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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. SUSTOL is a serotonin-3 (5-HT 3 ) receptor antagonist 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. ( 1 )

is contraindicated in patients with hypersensitivity to granisetron, any of the components of SUSTOL, or to any of the other 5-HT 3 receptor antagonists [see Warnings and Precautions ( 5.3 ), Description ( 11 )] . Hypersensitivity to granisetron, any of the components of SUSTOL, or to any of the other 5-HT 3 receptor antagonists. ( 4 , 5.3 )

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. ( 5.1 ) Gastrointestinal disorders: Monitor for constipation and consider optimizing patients' current bowel regimens used for managing preexisting constipation. Also monitor for decreased bowel activity, particularly in patients with risk factors for gastrointestinal obstruction. Instruct patients to seek immediate medical care if signs and symptoms of ileus occur. ( 5.2 ) Hypersensitivity reactions: Serious 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. ( 5.3 ) Serotonin syndrome: Reported with 5-HT receptor antagonists alone but particularly with concomitant use of serotonergic drugs. If such symptoms occur, discontinue SUSTOL and initiate supportive treatment. If concomitant use of SUSTOL with other serotonergic drugs is clinically warranted, patients should be made …

8.1 Pregnancy Risk Summary There are no available data on the use of SUSTOL in pregnant women. Limited published data on granisetron use during pregnancy are not sufficient to inform a drug-associated risk. In animal reproduction studies, no adverse developmental effects were observed in pregnant rats and rabbits administered granisetron hydrochloride during organogenesis at intravenous doses up to 61 times and 41 times respectively the maximum recommended human dose (MRHD) of SUSTOL 10 mg/week [see Data] . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other …