fulvestrant

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Trade Name(s): Faslodex
Group 1: Antineoplastic Hazardous AHFS Class: Antineoplastic Agents
Formweb: fulvestrant
Info Links: Chemotherapy Extravasation Policy
Administration:
Injectable (IV/IM/SQ)
HandlingGloves
(ASTM D6978)
Gown
(Fluid resistant, ASTM rated)
Eye/Face
Protection
MaskShoe
Covers
CSTDNotes/Instructions
Preparation at Bedside (Contact pharmacy)Gloves DoubleGownGoggles
for splash concerns
Place and prepare on a disposable chemo prep pad.
AdministrationGloves Double
GownGogglesClosed System Transfer
Deactivating, decontaminating,
cleaning, and disinfecting
Gloves DoubleWipe
Deactivate, decontaminate, clean, and disinfect area and equipment after use and between HazDs by wiping twice with Peridox® RTU and allow a 3-minute dwell time after the second wipe. Follow wiping with 70% Isopropyl Alcohol


Handling Spills 
Gloves DoubleGownGogglesMaskShoe CoversSpill KitFollow instructions on spill-kit package
PPE Disposal
Yellow Bin 
Drug DisposalReference EPIC for Regulated/RCRA waste code for Ochsner Health Medication/Waste Handling Guide for disposal of HazDs.

Ochsner HD Handling PPE Guide

Patient Care Activities:
Handling Patient Bodily Fluids (OH)
HandlingGloves
(ASTM D6978)
Gown
(Fluid resistant, ASTM rated)
Eye/Face
Protection
Shoe
Covers
MaskNotes/Instructions
Patient Care Activities -
Urine, feces, sweat, or vomit
Gloves DoubleGownGoggles
for concerns
of splash
Shoe Covers
for concerns
of splash

Ochsner HD Handling PPE Guide

Hazardous Waste Guide (OH)

Reference EPIC for Regulated/RCRA waste code or Ochsner Health Medication Waste Guide.

Medication regulated by RCRA will be identified with a waste disposal code on the MAR or EHR. Waste codes include BKC, PBKC, SP, SPC, SPO, SPLP, CHEMO, DEA

CodeNotes/InstructionsContainer
BKCNurse shall dispose in appropriately labeled BLACK BKC containerBlack Bin
CHEMO

Nurse/pharmacy shall place chemo waste in either a YELLOW trace chemo container or a BLACK “Bulk” chemo waste container.
  • BLACK container labeled for BULK CHEMO waste shall be utilized for chemotherapy waste with residual of 3% or more drug remaining. All chemotherapy is considered regulated/RCRA by EPA/RCRA and USP 800 regulations. Waste vendor picks up.
  • Yellow “Trace” Chemo containers are ordered through Lawson and picked up by the vendor or the department with responsibility for biohazard waste in each facility (along with regulated medical waste, red sharps, and non-regulated Rx waste). Containers shall be used for “empty” chemotherapy vials, IV bags, syringes, along with any material used during the preparation, administration and handling of the chemotherapy, including all personal protective equipment (PPE).

Black Bin

Yellow Bin
DEAControlled substance medication waste shall be placed in "Cactus" system, or in "RxDestroyer" system.Cactus Sink Stericycle
PBKCNurse shall place package/wrapper of medication in a zipper sealed bag, then dispose in appropriately labeled BLACK PBKC container in facilities where PBKC container is available. Until available, nurse shall send bag back to the pharmacy for disposal. 
  • *Off site clinics do not return pharmaceutical waste to pharmacy
  • Arsenic Trioxide (Trisenox) vials, IV bags, tubing, syringes and other materials used in preparation and administration shall be disposed of a segregated "PBKC" listed waste in 8-gallon black waste containers and labels provided by hazardous waste vendor. **Under NO circumstances can arsenic trioxide be combined with other hazardous waste**
Examples of P-listed waste: Coumadin, Warfarin, Nicotine patches and their packaging

