Seeing is Believing... Look Beneath the Surface
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1 References 1. Idee JM, Port C, Raynal I, et al. Clinical and geological consequences of transmetallation induced by contrast agents for magnetic resonance imaging: a review. Fundamental and Clinical Pharmacology. 200; 20: Prince M., et al. Gadodiamide Administration Causes Spurious Hypocalcemia Radiol. 2003; 227, 3: Tweedle MF, Wedeking P, Kumar K. Biodistribution of Radiolabeled, Formulated Gadopentetate, Gadoteridol, Gadoterate, and Gadodiamide in Mice and Rats. Invest Radiol. 1995; 30; Gibby WA, Gibby KA, Gibby WA. Comparison of Gd DTPA-BMA (Omniscan) versus Gd HP-D03A (ProHance) Retention in Human Bone Tissue by Inductively Coupled Plasma Atomic Emission Spectroscopy. Invest Radiol. 2004; 39: Kirchin M, Runge V, Contrast Agents for Magnetic Resonance Imaging Safety Update. Top Magn Reson Imaging. 2003;14:5. ProHance (gadoteridol) injection mg/ml full Prescribing Information. Princeton, NJ: Bracco Diagnostics Inc.; May Omniscan (gadodiamide) injection, full Prescribing Information. Princeton, NJ: GE HealthCare Inc.; June OptiMARK (gadoversetamide injection) full Prescribing Information. St. Louis, MO: Mallinckrodt Inc.; May Magnevist (brand of gadopentetate dimeglumine) injection full Prescribing Information. Wayne, NJ: Bayer Healthcare Pharmaceuticals Inc.; June MultiHance (gadobenate dimeglumine) injection 529 mg/ml full Prescribing Information. Princeton, NJ: Bracco Diagnostics Inc.; May Emerson J. et al. Spurious Hypocalcemia after Omniscan- or OptiMARK-Enhanced Magnetic Resonance Imaging. Arch Pathol Lab Med. 2004; Vol 128: For more medical information, call Bracco Professional Services: Option 2 For more information about ProHance, visit For more information about Bracco Products, visit or call Bracco Customer Service BRACCO-9 ( ) ProHance is a registered trademark of Bracco Diagnostics Inc. MultiHance is a registered trademark of Bracco Diagnostics Inc. Magnevist is registered trademark of Bayer HealthCare Phamaceuticals Inc. Omniscan is a trademark of GE Healthcare Inc. OptiMARK is a registered trademark of Covidien. BDI Seeing is Believing... Look Beneath the Surface
2 Seeing is Believing... Look Beneath the Surface Of the gadolinium-based contrast agents available for use in the U.S.: ~ ProHance is the first and only macrocyclic and nonionic agent. ~ ProHance has the highest thermodynamic stability constant, conditional stability and lowest osmolality of the nonionic agents1 (Refer to chart on page 4). ~ ProHance is the only nonionic MRI agent that does not interfere with colorimetric serum calcium determinations. 2 acute or chronic severe renal insufficiency (glomerular filtration rate <30mL/min/1.73m2), or
3 Observe the stability of ProHance ProHance, with its macrocyclic molecular structure, has the highest thermodynamic stability constant and conditional stability of the nonionic gadolinium-based MR contrast agents available in the U.S. 1,3,4,5 The Only Nonionic Contrast Agent That Does Not Interfere with Serum Calcium Determinations by Colorimetric Methods 2,11 ProHance (gadoteridol) Omniscan (gadodiamide) 7 OptiMARK (gadoversetamide) 8 Magnevist (gadopentetate dimeglumine) 9 MultiHance (gadobenate dimeglumine) 10 Molecular 5 Gadoteridol Structure Macrocyclic Linear Linear Linear Linear (ProHance ) 4 Gadovesetamide Ionicity Nonionic Nonionic Nonionic Ionic Ionic 3 (OptiMARK ) 4 Osmolality 2 Gadodiamide (mosm/kg, 37ºC) (Omniscan ) 1 Viscosity (cp, OptiMark Omniscan 37ºC) Maximum Adult Dose (mmol/kg) Thermodynamic Stability Constant (ph=1.0) Conditional Stability (ph=7.4) Dissociation half-life (@25 C in 0.1 N HCI) Amount of excess chelate h 35 sec Not Available 10 min Not Available Serum Calcium mg/dl ProHance Magnevist (Gd)mM Chart taken from Prince M., et al. Gadodiamide Administration Causes Spurious Hypocalcemia Radiology 2003; 227, 3: 39-4 *Magnevist is an ionic agent ~ In one clinical study with ProHance and Omniscan, false hypocalcemia was noted in 15.7% of 1049 examinations performed with Omniscan. 