INDICATIONS AND USAGE

Iodixanol injection is a radiographic contrast agent indicated for the following:

Intra-arterial Procedures

Adults and pediatric patients 12 years of age and over

• Intra-arterial digital subtraction angiography (270 mg Iodine/mL and 320 mg Iodine/mL).
• Angiocardiography (left ventriculography and selective coronary arteriography), peripheral arteriography, visceral arteriography, and cerebral arteriography (320 mg Iodine/mL).

Pediatric patients less than 12 years of age

• Angiocardiography, cerebral arteriography, and visceral arteriography (320 mg Iodine/mL).

Intravenous Procedures

Adults and pediatric patients 12 years of age and over

• Computed tomography (CT) imaging head and body (270 mg Iodine/mL and 320 mg Iodine/mL).
• Excretory urography (270 mg Iodine/mL and 320 mg Iodine/mL).
• Peripheral venography (270 mg Iodine/mL).
• Coronary computed tomography angiography (CCTA) to assist diagnostic evaluation of patients with suspected coronary artery disease (320 mg Iodine/mL).

Pediatric patients less than 12 years of age

• CT imaging of the head and body (270 mg Iodine/mL).
• Excretory urography (270 mg Iodine/mL).

Iodixanol is contraindicated for intrathecal use.

• Hypersensitivity Reactions: Life-threatening or fatal reactions can occur. Always have emergency equipment and trained personnel available.
• Contrast-Induced Acute Kidney Injury: Acute injury including renal failure can occur. Minimize dose and maintain adequate hydration to minimize risk.
• Cardiovascular Adverse Reactions: Hemodynamic disturbances including shock and cardiac arrest may occur during or after administration.
• Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age: Monitor these patients for thyroid function abnormalities and treat as clinically needed.

Adverse Events: Most common adverse reactions (incidence greater than 0.5%) in adult patients after iodixanol injection: Discomfort, warmth, pain; Cardiovascular: angina. Gastrointestinal: diarrhea, nausea, vomiting. Nervous System: agitation, anxiety, insomnia, nervousness, dizziness, headache, migraine, unusual skin sensations, sensory disturbance, fainting, sensation of spinning. Skin: itchy rash, severe itching, hives. Special Senses: Smell, taste, and vision alteration. Pediatric patients experienced similar adverse reactions.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch or call 1-800-FDA-1088.

• Lactation: A lactating woman may pump and discard breast milk for 10 hours after iodixanol administration.
• Geriatrics: Exercise caution in dose selection for elderly patients.

This Important Safety Information does not include all the information needed to use Iodixanol Injection, USP safely and effectively. Please see full prescribing information, including BOXED WARNING, for Iodixanol Injection, USP at www.fresenius-kabi.com/us.