Black Bin
SPNurse shall place the aerosol/inhaler in a zipper sealed bag and send to pharmacy for disposal in appropriately labeled BLACK container.
  • Off site clinics to not return pharmaceutical waste to pharmacy
PHARMACY
SPCNurse shall place corrosive in zipper sealed bag and send to pharmacy for disposal in appropriately labeled BLACK SPC container.
  • *Off-site locations do not return pharmaceutical waste to pharmacy
PHARMACY
SPONurse shall place oxidizer in a zipper sealed bag and send to pharmacy for disposal in appropriately labeled BLACK SPO container.
  • *Off-site locations do not return pharmaceutical waste to pharmacy.
PHARMACY
SPLPNurse shall place SPLP waste in a zipper sealed bag and send to pharmacy for disposal in appropriately labeled BLACK SPLP container.
  • *Off-site locations do not return pharmaceutical waste to pharmacy.
PHARMACY
No waste code
(ON site)
Shall be disposed of in a BLUE pharmaceutical waste container, with the exception of off-site provider-based clinics and freestanding emergency departments which shall use only black pharmaceutical waste containers.
Facility based (on-site) clinics may use containers in the same manner as inpatient. 
Blue Bin
No waste code
(OFF-site)
OFF-site provider-based clinics and freestanding emergency departments which shall use only black pharmaceutical waste containers.Black Bin
Disposal DeterminationNotes/InstructionsContainer
Non-chemo medication packages
containing less than 3% of the pharmaceutical
Shall be considered “empty” and shall be disposed of in regular trash containers or BLUE non-regulated Rx waste containers. Trash Can

Blue Bin
Medications and/or medication
containers (vials, ampoules, cups, IV bags) with 3% or more than 3% medication remaining
Shall be disposed of in pharmaceutical waste containers indicated by the EPIC system, or in Pyxis and shall appear on the medication labels printed by pharmacy. Drug Specific
Empty sharpsShall be disposed of in RED sharps containers.Red Bin
Sharps with medicationShall be disposed of in a BLACK 2-gallon sharps containerBlack Bin
Free flowing liquids or pharmaceutical packages with the potential to leakShall be placed in a zipper sealed bag prior to disposal in designated pharmaceutical waste containerDrug
Specific

Regulated/RCRA Pharmaceutical Waste Disposal

Ochsner Health Medication/Waste Handling Guide


Receiving and Storage:
Group 1 (OH)
HandlingGloves
(ASTM D6978)
Gown
(Fluid resistant, ASTM rated)
Shoe Covers
(white polyethylene)
Mask
(N95)
Eye/FaceNotes/Instructions
ReceivingGloves Doubleunpack using same procedures as non-HazDs
Storage
Shall be stored in a resealable clear plastic bag or bin with yellow (chemotherapy, cytotoxic) hazardous drug labeling or sticker

Drugs requiring manipulation other than counting or repackaging of the final dosage form and any Active Pharmaceutical Ingredients (API) shall be stored:
  • Separately from any HazDs
  • In an externally vented, negative pressure room with at least 12 air changes per hour (ACPH).
  • Drugs that require refrigeration shall be stored:
  • Separately from non-HazDs
  • In a dedicated refrigerator
  • In an externally vented, negative pressure room with at least 12 air changes per hour (ACPH).
  • Drugs received in the manufacturer's final dosage form or in a form that requires only counting or repackaging may be stored:
  • Preferably in a negative pressure room
  • Preferable separate from non-HazDs
OHS.PHARM.SOP.055 - Storage
Storage waiting for patient pickup
*Retail/Specialty Only
Drugs shall be stored in a resealable clear plastic bag with yellow (chemotherapy, cytotoxic) HazD labeling or sticker.
Handling SpillsGloves DoubleGownShoe CoversMaskGogglesSpill Kit Follow instructions on spill kit package.
Deactivating, decontaminating, cleaning, and disinfectingGloves DoubleWipe
Deactivate, decontaminate, clean, and disinfect area and equipment after use and between HazDs by wiping twice with Peridox® RTU and allow a 3-minute dwell time after the second wipe. Follow wiping with 70% Isopropyl Alcohol.

Injectable Sterile Preparation-Group 1 (OH)
HandlingGloves
(ASTM D6978)
Gown
(Fluid resistant, ASTM rated)
Shoe Covers
(white polyethylene)
Mask
(N95)
Head CoverEye ProtectionPreparation HoodCSTDNotes/Instructions
Preparation/Compounding
in Pharmacy (manipulation)
Gloves Double
(outer gloves should be sterile)