2 ~ In the same study, 25 examinations (2.4%), the decreases in serum calcium readings resulted in measurements of critical hypocalcemia, resulting in inappropriate and potentially dangerous calcium therapy in 18 patients. 2 Saline Gadopentate dimegiumine acute or chronic severe renal insufficiency (glomerular filtration rate <30mL/min/1.73m 2 ), or
4 Observe the qualities of ProHance See how ProHance helps you do more ProHance is the only macrocyclic gadolinium-based contrast agent approved for pediatric use in the U.S. Standard Dose ProHance is indicated for use in MRI in children over 2 years of age to visualize lesions with abnormal vascularity in the brain (intracranial lesions), spine and associated tissues. A B C Courtesy of Zoarsky GH, Center for the Health Sciences, UCLA 7 A) T1-weighted precontrast image shows a rounded mass in the jugular foramen region. B) T2-weighted image shows the same mass. C) T1-weighted image after 0.1 mmol/kg ProHance administration shows bright heterogeneous enhancement of the tumor, characteristic of Schwannoma. ProHance is indicated for use in MRI in adults: ~ to visualize lesions with abnormal vascularity in the brain (intracranial lesions), spine and associated tissues. ~ to visualize lesions in the head and neck. acute or chronic severe renal insufficiency (glomerular filtration rate <30mL/min/1.73m2), or
5 ProHance packaging options ProHance is available in 5, 10, 15, 20mL single-dose vials, and 50mL Multipack * (Pharmacy Bulk Packages). Additionally, ProHance is available in prefilled syringes in 10mL and 17mL fill sizes. 8 9 ProHance Ordering Information * Not for Direct Infusion acute or chronic severe renal insufficiency (glomerular filtration rate <30mL/min/1.73m2), or Five 5mL vials Five 10mL vials Five 15mL vials Five 20mL vials Five 10mL prefilled syringes Five 17mL prefilled syringes mL Multipack* * Not for Direct Infusion
6 Why ProHance? ~ High chelate stability reduces interference with calcium testing. 2,11 ~ Indicated for use in CNS MRI for adults and pediatric patients as young as 2 years old. ~ Flexible packaging options ~ The clinical experience of ProHance exceeds 10 million doses safely administered worldwide. 10 acute or chronic severe renal insufficiency (glomerular filtration rate <30mL/min/1.73m 2 ), or acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period. In these patients, avoid the use of gadolinium-based contrast agents unless the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging (MRI). NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle or internal organs. Screen all patients for renal dysfunction by obtaining a history and/or laboratory tests. When administering a gadolinium-based contrast agent, do not exceed the recommended dose and allow a sufficient period of time of elimination of the agent from the body prior to any readministration. As with all paramagnetic agents, caution should be exercised in patients with deoxygenated sickle erythrocytes and renal insufficiency with or without hepatic impairment. The possibility of a reaction, including serious, life threatening, or fatal, anaphylactic or cardiovascular reactions, or other idiosyncratic reactions, should always be considered, especially in those patients with a history of a known clinical hypersensitivity or a history of asthma or other allergic respiratory disorders.
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