Ioversol

OPTIRAY is indicated for: OPTIRAY is a radiographic contrast agent indicated for the following: Intra-arterial Procedures. Adults: Cerebral Arteriography (300, 320 mg iodine/mL) Peripheral Arteriography (300, 320, 350 mg iodine/mL ) Visceral and Renal Arteriography, Aortography (320 mg iodine/mL) Coronary Arteriography and Left Ventriculography (320, 350 mg iodine/mL) Pediatric Patients: Angiocardiography (320, 350 mg iodine/mL) Intravenous Procedures. Adults: Computed tomography (CT) Imaging of Head and Body (300, 320, 350 mg iodine/mL) Venography (300, 320, 350 mg iodine/mL) Intravenous Excretory Urography (300, 320, 350 mg iodine/mL) Intravenous Digital Subtraction Angiography (350 mg iodine/mL) Pediatric Patients: CT Imaging of the Head and Body, and Intravenous Excretory Urography (320 mg iodine/mL)

Intravascular injection of ioversol opacifies vessels in the path of the flow of the contrast medium, permitting visualization of the internal structures until significant hemodilution occurs. In imaging of the body, iodinated contrast agents diffuse from the vascular into the extravascular space. In 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.

Adjust the volume and concentration of OPTIRAY. Modify the dose accounting for factors such as age, body weight, vessel size, blood flow rate within the vessel. Please see details in full Prescribing Information.

Symptomatic Hyperthyroidism Symptomatic Hyperthyroidism

Boxed warning (risks with inadvertent intrathecal administration for intra-arterial and intravenous use only): Inadvertent intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, 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.

The following clinically significant adverse reactions are described elsewhere in the labeling: Risks Associated with Inadvertent Intrathecal Administration Hypersensitivity Reactions Contrast Induced Acute Kidney Injury Cardiovascular Adverse Reactions Thromboembolic Events Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age Severe Cutaneous Adverse Reactions The most common reaction is nausea, occurring at a rate of 1 percent.

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, OPTIRAY 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 agents. Re-evaluate eGFR 48 hours after the imaging procedure, and reinstitute only after renal function is stable. Radioactive Iodine Administration of iodinated contrast agents may interfere with thyroid uptake of radioactive iodine (I 131) and decrease therapeutic efficacy in patients with carcinoma of the thyroid. The decrease in efficacy lasts for 6-8 weeks.

Storage Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F). Store up to 40°C (104°F) for up to one month in a contrast media warmer utilizing circulating warm air. Protect from strong daylight or direct exposure to the sun. May store OPTIRAY for periods longer than one month. Store OPTIRAY RFID-tagged syringes at the same conditions listed for the drug product.