Ultravist Prescribing Information
WARNING: NOT FOR INTRATHECAL USE
Intrathecal administration, even if inadvertent, may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. ULTRAVIST is not approved for intrathecal use. (5.1)
Indications and Usage (
ULTRAVIST is indicated for:
• Excretory urography in adults and pediatric patients aged 2 years and older• Contrast Computed Tomography (CT) of the head and body (intrathoracic, intra-abdominal, and retroperitoneal regions) for the evaluation of neoplastic and non-neoplastic lesions in adults and pediatric patients aged 2 years and older• Contrast mammography to visualize known or suspected lesions of the breast in adults, as an adjunct following mammography and/or ultrasound
†Specific concentrations and presentations of ULTRAVIST are recommended for each type of imaging procedure
Dosage and Administration 5/2023
Warning and Precautions (
Extravasation can occur with ULTRAVIST, particularly in patients with severe arterial or venous disease. Inflammation, blistering, skin necrosis, and compartment syndrome have been reported following extravasation. In addition, injection site reactions such as pain and swelling at the injection site can also occur
ULTRAVIST® Injection is an iodinated contrast agent indicated for:
• Individualize the volume and concentration according to the specific dosing tables accounting for factors such as age, body weight, size of the vessel, and the rate of blood flow within the vessel.• For contrast mammography, use ULTRAVIST with a device that is cleared for dual-energy full field digital mammography.• See full prescribing information for important dosage and administration instructions and directions for use of pharmacy bulk packages and imaging bulk packages.
ULTRAVIST injection is a clear, colorless to slightly yellow, odorless solution available in two concentrations:
• 50 mL, 100 mL, 125 mL, and 150 mL in single-dose vials• 200 mL and 500 mL in pharmacy bulk packages• 200 mL and 500 mL in imaging bulk packages
• 50 mL, 100 mL, 125 mL, and 150 mL in single-dose vials• 200 mL and 500 mL in pharmacy bulk packages• 200 mL and 500 mL in imaging bulk packages
There are no data on ULTRAVIST use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Iopromide crosses the placenta and reaches fetal tissues in small amounts
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.