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 RAs1,4-8
  • SUSTOL had no significant effect on any electrocardiogram interval, including QTc duration, in clinical trials1

Due to the SUSTOL polymer, injection site reactions (ISRs) are expected but generally manageable

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 ISRs9
    • 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.
  • Modified Absorption of Granisetron In the Prevention of CINV.
  • The placebo subcutaneous injection for Study 1 was normal saline and for Study 2 was a SUSTOL-matched control consisting of the polymer vehicle without active drug.
  • All groups received dexamethasone.

5-HT3 RA=5-hydroxytryptamine receptor antagonist; IV=intravenous.

INDICATION

SUSTOL is indicated 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.

IMPORTANT SAFETY INFORMATION

Contraindications

SUSTOL is contraindicated in patients with hypersensitivity to granisetron, any of the components of SUSTOL, or any other 5-HT3 receptor antagonist.

Warnings and Precautions

Injection site reactions (ISRs), including infection, bleeding, pain and tenderness, nodules, swelling, and induration, have occurred with SUSTOL. Monitor for ISRs following SUSTOL injection. Inform patients that some ISRs may occur 2 weeks or more after SUSTOL administration. In patients receiving antiplatelet agents or anticoagulants, consider the increased risk of bruising or severe hematoma prior to the use of SUSTOL.

Monitor for constipation and decreased bowel activity and consider optimizing patients’ current bowel regimens used for managing preexisting constipation. Instruct patients to seek immediate medical care if signs and symptoms of ileus occur.

Hypersensitivity reactions have been reported and may occur up to 7 days or longer following SUSTOL administration and may have an extended course. If a reaction occurs, administer appropriate treatment and monitor until signs and symptoms resolve.

Serotonin syndrome has been reported with 5-HT3 receptor antagonists alone but particularly with concomitant use of serotonergic drugs.

Use in Specific Populations

Avoid SUSTOL in patients with severe renal impairment. In patients with moderate renal impairment, administer SUSTOL not more frequently than once every 14 days.

Adverse Reactions

Most common adverse reactions (≥3%) are injection site reactions, constipation, fatigue, headache, diarrhea, abdominal pain, insomnia, dyspepsia, dizziness, asthenia, and gastroesophageal reflux.

Report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Report side effects to Heron at 1-844-437-6611.

Please see full Prescribing Information, including Medication Guide.

References:
  1. SUSTOL [prescribing information]. Heron Therapeutics, Inc., 2017.
  2. Data on File [C2006-01]. Heron Therapeutics, Inc.
  3. Gabrail et al. Cancer Manag Res. 2015.
  4. Aloxi [prescribing information]. Helsinn Therapeutics (U.S.), Inc., 2020.
  5. Zofran [prescribing information]. GlaxoSmithKline. 2017.
  6. Kytril [prescribing information]. Genentech, Inc., 2011.
  7. Sancuso [prescribing information]. Kyowa Kirin, Inc., 2020.
  8. Anzemet [prescribing information]. Validus Pharmaceuticals LLC, 2016.
  9. Data on File [Summary of Clinical Safety]. Heron Therapeutics, Inc., San Diego, CA.




INDICATION

SUSTOL is indicated 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.

IMPORTANT SAFETY INFORMATION

Contraindications

SUSTOL is contraindicated in patients with hypersensitivity to granisetron, any of the components of SUSTOL, or any other 5-HT3 receptor antagonist.

Warnings and Precautions

Injection site reactions (ISRs), including infection, bleeding, pain and tenderness, nodules, swelling, and induration, have occurred with SUSTOL. Monitor for ISRs following SUSTOL injection. Inform patients that some ISRs may occur 2 weeks or more after SUSTOL administration. In patients receiving antiplatelet agents or anticoagulants, consider the increased risk of bruising or severe hematoma prior to the use of SUSTOL.

Monitor for constipation and decreased bowel activity and consider optimizing patients’ current bowel regimens used for managing preexisting constipation. Instruct patients to seek immediate medical care if signs and symptoms of ileus occur.

Hypersensitivity reactions have been reported and may occur up to 7 days or longer following SUSTOL administration and may have an extended course. If a reaction occurs, administer appropriate treatment and monitor until signs and symptoms resolve.

Serotonin syndrome has been reported with 5-HT3 receptor antagonists alone but particularly with concomitant use of serotonergic drugs.

Use in Specific Populations

Avoid SUSTOL in patients with severe renal impairment. In patients with moderate renal impairment, administer SUSTOL not more frequently than once every 14 days.

Adverse Reactions

Most common adverse reactions (≥3%) are injection site reactions, constipation, fatigue, headache, diarrhea, abdominal pain, insomnia, dyspepsia, dizziness, asthenia, and gastroesophageal reflux.

Report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Report side effects to Heron at 1-844-437-6611.

Please see full Prescribing Information, including Medication Guide.