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

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Ultravist® (iopromide) injection

Ultravist®, an integral part of our CT portfolio, is a proven X-ray contrast medium with a broad range of FDA-approved indications.

A COMBINATION OF EXPERIENCE AND VERSATILITY FOR TODAY'S RADIOLOGY PRACTICE

  • Safety
  • Efficacy
  • Experience
  • Versatility
  • Studied in clinical trials
  • Visualization rated good to excellent in 97% - 99% of Phase III Clinical Trial patients¹
    • Assessment was based on evaluation of radiograph quality by rating visualization as excellent, good, poor, or no image for five intra-arterial and three intravenous procedures among 708 patients¹
    • Used in more than 120 countries worldwide*
    • Over 13 million vials sold in 2015
  • With a wide range of concentrations and packaging to support today's imaging applications¹

*Based on YTD January-August 2016 Bayer Internal Sales Data.²

Based on 2015 Bayer Internal Sales Data.²

Reference: 1. Ultravist Injection [package insert]. Berlin, Germany: Bayer HealthCare Pharmaceuticals. 2. Data on File, 2016. Bayer HealthCare

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 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 Procedures¹
    • - 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, 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.

Developed by Bayer Healthcare LLC, Ultravist® Injection was launched in Europe in 1985, and is now in its 30th year as a global brand. Ultravist® Injection is supported by Bayer HealthCare LLC, a world leader in diagnostics serving the radiology community and specialists worldwide.

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

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Dosing

Intra-Arterial Procedures

Intravenous Procedures

Pediatric Dosing

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 mg Iodine per mL), Coronary Arteriography and Left Ventriculography (370 mg Iodine per mL), Peripheral Arteriography (300 mg Iodine per mL): see Table 1.
  • Aortography and Visceral Angiography (370 mg Iodine per 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.

For additional information, click the Intravenous Procedures and Pediatric Dosing tabs above.

Dosage Forms and Strengths

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

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

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

Reference: 1.Ultravist Injection [package insert]. Berlin, Germany: Bayer HealthCare Pharmaceuticals; 2015.

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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 Iodine per mL, 300 mg Iodine per mL, and 370 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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Commitment

Committed to access and quality and expanding the tools that support clinical imaging

Uninterrupted access and high-quality supply are more important than ever. From our history of first-to-market products to our ongoing research, Bayer continuously invests in new technology to help meet the needs of the imaging community.

The synthesis and formulation of Ultravist® require expert knowledge and advanced technology.

Bayer invests in production sites to support availability and adherence to quality standards at every step, including:

  • Established additional Ultravist® production line in Bergkamen, Germany to address increasing worldwide demand and maintain consistent supply
  • Compliance with Good Manufacturing Practices (GMP)¹

Click here to view a video highlighting Bayer's contrast manufacturing facility.

From our history of first-to-market products to our on-going research, Bayer continuously invests in new technology to help meet the needs of the imaging community:

  • Developed the first MR power injector in the U.S.
  • Developed the first CT power injector in the U.S.
  • Pioneered development in Radiation Dose and Contrast Dose Management informatics with consistent software upgrades every year
  • Developed the first PET FDG infusion system in the U.S.

Reference: 1. Data on File, 2016. Bayer HealthCare

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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 (1-877-259-4624) 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.

Additional independent 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 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

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.

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

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.

Please see Full Prescribing Information.

PP-346-US-0062 April 2017

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