Ultravist® (iopromide) injection 240, 300, 370 mg I/mL

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Ultravist® (iopromide) Injection

Ultravist® is a proven X-ray contrast medium with a broad range of FDA-approved indications.

Safety & Clinical Trials

Clinical Indications

As a proven X-ray contrast medium, Ultravist® has a broad range of indications for intravenous and intra-arterial uses:

  • Intra-arterial Procedures1
    • - 300 mgI/mL for cerebral arteriography and peripheral arteriography
    • - 370 mgI/mL for coronary arteriography and left ventriculography, visceral angiography, and aortography
  • Intravenous Procedures1
    • - 240 mgI/mL for peripheral venography
    • - 300 mgI/mL for excretory urography
    • - 300 mgI/mL and 370 mgI/mL for contrast Computed Tomography (CT) of the head and body (intrathoracic, intra-abdominal and retroperitoneal regions) for the evaluation of neoplastic and non-neoplastic lesions
    • - The usefulness of contrast enhancement for the investigation of the retrobulbar space of low grade or infiltrative glioma has not been demonstrated

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

ULTRAVIST® INJECTION-A BALANCED CONTRAST MEDIUM

Ultravist® Injection has amassed clinical experience in over 150 million patients.* Developed by Bayer Healthcare LLC, Ultravist® Injection was launched in Europe in 1985, and is now in its 25th year as a global brand. In 1995, it was approved for use in radiographic procedures by the FDA and introduced in the United States. Ultravist® Injection is supported by Bayer HealthCare LLC, a world leader in diagnostics serving the radiology community and specialists worldwide.

Ultravist® Injection has been proven in a number of large-scale studies. US clinical trials included 1,142 patients. Overall, 24% of patients receiving Ultravist® during clinical trials experienced one or more adverse reactions (ARs).¹

MOST FREQUENT ARs IN IOPROMIDE GROUP¹

The possibility of serious life-threatening reactions should always be considered when administering Ultravist®.

  • In clinical trials, 7 out of 1142 patients died 5 days or later following administration of Ultravist®. Also, 10 patients experienced serious adverse events.

Reference: 1. Ultravist Injection [package insert]. Berlin, Germany: Bayer HealthCare Pharmaceuticals; 2012.

*BSP internal reporting systems (liters sold) assuming an average dose of 100 mL/procedure (as measured in AMR).

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Dosing

Dosing

  • Visually inspect Ultravist® for particulate matter and/or discoloration, whenever solution and container permit. Do not administer Ultravist® if particulate matter and/or discoloration is observed.
  • Determine the volume and concentration of Ultravist® Injection to be used, taking into account factors such as age, body weight, size of the vessel, and the rate of blood flow within the vessel; consider also extent of opacification required, structure(s) or area to be examined, disease processes affecting the patient, and equipment and technique to be employed. Specific dose adjustments for age, gender, weight and renal function have not been studied for Ultravist® Injection. As with all iodinated contrast agents, lower doses may have less risk. The efficacy of Ultravist® Injection below doses recommended has not been established.
  • The maximum recommended total dose of iodine in adults is 86 grams; a maximum recommended total dose of iodine has not been established for pediatric patients.
  • Hydrate patients adequately prior to and following the administration of Ultravist® [see Warnings and Precautions in the Full Prescribing Information]
  • Warming Ultravist® to body temperature shortly before administration may help improve tolerability and ease of injection

Intra-Arterial Procedures

The volume and rate of injection of the contrast agent will vary depending on the injection site and the area being examined. Inject contrast at rates approximately equal to the flow rate in the vessel being injected.

  • Cerebral Arteriography (300 mgI/mL), Coronary Arteriography and Left Ventriculography (370 mgI/mL), Peripheral Arteriography (300 mgI/mL): see Table 1.
  • Aortography and Visceral Angiography (370 mgI/mL): Use a volume and rate of contrast injection proportional to the blood flow and related to the vascular and pathological characteristics of the specific vessels being studied. Do not exceed 225 mL as total dose for the procedure.
Table 1: SUGGESTED SINGLE INJECTION DOSES FOR ADULT INTRO-ARTERIAL PROCEDURES¹

