pasireotide

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Trade Name(s): Signifor
Group 3: Reproductive Hazard AHFS Class: Somatostatin Agonists
Formweb: pasireotide
Info Links: Chemotherapy Extravasation Policy
Injectable = vial, syringe, IV solution, irrig solution, ampule - NN & RR (LH))
ActivityGloveGownEyeMask (N95/PAPR)CSTD
AdministrationGloves Single

Goggles

If splashing

possible

Mask

If inhalation

possible

Waste/Disposal of drugGloves Single

Goggles

If splashing

possible

Mask

If inhalation

possible

Nursing Non-Antineoplastic or Reproductive Risk Drug PPE and Work Practices (Link to a file uploaded to Rhazdrugs or to a file on your intranet, or a shared drive.)

NN & RR - PPE During Handling of Bodily Fluids, contaminated materials (LH)

Handling of bodily fluids and/or contaminated materials

Drug FormGloveGownEyeMask (N95/PAPR)Shoe
Intact tablet or capsule from UD packageGloves Single
Non-intact, repackaged tablet or capsuleGloves Single
Oral liquid drug or feeding tubeGloves Single
Topical drugGloves DoubleGown
If splashing
possible
Goggles
If splashing
possible
Mask
If inhalation
possible
Powder, solution for inhalationGloves SingleGownGoggles
Mask
Vial; ampule; pre-filled syringeGloves SingleGoggles
If splashing
possible
Mask
If inhalation
possible
Intravenous solutionsGloves SingleGoggles
If splashing
possible
Mask
If inhalation
possible
Irrigation solutionsGloves SingleGoggles
If splashing
possible
Mask
If inhalation
possible


Non-antineoplastics & Reproductive Risk Only Drugs (LH)

Receiving and Storage:
NN & RR-Receiving & Storage (LH)
Form      Receipt PackagingEnvironmentGloveStorageLabeling
All FormsNo additional actionNo additional actionGloves SingleMay be stored within normal inventory, neutral or positiveCautionary Labeling

Pharmacy Non-Antineoplastic or Reproductive Risk Drugs PPE and Work Practices

Injectable NN & RR (LH)
GloveGownEyeResp ShoeHeadHood/CabinetCSTD
Gloves Double
(outer layer should be sterile)
GownMask SurgicalShoe CoversHair Cover

Laminar Air Flow Hood

LAFW

Pharmacy Non-Antineoplastic or Reproductive Risk Drugs PPE and Work Practices

Transport of NN & RR (LH)
FormPrep Instructions

Pneumatic

Tube

Intact tablet/capsule from UD packageSealed plastic bag, single pair of gloves, cautionary labelingTube Ok
Non-intact, repackaged tablet or capsuleSealed plastic bag, single pair of gloves, cautionary labeling
Tube Ok
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
Tube Ok
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

Assessment of Risk:
Dosage FormRisk of ExposurePackagingPharmacyNursingRisk Level
Intramuscular injection (LAR)May occur during preparation and administrationInjection, powder, for suspension; KitPharmacy will dispense in manufacturer's packagingUtilizing recommended PPE nurse will prepare and administer dose while avoiding direct contact with the medicationMedium
Subcutaneous injectionMay occur during preparation and administrationSingle dose glass ampulePharmacy will dispense in ampule formUtilizing recommended PPE nurse will prepare and administer dose while avoiding direct contact with the medicationMedium


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:

Pasireotide activates a broad spectrum of somatostatin receptors, exhbiting a much higher binding affinity for somatostatin receptors 1, 3, and 5 than octreotide in vitro, as well as a comparable binding affinity for somatostatin receptor 2. The binding and activation of the somatostatin receptors causes inhibition of ACTH secretion and results in reduced cortisol secretion in Cushing's disease patients. Also this agent is more potent than somatostatin in inhibiting the release of human growth hormone (HGH), glucagon, and insulin.

Reference: Drug Bank

Exposure Risk:

  • Causes skin irritation
  • Causes serious eye irritation
  • Suspected of damaging fertility or the unborn child

Reference: PubChem

Supplemental Information:

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