SUSTOL—proven 5-day CINV protection to smooth the journey

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.

  • Unique formulation provides a sustained release of granisetron that offers protection that lasts for ≥5 days1,2
  • The only 5-HT3 RA to demonstrate superiority in a Phase 3, 3-drug vs 3-drug HEC trial3
  • Unscheduled mean CINV-related hydration rate was lower for SUSTOL than for palonosetron in 2 real-world retrospective studies4,5
  • Robust safety profile in clinical studies involving >2400 patients1,6,7
SUSTOL is an NCCN Category 1 Recommended Option

Granisetron extended-release injection (SUSTOL) is a Category 1 option in the NCCN Guidelines® for the prevention of acute and delayed emesis due to HEC and MEC.*†‡§

Granisetron extended-release injection (SUSTOL) is also a preferred option in MEC when used in a combination with dexamethasone in a 2-drug antiemetic regimen.8∥

* When used in recommended antiemetic combination regimens on day 1.
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Antiemesis.
Category 1: Based upon high-level evidence, there is uniform National Comprehensive Cancer Network® (NCCN) consensus that the intervention is appropriate.
§ SUSTOL is indicated for the prevention of CINV due to MEC and AC combination chemotherapy.
See the NCCN Guidelines for detailed recommendations, including other preferred options.
5-HT3 RA=5-hydroxytryptamine receptor antagonist; AC=anthracycline/cyclophosphamide; CINV=chemotherapy-induced nausea and vomiting; HEC=highly emetogenic chemotherapy; MEC=moderately emetogenic chemotherapy; PK=pharmacokinetics.

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. Ottoboni et al. J Exp Pharmacol. 2014.
  3. Schnadig et al. Future Oncol. 2016.
  4. Vacirca et al. Future Oncol. 2018.
  5. Erickson et al. Future Oncol. 2019.
  6. Data on File [C2006-01]. Heron Therapeutics, Inc.
  7. Gabrail et al. Cancer Manag Res. 2015.
  8. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Antiemesis V.1.2021. ©National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed January 26, 2021. To view the most recent and complete version of the guideline, go to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
  9. Zhou et al. Ther Clin Risk Manag. 2015.




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.