Intravenous Procedures

  • Peripheral Venography (240 mgI/mL): Inject the minimum volume necessary to visualize satisfactorily the structures under examination. Do not exceed 250 mL as total dose for the procedure.
  • Contrast Computed Tomography (CT) (300 mgI/mL and 370 mgI/mL) and Excretory Urography (300 mgI/mL): see Table 2.
Table 2: SUGGESTED ULTRAVIST INJECTION DOSING FOR ADULT INTRAVENOUS CONTRAST ADMINISTRATION

Pediatric Dosing

The recommended dose in children over 2 years of age for the following evaluations is:

  • Intra-arterial: Cardiac chambers and related arteries (370 mgI/mL): Inject 1 to 2 milliliters per kilogram (mL/kg). Do not exceed 4 mL/kg as total dose.
  • Intravenous: Contrast Computerized Tomography or Excretory Urography (300 mgI/mL): Inject 1 to 2 mL/kg. Do not exceed 3 mL/kg as total dose.

The safety and efficacy relationships of other doses, concentrations or procedures have not been established [see Use in Specific Populations (8.4) and Clinical Pharmacology (12.3) in the Full Prescribing Information].

Dosage Forms and Strengths

Ultravist® Injection is a nonionic, sterile, clear, colorless to slightly yellow, odorless, pyrogen-free aqueous solution of iopromide, containing 2.42 mg/mL tromethamine buffer and 0.1 mg/mL edetate calcium disodium stabilizer. Ultravist Injection is available in three strengths:

  • 240 mg I/mL provides 498.72 mg/mL iopromide
  • 300 mg I/mL provides 623.4 mg/mL iopromide
  • 370 mg I/mL provides 768.86 mg/mL iopromide

Reference: 1.Ultravist Injection [package insert]. Berlin, Germany: Bayer HealthCare Pharmaceuticals; 2012.

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Formulation and Packaging

Formulation and Packaging

Ultravist® Injection is available as a stable, ready-to-use aqueous solution of iopromide in vials or bottles in concentrations of 240 mg, 300 mg, and 370 mg iodine per mL. Ultravist® is available in a number of vial sizes including the 500 mL Pharmacy Bulk Package.

Packaging

  • Color-coded vials for easy identification of concentration
  • Integrated hanger labels
  • Clear glass vials/bottles for examination of product clarity
  • Peel-off product identification labels
  • Pharmacy bulk package offers industry-leading 10-hour stand time, allowing flexibility to use doses as needed
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Reimbursement

Reimbursement Support

If you have a question about reimbursement, please contact the Reimbursement Support Hotline:

  • Telephone: 1-800-423-7539
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Purchasing

Purchasing Resources

In today's cost-conscious healthcare environment, Bayer HealthCare LLC offers a comprehensive line of quality imaging products at competitive prices combined with highly regarded service and support. Knowing that purchasers have unique requirements, we do our best to provide creative yet competitive contracts that go beyond just meeting product needs. Additional purchasing resources are described below.

Bayer HealthCare LLC's partnership with McKesson Specialty Care Solutions combines Bayer's commitment to our customers with the drug distribution of McKesson, focused on delivering the right product to the right place at the right time. McKesson's reputation for reliable service makes them an ideal solution through which to source your Bayer HealthCare LLC imaging products.

Suppliers are listed below in alphabetical order.

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INDICATIONS and IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE

Ultravist® (iopromide) Injection is an iodinated contrast agent indicated for:

Intra-arterial Procedures*: 300 mg I/mL for cerebral arteriography and peripheral arteriography; 370 mg I/mL for coronary arteriography and left ventriculography, visceral angiography, and aortography.

Intravenous Procedures*: 240 mg I/mL for peripheral venography; 300 mg I/mL for excretory urography; 300 mg I/mL and 370 mg I/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

WARNING: NOT FOR INTRATHECAL USE

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 (e.g. prolonged fasting and the administration of a laxative before Ultravist® Injection) is contraindicated in pediatric patients because of risk of renal failure.

SELECTED WARNINGS AND PRECAUTIONS:

  • Life-threatening or fatal anaphylactoid reactions may occur during or after Ultravist® administration, particularly in patients with allergic disorders.
  • 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. Adequately hydrate patients prior to and following Ultravist® administration.
  • Hemodynamic disturbances including shock and cardiac arrest may occur during or shortly after administration of Ultravist®.
  • 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.
  • Extravasation of Ultravist® may cause tissue necrosis and/or compartment syndrome, particularly in patients with severe arterial or venous 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.

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.

Please see Full Prescribing Information.

You are encouraged to report negative side effects or quality complaints of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.