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SUSTOL—proven 5-day CINV prevention*
Learn about 5-day efficacy
SUSTOL acute CINV and delayed CINV results
Study Description
*SUSTOL is indicated for the prevention of CINV due to MEC and AC combination chemotherapy.1
Due to the number of cisplatin-treated patients in SUSTOL Phase 3 clinical trials (n=358; 26% of HEC-treated patients), efficacy in this population has not been established. CR rates for all HEC-treated patients in Trial 1 were: acute phase (SUSTOL 75% vs palonosetron 67%; noninferiority achieved) and delayed phase (SUSTOL 56% vs palonosetron 51%; superiority not achieved); these data are not included in SUSTOL Prescribing Information. SUSTOL is not indicated in patients treated with cisplatin.2-5
This study was designed to show noninferiority in the acute phase or delayed phase for patients receiving MEC and in the acute phase for patients receiving HEC. A lower bound greater than -15% demonstrates noninferiority between SUSTOL and comparator. MEC: acute phase 95% confidence interval (CI) SUSTOL vs palonosetron: -13, 1; delayed phase 95% CI: -10, 8. AC-based HEC regimens: acute phase 95% CI SUSTOL vs palonosetron: -3, 17; delayed phase 95% CI: -9, 13.
||All patients were concomitantly administered intravenous dexamethasone.

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.

For more information about SUSTOL, please see full Prescribing Information.

References:
  1. SUSTOL [package insert]. Heron Therapeutics, Inc., Redwood City, CA; August 2016.
  2. Data on File [C2006-01]. Heron Therapeutics, Inc., Redwood City, CA.
  3. Raftopoulos H, Boccia R, Cooper W, O'Boyle E, Gralla RJ. Slow-release granisetron (APF530) versus palonosetron for chemotherapy-induced nausea/vomiting: analysis by American Society of Clinical Oncology emetogenicity criteria. Future Oncol. 2015;11:2541-2551.
  4. Raftopoulos H, Cooper W, O'Boyle E, Gabrail N, Boccia R, Gralla RJ. Comparison of an extended-release formulation of granisetron (APF530) versus palonosetron for the prevention of chemotherapy-induced nausea and vomiting associated with moderately or highly emetogenic chemotherapy: results of a prospective, randomized, double-blind, noninferiority phase 3 trial. Support Care Cancer. 2015;23:723-732.
  5. Data on File [C2013-01]. Heron Therapeutics, Inc., Redwood City, 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.

For more information about SUSTOL, please see full Prescribing Information.