GownGown
(outer gown should be chemo rated)
Shoe Covers DoubleMask Surgical

Hair CoverHair Cover
Biohazard HoodClosed System Transfer
  • Perform sterile compounding in a C-PEC utilizing aseptic technique.
  • A disposable chemo prep pad may be used when compounding within a C-PEC (BSC/CACI), however one MUST be used when compounding within a PEC (LFWB/CACI).
  • Tubing for HazD sterile products should be primed in the pharmacy with the primary fluid, with the exception of HazDs that, according to their AoR, do not have to be primed, and titratable HazDs that should be primed with active drug.
  • CSTDs should be used when compounding HazDs when the dosage form allows
  • Any second layer PPE should be removed/discarded prior to exiting the C-PEC
DecontaminatingGloves DoubleGownShoe Covers DoubleMaskHair Cover

Decontaminate finished product prior to removing from the C-PEC (Best Practice)

  • At the conclusion of compounding/manipulation, doff the outer gloves inside of the C-PEC.
  • Place the gloves into a sealable receptacle or resealable plastic bag (located in the C-PEC) with yellow (chemotherapy, cytotoxic) HazD label or sticker. The receptacle or resealable clear plastic bag will be disposed of as yellow trace RCRA waste.
  • Wipe the finished product with Peridox®RTU followed by sIPA and place on cleanest side of the C-PEC deck.
  • Wipe the inner gloved hands with Peridox®RTU prior to removing finished product form the C-PEC.
  • Remove finished product from the C-PEC, label, and place into a resealable clear plastic bag with yellow (chemotherapy, cytotoxic) HazD labeling or sticker.
  • Prior to donning second pair of gloves, sanitize inner gloved hands by applying 70% Isopropyl Alcohol (sIPA), rub gloved hands together, and allow to dry.
Handling SpillsGloves DoubleGownShoe Covers DoubleMask
GogglesSpill Kit Follow instructions on spill kit package

Transport:
Group 1 (OH)
Dosage FormTransport Within PharmacyTransport to Area(s) Within FacilityTransport to Holding Area For Patient Pick-up.
(Retail/Specialty Pharmacies Only)
Transport to Off-site Administration AreasShip Prescription Product to Locations Outside of Entity
(Retail/Specialty Pharmacies Only)
Oral Solid (intact)Gloves Single
Transport in appropriate resealable clear plastic bag or bin to reduce risk of breakage, and facilitate spill containment.
 Gloves SingleDo Not Tube
  • Transport in appropriate resealable clear plastic bag with yellow (chemotherapy, cytotoxic) HazD labeling or sticker.
  • Pneumatic Tube NOT allowed.
Gloves SingleDo Not Tube
  • Transport in appropriate resealable clear plastic bag with yellow (chemotherapy, cytotoxic) HazD labeling or sticker.
  • Pneumatic Tube NOT allowed.
Refer to OHS.PHARM.SOP.054 USP 800:  Hazardous Drug (HazD) Transport Ensure that labels and accessory labeling for the HazD include storage, disposal, and HazD category information in a format consistent with carrier's policy.
Oral Solid (manipulated)Gloves Double
Transport in appropriate resealable clear plastic bag or bin to reduce risk of breakage, and facilitate spill containment.
Gloves DoubleDo Not Tube
  • Transport in appropriate resealable clear plastic bag with yellow (chemotherapy, cytotoxic) HazD labeling or sticker.
  • Pneumatic Tube NOT allowed.
Gloves DoubleDo Not Tube
  • Transport in appropriate resealable clear plastic bag with yellow (chemotherapy, cytotoxic) HazD labeling or sticker.
  • Pneumatic Tube NOT allowed.
Refer to OHS.PHARM.SOP.054 USP 800:  Hazardous Drug (HazD) Transport Ensure that labels and accessory labeling for the HazD include storage, disposal, and HazD category information in a format consistent with carrier's policy.
Oral LiquidGloves Double
Transport in appropriate resealable clear plastic bag or bin to reduce risk of breakage, and facilitate spill containment.
Gloves DoubleDo Not Tube
  • Transport in appropriate resealable clear plastic bag with yellow (chemotherapy, cytotoxic) HazD labeling or sticker.
  • The bag must be placed into a hard-sided closable container that reduces the risk of breakage, and facilitates spill containment. 
  • The container must be clearly marked with the appropriate hazardous drug label or sticker.
  • Pneumatic Tube NOT allowed.
Gloves DoubleDo Not Tube
  • Transport in appropriate resealable clear plastic bag with yellow (chemotherapy, cytotoxic) HazD labeling or sticker.
  • The bag must be placed into a hard-sided closable container that reduces the risk of breakage, and facilitates spill containment.
  • The container must be clearly marked with appropriate
  • Pneumatic Tube NOT allowed.
Refer to OHS.PHARM.SOP.054 USP 800:  Hazardous Drug (HazD) Transport Ensure that labels and accessory labeling for the HazD include storage, disposal, and HazD category information in a format consistent with carrier's policy.
InjectableGloves Double
Transport in appropriate resealable clear plastic bag or bin to reduce risk of breakage, and facilitate spill containment.
Gloves DoubleDo Not Tube
  • Transport in appropriate resealable clear plastic bag with yellow (chemotherapy, cytotoxic) HazD labeling or sticker.
  • If HazD is in liquid form or has been manipulated, resealable plastic bag must be placed into a hard-sided closable container that reduces the risk of breakage, and facilitates spill containment.
  • The container must be clearly marked with the appropriate hazardous drug label or sticker.
  • Pneumatic Tube NOT allowed.
Gloves DoubleDo Not Tube
  • Transport in appropriate resealable clear plastic bag with yellow (chemotherapy, cytotoxic) HazD labeling or sticker.
  • If HazD is in liquid form or has been manipulated, resealable plastic bag must be placed into a hard-sided closable container that reduces the risk of breakage, and facilitates spill containment.
  • The container must be clearly marked with appropriate hazardous drug label or sticker.
  • Pneumatic Tube NOT allowed.
Refer to OHS.PHARM.SOP.054 USP 800:  Hazardous Drug (HazD) Transport Ensure that labels and accessory labeling for the HazD include storage, disposal, and HazD category information in a format consistent with carrier's policy.
Topical gel/cream/powder, suppository, vaginal inserts/creams, transdermal, subcutaneous implant.Gloves Double
Transport in appropriate resealable clear plastic bag or bin to reduce risk of breakage, and facilitate spill containment.
Gloves DoubleDo Not Tube
  • Transport in appropriate resealable clear plastic bag with yellow (chemotherapy, cytotoxic) HazD labeling or sticker.
  • If HazD is in liquid form or has been manipulated, resealable plastic bag must be placed into a hard-sided closable container that reduces the risk of breakage, and facilitates spill containment.
  • The container must be clearly marked with appropriate hazardous drug label or sticker.
  • Pneumatic Tube NOT allowed.


