bendamustine

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Trade Name(s): Belrapzo; Bendamustine Hydrochloride; Bendeka; Treanda; Vivimusta
Group 1: Antineoplastic Hazardous AHFS Class: Antineoplastic Agents
Formweb: bendamustine
Info Links: Chemotherapy Extravasation Policy
Injectable = vial, syringe, IV solution, irrig solution, non-ampule, AN (LH)
ActivityGloveGownEyeMask (N95/PAPR)CSTD
AdministrationGloves DoubleGown

Goggles

If splashing

possible

Mask

If inhalation

possible

Closed System Transfer
Waste/Disposal of drugGloves DoubleGownGoggles
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.)

AN- PPE During Handling of Bodily Fluids, contaminated materials (LH)

Handling of bodily fluids and/or contaminated materials

Drug FormGloveGownEyeMask (N95/PAPR)Shoe
All formsGloves DoubleGownGoggles
If splashing
possible


Extravasation:

Irritant (usually):

  • 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.

Vesicant (rare):

  • The reaction to vesicants initially looks like an irritation but may worsen, depending on the amount of vesicant that has leaked under the skin.
  • Vesicants can cause redness and blistering. Larger amounts of vesicant leakage from the chemotherapy injection can lead to severe skin damage in a matter of days.
  • Symptoms from leakage of vesicants may be delayed for up to 6-12 hours after chemotherapy injection.
  • Complaints of itching are common in the absence of pain.
  • Severity of the injection site reaction depends on the vesicant potential of the drug, the amount and concentration of the drug exposure, and the immediate measures taken once the extravasation occurs.

Bendamustine hydrochloride extravasations have been reported in post-marketing resulting in hospitalizations from erythema, marked swelling, and pain. Assure good venous access prior to starting drug infusion and monitor the intravenous infusion site for redness, swelling, pain, infection, and necrosis during and after administration.

Vesicant or IrritantApply Heat or ColdAdditional treatment/antidote
Irritant (usually)
Vesicant (rare)
Cold - for 6 to 12 hoursInitiate substance-specific measures per physician orders.

References: DailyMedHemonc.org, Chemocare


Injectable (AN), or any bulk powder of any group (LH)
GloveGownEyeMaskShoeHead CoverHood/CabinetCSTDNotes/Instructions
Gloves Double
(outer layer should be sterile)

GownGown

(outer layer should be chemo rated)


Mask Surgical


Shoe Covers DoubleHair CoverHair Cover

Biohazard Hood

Closed System TransferAny secondary layers of PPE should be removed/discarded prior to exiting the C-PEC

Pharmacy Antineoplastic Drugs PPE and Work Practices

Transport of AN
FormPrep Instructions

Pneumatic

Tube

Intact tablet/capsule from UD packageSealed plastic bag, single pair of gloves, cautionary labelingDo Not Tube
Non-intact, repackaged tablet or capsuleSealed plastic bag, single pair of gloves, cautionary labeling
Do Not Tube
Oral liquid drug or feeding tubeSealed plastic bag, single pair of gloves, cautionary labeling
Do Not Tube
Topical drugSealed plastic bag, single pair of gloves, cautionary labeling
Tube Ok
Powder, solution for inhalationSealed plastic bag, single pair of gloves, cautionary labeling
Do Not Tube
Vial; ampule; pre-filled syringeSealed plastic bag, single pair of gloves, cautionary labeling
Do Not Tube
Intravenous solutionSealed plastic bag, single pair of gloves, cautionary labeling
Do Not Tube
Irrigation solutionSealed plastic bag, single pair of gloves, cautionary labeling
Do Not Tube

Pharmacy Antineoplastic Drugs PPE and Work Practices

Assessment of Risk:

Group 1 NIOSH - Full USP <800> precautions required - No Assessment of Risk allowed.

Dosage FormRisk of ExposurePackagingPharmacy ManipulationNurse Manipulation
InjectableMay occur when compounding
and administration
Not eligible for AoRNot eligible for AoRNot eligible for AoR


PPE Guidelines
Gloves DoubleGownFace ShieldGoggles
MaskPap Respirator
Hair CoverShoe Covers Double
Chemotherapy rated/tested
(tested to ASTM D6978-05 (2013), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs)
Disposable
  • must not be reused
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 N95Powered air purifying respiratorrequired for compounding sterile and nonsterile hazardous drugsrequired for compounding sterile and nonsterile hazardous drugs
Powder-freeShown to resist permeation by hazardous drugs
  • material: polyethylene-coated polypropylene or other laminate materials
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 gasesDouble booties required for HD preparation areas, top layer is doffed before exiting the HD buffer room.
Inspect for visible defectsMust close in the back
(no open front)
Surgical masks do NOT provide respiratory protection from drug exposureHazardous 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 acceptableLong 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 sterileIn 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
  • change gloves immediately if damaged or contaminated
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:

Bendamustine is a bifunctional mechlorethamine derivative capable of forming electrophilic alkyl groups that covalently bond to other molecules. Through this function as an alkylating agent, bendamustine causes intra- and inter-strand crosslinks between DNA bases resulting in cell death. It is active against both active and quiescent cells, although the exact mechanism of action is unknown.

Reference: Drug Bank

Exposure Risk:

  • Toxic if swallowed. 
  • Suspected of causing cancer. 
  • May damage fertility or the unborn child.

Reference: SDS - Cayman Chemical

Supplemental Information:

NIOSH 2020: Cytotoxic; Developmental toxicity

Approved on November 22, 2024