zoledronic acid

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Trade Name(s): Zoledronic Acid; Zometa
Group 3: Reproductive Hazard AHFS Class: Bone Resorption Inhibitors
Preparation:
Injectable (IM, SubQ, IV, IR, etc.) - 2&3
ActionGlovesGownEye/FaceMask
CSTD
Dispensing prepackaged formulations




  • PPE not required if dispensed in manufacturer packaging with no counting or manipulation needed.
Preparing an Injectable Dose Gloves DoubleGownFace Shield
If risk of spill or splash		Mask
If risk of inhalation		Closed System Transfer
If dosage form allows
  • CSTDs known to be physically or chemically incompatible with a specific HD must not be used for that hazardous drug.
Administration:
Injectable (IM, SubQ, IV, IR, etc.) - 2&3
FormulationGloves
GownEye/Face
MaskCSTD
Prepared injectable (vial, syringe, IV solution*, irrigation**)Gloves Single
or
Gloves Double
Recommended if pregnant, breast feeding, or trying to conceive
Gown
If splash possible or recommended if pregnant, breast feeding, or trying to conceive		Face Shield
If splash possible or recommended if pregnant, breast feeding, or trying to conceive		Mask
Recommended if pregnant, breast feeding, or trying to conceive
Closed System Transfer
If dosage form allows
Manufacturer packaged pre-filled syringe or injectorGloves Single
or
Gloves Double 
Recommended if pregnant, breast feeding, or trying to conceive


Closed System Transfer
if provided in kit, or if dosage form allows

* Intravenous tubing already attached and primed.

** Bladder, HIPEC, limb perfusion, etc. 

Reference: NIOSH 2016, USP <800>


Receiving and Storage:
Storage & Handling
Type of InstanceGloves
GownMaskEye/FaceNotes/Instructions
Receiving undamaged HD shipping containerGloves Single
  • Hazardous drugs should be received in impervious plastic to segregate them from other drugs and to allow for safety in the receiving process.
  • HDs must be delivered to the HD storage area immediately after unpacking.
Receiving damaged HD shipping containerGloves Double
Gown
If container must be opened		Mask
If container must be opened		Goggles
If container must be opened
  • If possible, do not open the container. Instead, segregate the container in a segregated area and mark "hazardous." Alert other staff and contact the supplier for direction. If the container is to be returned, leave in the segregated area until the return is complete.
  • If the damaged HD container must be opened, don the appropriate PPE and transport the container to the designated HD area. Remove undamaged items, cleaning the outside of each with alcohol or hydrogen peroxide. Enclose the damaged HD item(s) in a hazardous plastic bag, seal in a small shipping box marked "hazardous," and place in a segregated area. Clean the designated HD area where the container was handled. Contact the supplier for direction.
  • If the supplier declines return, dispose of as hazardous waste.
  • If the damaged HD in the shipping container constitutes a large volume spill, report to the USP 800 Specialist.
Spill CleanupGloves DoubleGownMask
Large volume		Goggles
Large volume		Spill Kit
  • Clear the area of the spill and restrict access, if necessary.
  • Small Volume Spills: Powder or liquid spills of 5 grams/ml or less. Clean spill using a cloth, towel or wipe dampened with alcohol or hydrogen peroxide. Do not spray cleaning product directly on to surface or spill.
  • Large Volume Spills: Powder or liquid spills of 5 grams/ml or more. Use a Chemo Spill Kit and the cleaning agents included, following the instructions in the kit. Contain liquid spills by covering with absorbent sheets. If the spill is a powder, use a cloth, towel or wipe dampened with alcohol or hydrogen peroxide. Report large volume spills to the USP 800 specialist.
  • Dispose of all contaminated materials in the appropriate hazardous drug waste container.
  • After removing PPE, wash hands, arms, and face.

Reference: USP <800>

Disposal:
Disposals - All
Hazardous PharmaceuticalTrace ChemoBiohazardous and Sharps
Black BinYellow BinRed Bin
1.  Non-returnable hazardous, chemo and EPA regulated drugs.
(Patient specific prescriptions, partially used blister packs, containers with more than 3% medication remaining)

2. Empty bottles or packaging of P-Listed drugs.
(Warfarin, nicotine, epinephrine, nitroglycerin, physostigmine)

3. PPE with visible contamination from hazardous drug.

1. Waste contaminated through contact with chemotherapeutic agents.

(Empty vials, IV bags, syringes and tubing)


2. PPE worn while handling hazardous drugs with NO visible contamination.

(Gowns, gloves and masks)


3. Used CSTD devices.

1. All sharps capable of cutting or piercing the skin.
(Needles/syringes, broken ampules, lancets)

2. Items contaminated with blood or other potentially infectious materials.
(Tubing, bags or dressings containing blood, contaminated waste from isolation patients)


