• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Directories » FDA Approved Drugs » Sustol (granisetron)

AND
  • A
  • B
  • C
  • D
  • E
  • F
  • G
  • H
  • I
  • J
  • K
  • L
  • M
  • N
  • O
  • P
  • Q
  • R
  • S
  • T
  • U
  • V
  • W
  • X
  • Y
  • Z

Sustol (granisetron)

  • Profile

Profile

Contact Information

Contact: Heron Therapeutics
Website: http://www.sustol.com/

Currently Enrolling Trials

    Show More

    General Information

    Sustol (granisetron) is a serotonin-3 (5-HT3) receptor antagonist.

    Sustol is specifically indicated for use in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. 

    Mechanism of Action

    Sustol (granisetron) is a serotonin-3 (5-HT3) receptor antagonist. Serotonin receptors of the 5-HT3 type are located peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone of the area postrema. During chemotherapy that induces vomiting, mucosal enterochromaffin cells release serotonin, which stimulates 5-HT3 receptors. This evokes vagal afferent discharge, inducing vomiting. Animal studies demonstrate that, in binding to 5-HT3 receptors, granisetron blocks serotonin stimulation and subsequent vomiting after emetogenic stimuli such as cisplatin.

    Side Effects

    Adverse effects associated with the use of Sustol may include, but are not limited to, the following: 

    • injection site reactions
    • constipation
    • fatigue
    • headache
    • diarrhea
    • abdominal pain
    • insomnia
    • dyspepsia
    • dizziness
    • asthenia
    • gastroesophageal reflux

    Dosing/Administration

    Sustol is supplied as an extended-release injection for subcutaneous use. The recommended dose in adults is 10 mg administered as a single subcutaneous injection at least 30 minutes before the start of emetogenic chemotherapy on day 1.

    • Do not administer Sustol more frequently than once every seven days.
    • Use of Sustol with successive emetogenic chemotherapy cycles for more than six months is not recommended.
    • See full prescribing information for recommended dosage of concomitant dexamethasone.

    Clinical Trial Results

    The FDA approval of Sustol was based on a randomized, multicenter, double-blind, parallel group study. A single 10 mg subcutaneous dose of Sustol was compared to a single 0.25 mg intravenous dose of palonosetron hydrochloride in cancer patients administered moderately emetogenic (MEC) or anthracycline plus cyclophosphamide (AC) combination chemotherapy. Sustol or palonosetron hydrochloride was administered 30 minutes prior to chemotherapy on day 1. Patients also received either 8 or 20 mg intravenous dexamethasone on day 1 depending on chemotherapy regimen. Patients who received 20 mg of intravenous dexamethasone also received oral dexamethasone 8 mg twice daily on Days 2, 3 and 4. The primary endpoints were proportion of patients with complete response (CR) [defined as no emetic episodes (vomiting or retching) and no use of rescue medication] during the acute phase (0 to 24 hours) and the delayed phase (>24 to 120 hours) following the administration of chemotherapy in cycle 1. The study design allowed for assessment of non-inferiority of Sustol to palonosetron hydrochloride in the acute and delayed phase of MEC and of AC combination chemotherapy. Non-inferiority of Sustol to palonosetron hydrochloride was demonstrated in the acute and delayed phases of MEC and of AC combination chemotherapy.

     

    Approval Date: 2016-08-01
    Company Name: Heron Therapeutics
    Back to Listings

    Upcoming Events

    • 24May

      Powering an Effective Oversight Strategy with Clinical and Operational Insights

    • 25May

      2022 WCG Avoca Quality & Innovation Summit: Own the Future

    • 28Jun

      Effective Root Cause Analysis and CAPA Investigations for the Life Sciences

    • 16Oct

      WCG MAGI's Clinical Research Hybrid Conference - 2022 West

    Featured Products

    • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

      Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    • Surviving an FDA GCP Inspection

      Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

    Featured Stories

    • Protocol-360x240.png

      Avoid Deviations by Making Protocol Review a Team Effort

    • SelectionProcess-360x240.png

      Give Us a Voice: Sites Clamor for a Say on Vendor Selection

    • Convince-360x240.png

      Use Data and Details to Convince Site Leadership to Add Staff

    • AsktheExpertsBadge-360x240.png

      Ask the Experts: Listing Trial Staff and Others on the Statement of Investigator

    Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

    The information you need to adapt your monitoring plan to changing times.

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy
    • Do Not Sell My Personal Information

    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 617.948.5100 – Toll free 866.219.3440

    Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing