Ondansetron Injection is a 5-HT3 receptor antagonist indicated for the prevention of:

• nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy. (1.1)
• postoperative nausea and/or vomiting. (1.2)

Prevention of Nausea and Vomiting Associated With Initial and Repeat Courses of Emetogenic Cancer Chemotherapy (2.1):

• Dilution of Ondansetron Injection in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection is required before administration to adult and pediatric patients.
• Adults and pediatric patients 6 months of age and older: The recommended dosage is 0.15 mg/kg per dose for 3 doses (maximum of 16 mg per dose), infused intravenously over 15 minutes.
• Administer the first dose 30 minutes before the start of chemotherapy and subsequent doses 4 and 8 hours after the first dose.

Prevention of Postoperative Nausea and/or Vomiting (2.2):

• Dilution of Ondansetron Injection is not required before administration to adult and pediatric patients.
• See full prescribing information for the recommended dosage and administration instructions for adult and pediatric patients 1 month of age and older.

Patients With Severe Hepatic Impairment (2.3):

• Do not exceed a total daily dose of 8 mg.

Injection: 2 mL single-dose vial and 20 mL multiple-dose vial. (3)

• Patients known to have hypersensitivity (e.g., anaphylaxis) to this product or any of its components. (4)
• Concomitant use of apomorphine. (4, 7.2)

• Hypersensitivity Reactions: Hypersensitivity reactions, including anaphylaxis and bronchospasm have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists. (5.1)
• QT Prolongation and Torsade de Pointes: QT prolongation occurs in a dose-dependent manner. Cases of Torsade de Pointes have been reported. Avoid ondansetron in patients with congenital long QT syndrome. (5.2)
• Serotonin Syndrome: Serotonin syndrome has been reported with 5-HT3 receptor agonists alone but particularly with concomitant use of serotonergic drugs. (5.3)
• Myocardial Ischemia: Do not exceed the recommended infusion rate and monitor patients during and after administration. (2.1, 2.2, 5.4)
• Masking of Progressive Ileus and/or Gastric Distension Following Abdominal Surgery or Chemotherapy-Induced Nausea and Vomiting: Monitor for decreased bowel activity, particularly in patients with risk factors for gastrointestinal obstruction. (5.5)

Chemotherapy-Induced Nausea and Vomiting:

• The most common adverse reactions (≥ 7%) in adults are diarrhea, headache, and fever. (6.1)

Postoperative Nausea and/or Vomiting:

• The most common adverse reaction (≥ 10%) which occurs at a higher frequency compared with placebo in adults is headache. (6.1)
• The most common adverse reaction (≥ 2%) which occurs at a higher frequency compared with placebo in pediatric patients aged 1 to 24 months is diarrhea. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.