Gloves DoubleDo Not Tube
  • Transport in appropriate resealable clear plastic bag with yellow (chemotherapy, cytotoxic) HazD labeling or sticker.
  • If HazD is in liquid form or has been manipulated, resealable plastic bag must be placed into a hard-sided closable container that reduces the risk of breakage, and facilitates spill containment.
  • The container must be clearly marked with appropriate hazardous drug label or sticker.
  • Pneumatic Tube NOT allowed.
Refer to OHS.PHARM.SOP.054 USP 800:  Hazardous Drug (HazD) Transport Ensure that labels and accessory labeling for the HazD include storage, disposal, and HazD category information in a format consistent with carrier's policy.

Ochsner Health Guide for Oral Solid Hazardous Drugs

Ochsner Health Guide for Oral Liquid Hazardous Drugs

Ochsner Health Guide for Injectable Hazardous Drugs

Ochsner Health Guide for (Topical, Suppository, Transdermal Patches, Subcutaneous Implants)Hazardous Drugs


Assessment of Risk:
Dosage FormRisk of ExposurePackagingPharmacyNursingRisk Level
IM (prefilled syringe)May occur during preparation or administrationPrefilled syringe in carton
  • Minimal risk to pharmacy unless manipulate or unless package is damaged and leak. 
  • Dispense in original container
  • In preparation, follow mfg FDA-approved instructions, while utilizing PPE in administration guide
  • Nurse will not touch the medication during preparation or administration
Medium


Mechanism of Action:

Fulvestrant competitively and reversibly binds to estrogen receptors present in cancer cells and achieves its anti-estrogen effects through two separate mechanisms. First, fulvestrant binds to the receptors and downregulates them so that estrogen is no longer able to bind to these receptors. Second, fulvestrant degrades the estrogen receptors to which it is bound. Both of these mechanisms inhibit the growth of tamoxifen-resistant as well as estrogen-sensitive human breast cancer cell lines.

Reference: Drug Bank

Exposure Risk:

  • Harmful if swallowed
  • Causes serious eye irritation 
  • May damage fertility or the unborn child 
  • May cause harm to breast-fed children 
  • Causes damage to organs through prolonged or repeated exposure
Reference: PubChem

Approved on November 22, 2024