21

March

Granisetron Transdermal System Use Chemotherapy Induced Nausea and Vomiting (CINV)

Written by: Latha Radhakrishnan, PharmD, BCPS, BCOP
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Description of PQI:

The Granisetron Transdermal System is a 5-HT3 Receptor Antagonist (5-HT3 RA) that allows for an alternate medication delivery compared to oral or parenteral administration.  This can be particularly beneficial to those patients that do not have intravenous access, are unable to swallow, or have adherence issues. 

Background:

The Granisetron Transdermal System was approved in 2008 for the prevention of nausea and vomiting in patients receiving moderately and/or highly emetogenic chemotherapy (MEC and/or HEC) for up to 5 consecutive days1.  The National Comprehensive Cancer Network (NCCN) Antiemesis Practice Guideline includes granisetron transdermal system/patch as a 5-HT3 RA option for use in the prevention of acute and delayed intravenous MEC and HEC chemotherapy.  It is also a choice in high to moderate chemotherapy emesis prevention2. The pharmacokinetic profile of the formulation reveals continuous delivery of granisetron through the skin for over 6 days3Boccia et. al. conducted a double-blind, phase III, non-inferiority trial comparing the efficacy and tolerability of the granisetron transdermal system to daily oral granisetron for the control of CINV.  The results revealed non-inferiority to oral granisetron.  Both granisetron formulations were well tolerated with constipation being the most common side effect4.

Based on clinical practice experience, consider using the granisetron transdermal system in the following patient situations:

  1. Moderate to highly emetogenic multi-day chemotherapy
  2. Difficulty swallowing tablets due to oral mucositis, tumor location, vomiting, etc.
  3. Combination radiation + chemotherapy (head and neck regimens, etc.)
  4. Limited gut motility and absorption due to opioids or tumor location
  5. Difficulty remembering to take oral medications
  6. Refractory nausea and vomiting despite receiving appropriate preventative anti-emetics
    • Place patch on patients on the last day of multi-day intravenous chemotherapy

PQI Process:

Upon receipt of an order for granisetron transdermal system:

  • Ensure appropriateness of use in either MEC/HEC intravenous or high to moderate oral chemotherapy
  • Check start date of chemotherapy cycle
    • Apply 1 patch (3.1mg) 24-48 hours on clean, dry, intact skin on the upper outer arm prior to the start of c hemotherapy to the upper arm (do not cut)
    • Wear throughout chemotherapy treatment up to 7 days total
    • Remove at least 1 day (24 hours) after chemotherapy completed
  • Verify prescription coverage.  If issues, use Patient Rx Solutions to assist in coverage options
  • Discuss the use of surgical bandages or medical adhesive tape at the edges of the transdermal system to keep it in place
  • Provide a prescription for a rescue medication (i.e. prochlorperazine, metoclopramide, etc.) to assist with breakthrough nausea and vomiting.  Other 5-HT3 RA such as ondansetron should not be used as rescue medications to avoid QT prolongation, constipation, and headache.

Patient Centered Activities:

  • Application Instructions
    • Ensure that patients understand where to apply the patch
    • Educate on avoiding sunlight and heating sources (heating pads, tanning beds)
  • Patient Education
    • Review common side effects which include constipation and headache
      • Constipation – provide recommendations for a stimulant laxative (bisacodyl, sennosides, etc.) PLUS a stool softener
    • Explain when to apply and remove the patch – a calendar would assist
    • Remind to keep patch area covered under clothing and for another 10 days after the patch is removed to avoid potential skin reactions from natural or artificial sunlight
  • Financial Assistance
    • Patient Rx Solutions (https://www.patientrxsolutions.com or 1-800-676-5884)
      • Coverage option for uninsured patients
      • Co-pay Assistance Cards
      • Sancuso Patch Replacement Program– If chemotherapy is delayed or rescheduled

References:

  1. Sancuso [package insert, Bedminster, NJ: ProStrakan, Inc.; 2015.
  2. National Comprehensive Cancer Network. Antiemesis (Version 3.2018). https://www.nccn.org/professionals/physician_gls/pdf/antiemesis.pdf Accessed January 3, 2018.
  3. Howell J, Smeets J, Drenth H, et al. Pharmacokinetics of a granisetron transdermal system for the treatment of chemotherapy-induced nausea and vomiting. J Oncol Pharm Practice. 2009; 15: 223 – 231.
  4. Boccia RV, Gordan LN, Clark G et al. Efficacy and tolerability of transdermal granisetron for the control of chemotherapy-induced nausea and vomiting associated with moderately and highly emetogenic multi-day chemotherapy: a randomized, double-blind, phase III study. Support Care Cancer.2011; 19: 1609-1617.
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