SUSTOL—robust safety profile in clinical studies involving >2400 patients1-3

Adverse reactions in ≥3% in SUSTOL-treated patients during two trials. SUSTOL had no significant effect on any electrocardiogram interval in clinical trials
  • Most side effects seen with SUSTOL are consistent with what is expected of 5-HT3 RAs4,6-10
  • SUSTOL had no significant effect on any electrocardiogram interval, including QTc duration, in clinical trials4

Due to the unique polymer delivery system of SUSTOL, injection site reactions (ISRs) are expected but generally manageable4,5

Injection site reactions (ISRs) following a single 10 mg SUSTOL dose. Fewer than 1% of patients discontinued treatment due to ISRs
  • Three percent of patients receiving SUSTOL reported severe ISRs11
    • Fewer than 1% of patients discontinued treatment due to ISRs
    • Frequency and severity of most ISRs decreased in subsequent cycles
  • All reactions occurring at ≥3% in the SUSTOL group.4
  • Modified Absorption of Granisetron In the Prevention of CINV.12
  • The placebo subcutaneous injection for Study 1 was normal saline; for Study 2 it was a SUSTOL-matched control (the polymer vehicle without active drug).4
  • All groups received dexamethasone.4

5-HT3 RA=5-hydroxytryptamine 3 receptor antagonist; IV=intravenous; QTc=corrected QT interval.

References:

  1. Gabrail, et al. Cancer Manag Res. 2015.
  2. Data on File [C2006-01]. Heron Therapeutics, Inc.
  3. Data on File [C2013-01]. Heron Therapeutics, Inc.
  4. SUSTOL [prescribing information]. Heron Therapeutics, Inc., 2023.
  5. Schnadig, et al. Future Oncol. 2016.
  6. Aloxi [prescribing information]. Helsinn Therapeutics (U.S.), Inc., 2020.
  7. Zofran [prescribing information]. GlaxoSmithKline, 2017.
  8. Kytril [prescribing information]. Genentech, Inc., 2011.
  9. Sancuso [prescribing information]. Kyowa Kirin, Inc., 2022.
  10. Anzemet [prescribing information]. Validus Pharmaceuticals LLC, 2021.
  11. Data on File [Summary of Clinical Safety]. Heron Therapeutics, Inc.
  12. Smith, et al. Cancer Nurs. 2019.