging or counting device.
Transport:
Transport of AN
| Form | Prep Instructions | Pneumatic Tube |
| Intact tablet/capsule from UD package | Sealed plastic bag, single pair of gloves, cautionary labeling |  |
| Non-intact, repackaged tablet or capsule | Sealed plastic bag, single pair of gloves, cautionary labeling | |
| Oral liquid drug or feeding tube | Sealed plastic bag, single pair of gloves, cautionary labeling | |
| Topical drug | Sealed plastic bag, single pair of gloves, cautionary labeling |  |
| Powder, solution for inhalation | Sealed plastic bag, single pair of gloves, cautionary labeling | |
| Vial; ampule; pre-filled syringe | Sealed plastic bag, single pair of gloves, cautionary labeling | |
| Intravenous solution | Sealed plastic bag, single pair of gloves, cautionary labeling | |
| Irrigation solution | Sealed plastic bag, single pair of gloves, cautionary labeling | |
PPE:
PPE Guidelines
| | | | |  |  |  |
| Chemotherapy rated/tested (tested to ASTM D6978-05 (2013), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs) | Disposable
| Should be worn in situations where eye, mouth, or nasal splashing is possible (i.e., during a bladder instillation of a hazardous drug) | Goggles protect the eyes, but not the face, against spraying. | Certified N95 | Powered air purifying respirator | required for compounding sterile and nonsterile hazardous drugs | required for compounding sterile and nonsterile hazardous drugs |
| Powder-free | Shown to resist permeation by hazardous drugs
| N95 offers no protection against gases and vapors. | For events such as large spills when an IV bag breaks or a line disconnects and leaks, or where there is known or suspected airborne exposure to vapors or gases | Double booties required for HD preparation areas, top layer is doffed before exiting the HD buffer room. | |||
| Inspect for visible defects | Must close in the back (no open front) | Surgical masks do NOT provide respiratory protection from drug exposure | Hazardous drugs with potential to vaporize at room temperature: • Carmustine • Cisplatin •Cyclophosphamide • Etoposide • 5-Fluorouracil • lfosfamide • Thiotepa | ||||
| Double gloving is recommended for all activities involving hazardous drugs except for handling intact, unit-dose oral agents, when one pair of chemotherapy-tested gloves is acceptable | Long sleeves with closed cuffs that are elastic or knit | ||||||
| When wearing double gloves, tuck the cuff of the inner glove under the gown sleeve and the cuff of the outer glove over the gown sleeve. | No seams or closures that could allow hazardous drugs to pass through | ||||||
| During medication manipulation/compounding the outer layer should be sterile | In preparation areas gowns should be changed every 2-3 hours or immediately after a spill or splash | ||||||
Change gloves every 30 minutes unless permeation testing has noted shorter time limits
| Gowns worn in hazardous drug handling areas must NOT be worn to other areas |
Sequence for Donning & Doffing PPE
References: Oncology Nursing Society, NIOSH
Mechanism of Action:
Abiraterone is an orally active inhibitor of the steroidal enzyme CYP17A1 (17 alpha-hydroxylase/C17,20 lyase). It inhibits CYP17A1 in a selective and irreversible manner via covalent binding mechanism. CYP17A1 is an enzyme that catalyzes the biosynthesis of androgen and is highly expressed in testicular, adrenal, and prostatic tumor tissue. More specifically, abiraterone inhibits the conversion of 17-hydroxyprognenolone to dehydroepiandrosterone (DHEA) by the enzyme CYP17A1 to decrease serum levels of testosterone and other androgens.
Reference: Drug Bank
Exposure Risk:
- Suspected of damaging fertility or the unborn child
- May cause damage to organs through prolonged or repeated exposure
Reference: SDS - Cayman Chemical
Safety Data Sheet(s):
Supplemental Information:
NIOSH 2016: "Women who are pregnant or may be pregnant should not handle without protection (e.g., gloves)"
NIOSH 2020: "Only met the NIOSH criteria as a developmental and/or reproductive hazard; Women who are pregnant or women who may be pregnant should not handle without protection (e.g., gloves)"
Approved on November 22, 2024
