INDICATIONS and IMPORTANT SAFETY INFORMATION
INDICATIONS AND USAGE
Ultravist® (iopromide) injection is an iodinated contrast agent indicated for:
Intra‐arterial Procedures*: 300 mg Iodine per mL for cerebral arteriography and peripheral arteriography; 370 mg Iodine per mL for coronary arteriography and left ventriculography, visceral angiography, and aortography.
Intravenous Procedures*: 240 mg Iodine per mL for peripheral venography; 300 mg Iodine per mL for excretory urography; 300 mg Iodine per mL and 370 mg Iodine per mL for contrast Computed Tomography (CT) of the head and body (intrathoracic, intraabdominal and retroperitoneal regions) for the evaluation of neoplastic and non‐neoplastic lesions. The usefulness of contrast enhancement for the investigation of the retrobulbar space and of low grade or infiltrative glioma has not been demonstrated.
*For information on the concentrations and doses for the Pediatric Population [see Dosage and Administration (2.3) and Use in Specific Populations (8.4) in the Full Prescribing Information].
IMPORTANT SAFETY INFORMATION
Inadvertent intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema.
Contraindications: Ultravist® injection is contraindicated for intrathecal use.
Preparatory dehydration (for example, prolonged fasting and the administration of a laxative before Ultravist® injection) is contraindicated in pediatric patients because of risk of renal failure.
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 homocysteinuria because of the risk of inducing thrombosis and embolism.
Reactions in Patients with Hyperthyroidism, Pheochromocytoma, or Sickle Cell Disease: Thyroid storm has occurred after the intravascular use of iodinated contrast agents in patients with hyperthyroidism, or with autonomously functioning thyroid nodule. Evaluate the risk in such patients before use of any iodinated contrast agent. Administer iodinated contrast agents with extreme caution in patients with known or suspected pheochromocytoma. Inject the minimal amount of contrast necessary. Contrast agents may promote sickling in individuals who are homozygous for sickle cell disease when administered intravascularly.
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.