Inadvertent intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema.

Anaphylactoid Reactions: Life‐threatening or fatal anaphylactoid reactions may occur during or after Ultravist^® administration, particularly in patients with allergic disorders. Increased risk is associated with a history of previous reaction to a contrast agent, a known sensitivity to iodine and known allergic disorders or other hypersensitivities. Exercise extreme caution when considering the use of iodinated contrast agents in patients with these histories or disorders. Emergency facilities and personnel trained in the treatment of anaphylactoid reactions should be available for at least 30 to 60 minutes after Ultravist^® administration.

Contrast Induced Acute Kidney Injury: Acute kidney injury, including renal failure, may occur after intravascular administration of Ultravist®. Risk factors include: pre‐existing renal insufficiency, dehydration, diabetes mellitus, congestive heart failure, advanced vascular disease, elderly age, concomitant use of nephrotoxic or diuretic medications, multiple myeloma/paraproteinemia, repetitive and/or large doses of Ultravist®. Use the lowest necessary dose of Ultravist^® in patients with renal impairment. Hydrate patients, as appropriate, prior to and following Ultravist^® administration.

Cardiovascular Reactions: Hemodynamic disturbances including shock and cardiac arrest may occur during or shortly after administration of Ultravist^®. Observe patients with preexisting cardiovascular disease for several hours following Ultravist^® administration.

Thromboembolic Complications: Angiography may be associated with local and distal organ damage, ischemia, thromboembolism and organ failure. In angiographic procedures, consider the possibility of dislodging plaques or damaging or perforating the vessel wall. The physicochemical properties of the contrast agent, the dose and the speed of injection can influence the reactions. Monitor electrocardiograms and vital signs throughout the procedure. Exercise care when performing venography in patients with suspected thrombosis, phlebitis, severe ischemic disease, local infection, venous thrombosis or a totally obstructed venous system. Clotting may occur when blood remains in contact with syringes containing iodinated contrast agents. Avoid angiography whenever possible in patients with homocystinuria because of the risk of inducing thrombosis and embolism.

Reactions in Patients with Hyperthyroidism, Pheochromocytoma, or Sickle Cell Disease:

Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age: Thyroid dysfunction has been reported after both single and multiple exposure(s) to iodinated contrast media. Among patients 0 to 3 years of age, thyroid dysfunction has been reported in 1% to 15% depending on age of the patient and dose of the agent. Younger age, very low birth weight, prematurity, and other conditions, (admission to neonatal or pediatric intensive care units, and cardiac conditions) are associated with an increased risk. Pediatric patients with cardiac conditions may be at the greatest risk as they often require high doses of contrast during invasive cardiac procedures.

Pediatric patients 0 to 3 years of age warrant closer monitoring because an underactive thyroid during early life may be harmful for motor, hearing, and cognitive development and may require transient T4 replacement therapy. Evaluate thyroid function in all pediatric patients 0 to 3 years of age within 3 weeks following exposure to iodinated contrast media, especially in term and preterm neonates. If thyroid dysfunction is detected, treat and monitor thyroid function as clinically needed.

The safety and effectiveness of Ultravist^® in pediatric patients younger than 2 years of age have not been established, and Ultravist^® is not approved for use in pediatric patients younger than 2 years of age.

Extravasation: Extravasation of Ultravist^® may cause tissue necrosis and/or compartment syndrome, particularly in patients with severe arterial or venous disease.

Increased Radiation Exposure: The decision to use contrast enhancement is associated with risk and increased radiation exposure.

Interference with Image Interpretation: The use of Ultravist^® injection may obscure some lesions which were seen on non-contrast CT scans. Calcified lesions are less likely to enhance. The enhancement of tumors after therapy may decrease. The opacification of the inferior vermis following contrast agent administration has resulted in false-positive diagnosis. Cerebral infarctions of recent onset may be better visualized with contrast enhancement. However, older infarctions may be obscured by the contrast agent. In patients with normal blood-brain barriers and renal failure, iodinated contrast agents have been associated with blood-brain barrier disruption and accumulation of contrast in the brain. Accumulation of contrast in the brain also occurs in patients where the blood-brain barrier is known or suspected to be disrupted.

Severe Cutaneous Adverse Reactions: Severe cutaneous adverse reactions (SCAR) may develop from 1 hour to several weeks after intravascular contrast agent administration. These reactions include Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN), acute generalized exanthematous pustulosis (AGEP) and drug reaction with eosinophilia and systemic symptoms (DRESS). Reaction severity may increase and time to onset may decrease with repeat administration of contrast agent; prophylactic medications may not prevent or mitigate severe cutaneous adverse reactions. Avoid administering Ultravist^® to patients with a history of a severe cutaneous adverse reaction to Ultravist^® .

Most Common Adverse Reactions: Most common adverse reactions (>1%) are headache, nausea, injection site and infusion site reactions, vasodilatation, vomiting, back pain, urinary urgency, chest pain, pain, dysgeusia, and abnormal vision.

Indications and Usage

Please see Full Prescribing Information for Ultravist^® (Vials).