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PROHANCE Benefits

By all measures, ProHance is an exceptionally stable Gd chelate1-4

  • The amount of Gd3+ released depends on the thermodynamic, conditional and kinetic stabilities of the Gd chelate4

  • ProHance has the highest thermodynamic constant and conditional stability, and lowest osmolality, of the CNS MRI nonionic agents1-4

  • High kinetic stability—an important factor in gadolinium-chelate safety.4 Linear agents have the potential to dissociate from
    the chelate in the presence of competing ions like Zn2+ and Cu2+, while ProHance effectively resists transmetallation1

  • High kinetic stability combined with high conditional stability appears to minimize the amount of free Gd released in the body4

  • ProHance is formulated with very little excess chelate relative to other less-stable approved agents3

    PH_Benefits chart.jpg
  • Low retention of Gd in bone—two to four times less residual Gd found in bone after ProHance administration vs. Omniscan in clinical studies12,13

  • In renally imparied patients, conditional stability and kinetic stability are equally important, as GBCAs may go into deep storage in bone and reach pseudo-equilibrium4

See how ProHance helps you do more

ProHance is indicated for use in MRI in adults to visualize lesions with abnormal vascularity in the brain, spine, head,
neck and associated tissues.5

It’s also indicated for use in children over two years of age to visualize lesions with abnormal vascularity in the brain, spine and associated tissues.5

ProHance has the highest thermodynamic stability constant of all nonionic gadolinium-based MR contrast agents
available in the U.S.1-4

In clinical studies, ProHance provided additional diagnostic information in 45% to 48% of scans5, where 8% to 25% of
the diagnoses were changed as a result.5

PH_Benefits_MJMchart.jpg

These are representative images courtesy of Zoarsky GH, Center for the Health Sciences, UCLA. Individual results may vary.

REFERENCES: 1. Tweedle MF, Hagan JJ, Kumar K, Mantha S, Chang CA. Reaction of gadolinium chelates with endogenously available ions. Magn Reson Imaging. 1991;9:409-415. 2. Van der Molen AJ. Nephrogenic Systemic Fibrosis and the Role of Gadolinium Contrast Media. J Med Imaging Rad Oncol. 2008:52:339-350. 3. Kirchin MA, Runge VM. Contrast agents for magnetic resonance imaging: safety update. Top Magn Reson Imaging. 2003;14:426-435. 4. Idée JM, Port M, Robic C, Medina C, Sabatou M, Corot C. Role of thermodynamic and kinetic parameters in gadolinium chelate stability. J Magn Reson Imaging.2009;30:1249-1258. 5. ProHance (gadoteridol) injection 279.3 mg/mL full Prescribing Information. Princeton, NJ: Bracco Diagnostics Inc.; July 2011.. 6. Omniscan(gadodiamide) injection full Prescribing Information. Princeton, NJ: GE HealthCare Inc.; June 2007. 7. OptiMARK (gadoversetamide injection) full PrescribingInformation. St. Louis, MO; Mallinckrodt Inc.; May 2007. 8. Magnevist (brand of gadopentetate dimeglumine) injection full Prescribing Information. Wayne, NJ; BayerHealthcare Pharmaceuticals Inc.; June 2007. 9. MultiHance (gadobenate dimeglumine) injection, 529 mg/mL full Prescribing Information. Princeton, NJ: Bracco Diagnostics Inc. July 2011. 10. Van der Molen AJ. Nephrogenic Systemic Fibrosis and the Role of Gadolinium Contrast Media. J Med Imaging Rad Oncol.2008;52:339-350. 11. Van der Molen AJ, et al. Extracellular gadoliniumbased contrast media: Differences in diagnostic efficacy. EJR. 2008;66:168-174. 12. White GW, Gibby WA, Tweedle MF. Comparison of Gd (DTPA-BMA) (Omniscan) versus Gd (HP-Do3A) (ProHance) relative to gadolinium retention in human bone tissueby inductively coupled plasma mass spectroscopy. Invest Radiol. 2006;41:272-278. 13. 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;39:138-142.

 

 

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PROHANCE INDICATIONS AND USAGE
Central Nervous System
ProHance (Gadoteridol) Injection is indicated for use in MRI in adults and children over 2 years of age to visualize lesions with abnormal vascularity in the brain (intracranial lesions), spine and associated tissues.

Extracranial/Extraspinal Tissues
ProHance is indicated for use in MRI in adults to visualize lesions in the head and neck.

IMPORTANT SAFETY INFORMATION

WARNING: NEPHROGENIC SYSTEMIC FIBROSIS
Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle and internal organs.

  • The risk for NSF appears highest among patients with:
    • chronic, severe kidney disease (GFR <30 mL/min/1.73m2), or
    • acute kidney injury.
  • Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g. age > 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.
  • For patients at highest risk for NSF, do not exceed the recommended ProHance dose and allow a sufficient period of time for elimination of the drug from the body prior to re-administration [See Warnings ]

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 disorders.

Please consult full Prescribing Information for ProHance including boxed WARNING contained within this website.

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

All trademarks and registered trademarks are the property of their respective owners.

MultiHance is manufactured for Bracco Diagnostics Inc. by BIPSO GmbH – 78224 Singen (Germany) and by Patheon Italia SpA, Ferentino, Italy.
ProHance is manufactured for Bracco Diagnostics Inc. by BIPSO GmbH – 78224 Singen (Germany).