Transport:
Transporting
Dosage FormShip to Institution or PharmacyShip to Locations Outside of ODOC
Tablets and CapsulesGloves Single
  • Transport in appropriate resealable clear plastic bag with "Hazardous Drug" labeling or sticker.
  • Place bagged HD in a small shipping box labeled "Hazardous" and seal.
  • Place sealed box inside larger shipping container or box and seal.
Gloves Single
  • Transport in appropriate resealable clear plastic bag with "Hazardous Drug" labeling or sticker.
  • Place bagged HD in a small shipping box labeled "Hazardous" and seal.
  • Place sealed box inside larger shipping container or box and seal.
  • Include storage, disposal, and HazD category information.
Liquid, Topical, and TransdermalGloves Double
  • Transport in appropriate resealable clear plastic bag with "Hazardous Drug" labeling or sticker.
  • Place bagged HD in a small shipping box labeled "Hazardous" and seal.
  • Place sealed box inside larger shipping container or box and seal.
Gloves Double
  • Transport in appropriate resealable clear plastic bag with "Hazardous Drug" labeling or sticker.
  • Place bagged HD in a small shipping box labeled "Hazardous" and seal.
  • Place sealed box inside larger shipping container or box and seal.
  • Include storage, disposal, and HazD category information.

PPE:
PPE Standards
PPEStandards
Shoe Covers
Shoe Covers


  • To avoid spreading HD contamination and exposing other healthcare workers, shoe covers worn in HD handling areas must not be worn to other areas.

Gown

Gowns

  • Gowns must be changed per the manufacturer's information for permeation of the gown. If no permeation information is available, change them every 2-3 hours or immediately after a spill or splash.
  • Gowns are not reusable and must be disposed of after use.
  • Must close in the back (no open front)
  • Gowns worn in hazardous drug handling areas must NOT be worn to other areas
Gloves Single
Gloves
  • Must be worn when handling all HDs
  • Inspect for physical defects before use.
  • Gloves should be changed every 30 minutes (unless otherwise recommended by the manufacturer) and immediately when torn, punctured, or contaminated.
  • Gloves must be changed in between patients when administering different HDs.
  • Wash hands with soap and water after removing.
Face Shield
Face Shields
  • Face shields should be worn in situations where eye, mouth, or nasal splashing is possible
  • Face shields can be worn with goggles to provide a full range of protection against splashes to the face and eyes.
Goggles
Goggles
  • Goggles must be used when eye protection is needed. Eye glasses, safety glasses and face shields do not provide adequate eye protection.
  • Must be worn when there is a risk for spills or splashes of HDs or HD waste materials.
Mask
N95 Masks
  • Personnel who are unpacking HDs that are not contained in plastic should wear an N95 mask until the drug can be identified.
  • Surgical masks do not provide respiratory protection from HD exposure and must not be used.
  • N95 respirators offer no protection against gases and vapors and little protection against direct liquid splashes.
  • Follow all requirements in the Occupational Safety and Health Administration (OSHA) respiratory protection standard (29 CFR 1910.134).
Removal and Disposal
  • All PPE worn when handling HDs is considered contaminated.
  • Remove gloves first, grasping the outside of the glove with the opposite gloved hand.
  • Hold the removed glove in the gloved hand. Slide the fingers of the ungloved hand under the remained glove at wrist. Peel second glove over the first glove.
  • If wearing double glove, remove the outer gloves one at a time, turning them carefully inside out to avoid touching the outside. Leave inner gloves on.
  • The face shield, if worn, should be removed next, while avoiding contact with the front. 
  • Remove the gown, using care to pull it away from the body, not pulling it over the head, to avoid transfer of contamination to clothes and skin. Turn the gown inside out, fold it tightly, and discard it.
  • Remove the mask (if worn), avoiding touching the face-piece. 
  • Remove inner gloves (if double gloved) and discard in the disposal container. 
  • Immediately wash hands with soap and water. .
  • PPE must be placed in an appropriate waste container and further disposed of per local, state, and federal regulations.

Reference: USP <800>

Assessment of Risk:

AoR

Exposure Risk:

  • Causes skin irritation. 
  • Causes serious eye irritation. 
  • May cause respiratory irritation

Reference: SDS - Cayman Chemical

Supplemental Information:

Only met the NIOSH criteria as a developmental and/or reproductive hazard

Mechanism of Action:

The action of zoledronate on bone tissue is based partly on its affinity for hydroxyapatite, which is part of the mineral matrix of bone. Zoledronate also targets farnesyl pyrophosphate (FPP) synthase. Nitrogen-containing bisphosphonates such as zoledronate appear to act as analogues of isoprenoid diphosphate lipids, thereby inhibiting FPP synthase, an enzyme in the mevalonate pathway. Inhibition of this enzyme in osteoclasts prevents the biosynthesis of isoprenoid lipids (FPP and GGPP) that are essential for the post-translational farnesylation and geranylgeranylation of small GTPase signalling proteins. This activity inhibits osteoclast activity and reduces bone resorption and turnover. In postmenopausal women, it reduces the elevated rate of bone turnover, leading to, on average, a net gain in bone mass.

Reference: Drug Bank

Safety Data Sheet(s):
Source References:

DrugBank

NIH DailyMed

NIH PubChem

FDA Medication Guides

FDA Specific Drug Information

NIOSH Documents:

Approved on January 8, 2024