Iodixanol

VISIPAQUE is indicated for: VISIPAQUE 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 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 and 320 mg Iodine/mL). Excretory urography (270 and 320 mg Iodine/mL). Peripheral venography (270 mg Iodine/mL).

Intravascular injection of iodixanol opacifies vessels in the path of flow of the contrast agent, permitting visualization of internal structures. In imaging of the body, iodinated contrast agents diffuse from the vascular into the extravascular space. In a normal brain with an intact blood-brain barrier, contrast does not diffuse into the extravascular space. In patients with a disrupted blood-brain barrier, contrast agent accumulates in the interstitial space in the region of disruption.

Individualize the combination of volume and concentration of VISIPAQUE Injection considering age, body weight, size of the vessel, rate of blood flow within the vessel, and other applicable factors. For CT of the head and body, VISIPAQUE may be used with an automated contrast injection system or contrast media management system cleared for use with VISIPAQUE. For the adult patients, the maximum recommended total dose of iodine is 80 grams. Patients should be adequately hydrated prior to and following the intravascular administration of iodinated contrast agents. See full prescribing information for complete dosing and administration information.

VISIPAQUE is contraindicated for intrathecal use. Not indicated for intrathecal use.

Boxed warning (not for intrathecal use): Inadvertent intrathecal administration may cause death, convulsions/seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema. 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: Individualize thyroid function monitoring based on risk factors such as prematurity.

The following clinically significant adverse reactions are described elsewhere in the labeling: Risks Associated with Inadvertent Intrathecal Administration Hypersensitivity Reactions Contrast-Induced Kidney Injury Cardiovascular Adverse Reactions Thromboembolic Events Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age Severe Cutaneous Adverse Reactions Most common adverse reactions (incidence greater than 0.5%) in adult patients after VISIPAQUE 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.

Drug-Drug Interactions Metformin In patients with renal impairment, metformin can cause lactic acidosis. Iodinated contrast agents appear to increase the risk of metformin-induced lactic acidosis, possibly as a result of worsening renal function. Stop metformin at the time of, or prior to, VISIPAQUE administration in patients with an eGFR between 30 and 60 mL/min/1.73 m 2, in patients with a history of hepatic impairment, alcoholism or heart failure, or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure, and reinstitute metformin only after renal function is stable. Radioactive Iodine Administration of iodinated contrast agents may interfere with thyroid uptake of radioactive iodine (I-131 and I-123) and decrease therapeutic and diagnostic efficacy in patients with carcinoma of the thyroid.

Store VISIPAQUE at controlled room temperature, 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). VISIPAQUE may be stored in a contrast media warmer for up to one month at 37°C (98.6°F). Do not freeze. Discard any product that is inadvertently frozen, as freezing may compromise the closure integrity of the immediate container.