For Patients Full Prescribing Information With Medication Guide IFU Important Safety Information Contact a Representative

SUSTOL represents the latest formulation of injectable, single-agent 5-HT₃ RAs^1-5

Timeline of 5-HT3 RAs leading to SUSTOL

SUSTOL protects your patients during both the acute and delayed phases

SUSTOL is the first and only extended-release 5-HT₃ RA that utilizes polymer technology^1-3,6-8
Palonosetron is not indicated for prevention of delayed CINV associated with HEC¹

Why choosing the right 5-HT₃ RA is important

Consequences of uncontrolled CINV to consider:

Delays or discontinuation of future chemotherapy cycles^9,10
Impact on quality of life by increasing the potential for hospitalizations and unscheduled visits for hydration^11,12
Risk for medical complications such as malnutrition, weight loss, and electrolyte imbalances^11,12
Additional treatment, including reliance on rescue medications¹¹

Earlier 5-HT₃ RA formulations with a shorter duration of action may not protect patients from both acute and delayed CINV^1-3

5-HT₃ RA=5-hydroxytryptamine receptor antagonist; CINV=chemotherapy-induced nausea and vomiting; HEC=highly emetogenic chemotherapy.

Full 5-day efficacy⁶

Explore Phase 3 trial data

Robust safety profile^6,13,14

Review safety data

How well is CINV controlled?

See breakthrough CINV rates

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:

Aloxi [prescribing information]. Helsinn Therapeutics (U.S.), Inc., 2020.
Zofran [prescribing information]. GlaxoSmithKline. 2017.
Kytril [prescribing information]. Genentech, Inc., 2011.
U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Anzemet injection approval letter. October 11, 1997.
U.S. Food and Drug Administration, Center for Drug Evaluation and Research. SUSTOL injection approval letter. August 9, 2016.
SUSTOL [prescribing information]. Heron Therapeutics, Inc., 2017.
Sancuso [prescribing information]. Kyowa Kirin, Inc., 2020.
Anzemet [prescribing information]. Validus Pharmaceuticals LLC, 2016.
Van Laar et al. Support Care Cancer. 2015.
Neymark et al. Support Care Cancer. 2005.
Hawkins et al. Clin J Oncol Nurs. 2009.
Burke et al. Support Care Cancer. 2011.
Gabrail et al. Cancer Manag Res. 2015.
Data on File [C2006-01]. Heron Therapeutics, Inc.