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SUSTOL—THE FIRST AND ONLY 5-HT3 RA TO DEMONSTRATE SUPERIORITY IN A 3-DRUG VS 3-DRUG HEC TRIAL
Trial 2 (MAGIC) results: prevention of delayed CINV due to HEC
  • Complete response was defined as no emetic episodes, including retching, and no use of rescue medications.
  • 2-sided hypothesis test. Significance level at α=0.05.
  • All patients were concomitantly administered intravenous dexamethasone.
  • SUSTOL demonstrated superiority vs IV ondansetron in the prevention of delayed CINV in a trial of over 900 patients receiving HEC regimens encompassing AC, cisplatin, and other regimens1
  • A prespecified subgroup analysis of the cisplatin and non-cisplatin strata demonstrated consistent treatment benefit compared to the overall study population. However, the study was not powered to show statistical significance within subset analyses1
  • 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 established1,2
  • Data shown are not included in the SUSTOL Prescribing Information. SUSTOL is not indicated in patients treated with cisplatin
Study Description

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. Schnadig ID, Agajanian R, Dakhil C, et al. APF530 (granisetron injection extended-release) in a three-drug regimen for delayed CINV in highly emetogenic chemotherapy. Future Oncol. 2016;12:1469-1481.
  2. Data on File [C2006-01]. 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.