bortezomib
Print| Trade Name(s): Velcade; Bortezomib | |
| Group 1: Antineoplastic Hazardous | AHFS Class: Antineoplastic Agents |
| Formweb: bortezomib | |
| Info Links: Chemotherapy Extravasation Policy | |
| Activity | Glove | Gown | Eye | Mask (N95/PAPR) | CSTD |
| Administration |  |  |
If splashing possible |
If inhalation possible |  |
| Waste/Disposal of drug | | |  If splashing possible |
Nursing Antineoplastic Drugs PPE and Work Practices (Link to a file uploaded to Rhazdrugs or to a file on your intranet, or a shared drive.)
Handling of bodily fluids and/or contaminated materials
| Drug Form | Glove | Gown | Eye | Mask (N95/PAPR) | Shoe |
| All forms | | | If splashing possible |
- Symptoms are; tenderness, warmth, or redness along the vein or at the injection site.
- A variation to this is a hypersensitivity "flare reaction" at the injection site.
- Symptoms of this reaction are redness and itching at the injection site.
Local skin irritation was reported in 5% of patients, but extravasation of bortezomib was not associated with tissue damage. If signs or symptoms of extravasation occur the injection or infusion should be terminated immediately and initiate appropriate management measures in accordance with institutional policies
| Vesicant or Irritant | Apply Heat or Cold | Additional treatment/antidote |
| Irritant | Cold - 15 to 20 minutes at a time for at least four times per day for 24 hours | Initiate substance-specific measures per physician orders. |
References: DailyMed, Hemonc.org, Chemocare
| Hazardous Drug Waste EPA Regulated & Chemo/HAZ-MEDs | Trace Chemo | Regulated Medical Waste & Sharps | Outer Packaging | Controlled Substances | EXP Returns for Credit |
 |  |  |  |  | Expired Return Bins |
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| controlled substances | full/unopened returnable containers |
EPA Regulated Drugs
Non-EPA Regulated
| TRACE Chemo waste: gowns, mats, etc. with NO VISIBLE CONTAMINATION plus EMPTY vials, EMPTY syringes, etc. Exception: EMPTY packaging for arsenic trioxide must be disposed in the BLACK container If visible contamination OR visible drug, dispose in the BLACK container. | Infectious Waste
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Pour/Discard drug into controlled substance waste container and discard empty packaging in trash or RED container (if sharp) |
See "Guidelines for Discarding Medications" |
*Empty packaging that has had physical contact with hazardous drug (NO OUTER PACKAGING)
| 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 |  |
| Glove | Gown | Eye | Mask | Shoe | Head Cover | Hood/Cabinet | CSTD | Notes/Instructions |
(outer layer should be sterile) |
(outer layer should be chemo rated) |
|  |  |
| | Any secondary layers of PPE should be removed/discarded prior to exiting the C-PEC |
| 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 | |
Group 1 NIOSH - Full USP <800> precautions required - No Assessment of Risk allowed.
| Dosage Form | Risk of Exposure | Packaging | Pharmacy Manipulation | Nurse Manipulation |
| Injectable | May occur when compounding and administration | Not eligible for AoR | Not eligible for AoR |
| |  | | |  | | |
| 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
Bortezomib is a reversible inhibitor of the chymotrypsin-like activity of the 26S proteasome in mammalian cells. The 26S proteasome is a large protein complex that degrades ubiquitinated proteins. The active site of the proteasome has chymotrypsin-like, trypsin-like, and postglutamyl peptide hydrolysis activity. The 26S proteasome degrades various proteins critical to cancer cell survival, such as cyclins, tumor suppressors, BCL-2, and cyclin-dependent kinase inhibitors. Inhibition of these degradations sensitizes cells to apoptosis. Bortezomib is a potent inhibitor of 26S proteasome, which sensitizes activity in dividing multiple myeloma and leukemic cells, thus inducing apoptosis. In addition, bortezomib appears to increase the sensitivity of cancer cells to traditional anticancer agents (e.g., gemcitabine, cisplatin, paclitaxel, irinotecan, and radiation).
Reference: Drug Bank
- Harmful if swallowed.
Reference: SDS Cayman Chemical
