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.
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
Serious or severe injection site reactions (ISRs): infection, prolonged bleeding, bruising,
hematomas, nodules, pain, and tenderness have been reported. Patients who are neutropenic or
receiving antiplatelet agents or anticoagulants may be at greater risk. Monitor for ISRs during
treatment with SUSTOL. Inform patients that some ISRs may occur 2 weeks or more after SUSTOL
administration. For ongoing ISRs, administer SUSTOL at a site away from the affected area and
consider discontinuing SUSTOL for severe or persistent ISRs.
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 . Report side effects to
Heron at 1-844-437-6611.
