Ondansetron (Page 8 of 8)

16 HOW SUPPLIED/STORAGE AND HANDLING

Ondansetron Injection, USP, 2 mg/mL, is available as follows:

2 mL Single Dose Vial packaged in 25s (NDC 0641-6080-25)

This product, including the packaging components, is not made with natural rubber latex.

Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from light.

To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For Product Inquiry call 1-877-845-0689.

17 PATIENT COUNSELING INFORMATION

Hypersensitivity Reactions

Inform patients that Ondansetron Injection may cause hypersensitivity reactions, some as severe as anaphylaxis and bronchospasm. The patient should report any signs and symptoms of hypersensitivity reactions, including fever, chills, rash, or breathing problems [see Warnings and Precautions (5.1)].

QT Prolongation

Patients should be informed that Ondansetron Injection may cause serious cardiac arrhythmias, such as QT prolongation. Patients should be instructed to tell their healthcare provider right away if they perceive a change in their heart rate, if they feel lightheaded, or if they have a syncopal episode.

Patients should be informed that the chances of developing severe cardiac arrhythmias, such as QT prolongation and Torsade de Pointes are higher in the following people:

• Patients with a personal or family history of abnormal heart rhythms, such as congenital long QT syndrome;

• Patients who take medications, such as diuretics, which may cause electrolyte abnormalities;

• Patients with hypokalemia or hypomagnesemia.

Ondansetron Injection should be avoided in these patients, since they may be more at risk for cardiac arrhythmias, such as QT prolongation and Torsade de Pointes [see Warnings and Precautions (5.2)].

Drug Interactions

• Instruct the patient to report the use of all medications, especially apomorphine, to their healthcare provider. Concomitant use of apomorphine and Ondansetron Injection may cause a significant drop in blood pressure and loss of consciousness.

• Advise patients of the possibility of serotonin syndrome with concomitant use of Ondansetron Injection and another serotonergic agent, such as medications to treat depression and migraines. Advise patients to seek immediate medical attention if the following symptoms occur: changes in mental status, autonomic instability, neuromuscular symptoms with or without gastrointestinal symptoms [see Warnings and Precautions (5.3)].

Myocardial Ischemia

Inform patients that Ondansetron Injection may cause myocardial ischemia during or after the administration. Advise patients to seek immediate medical help if any symptoms suggestive of a myocardial ischemia occur, such as sudden chest pain or chest tightness [see Warnings and Precautions (5.4)].

M a sking of Progressive Ileus and Gastric Distention

Inform patients following abdominal surgery or those with chemotherapy-induced nausea and vomiting that Ondansetron Injection may mask signs and symptoms of bowel obstruction. Instruct patients to immediately report any signs or symptoms consistent with a potential bowel obstruction to their healthcare provider [see Warnings and Precautions (5.5)].

Manufactured by:

Hikma Pharmaceuticals USA Inc.

Berkeley Heights, NJ 07922

Novaplus is a registered trademark of Vizient, Inc.

novaplus+

Revised April 2022 462-568-11

PRINCIPAL DISPLAY PANEL

NDC 0641-6080 -01
Rx ONLY
Ondansetron Injection, USP
For IV or IM Injection
4 mg per 2 mL (2 mg/mL)
Protect from light 2 mL Single Dose Vial

NDC 0641-6080 -25 Rx ONLY
Ondansetron Injection, USP
For Intravenous or Intramuscular Injection
4 mg per 2 mL (2 mg/mL)*25 x 2 mL Single Dose Vials

SERIALIZATION IMAGE

ONDANSETRON ondansetron injection

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0641-6080 Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ONDANSETRON HYDROCHLORIDE (ONDANSETRON) ONDANSETRON 2 mg in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE 9 mg in 1 mL CITRIC ACID MONOHYDRATE 0.5 mg in 1 mL TRISODIUM CITRATE DIHYDRATE 0.25 mg in 1 mL WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0641-6080-25 25 VIAL in 1 CARTON contains a VIAL (0641-6080-01) 1 NDC:0641-6080-01 2 mL in 1 VIAL This package is contained within the CARTON (0641-6080-25)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077541 12/26/2006

Labeler — Hikma Pharmaceuticals USA Inc. (946499746)

Registrant — Hikma Pharmaceuticals USA Inc. (001230762)

Revised: 04/2022 Hikma Pharmaceuticals USA Inc.