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Experts agree that levels of Gd retention can vary among macrocyclic agents.3-7 Peer reviewed studies demonstrate that at up to 5 weeks ProHance (Gadoteridol)® has the lowest Gd retention in the brain in four animal studies.*,3,4,7,8

*Generalizability of animal model results to humans has not been established 6

Although the American College of Radiology (ACR) and the Food and Drug Administration (FDA) agree that there are no known adverse clinical consequences associated with Gd retention in the brain based on the available data,9,10 some practitioners may have concerns in light of the litigation environment surrounding GBCAs.

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In this paper, the Barrow Neurological Institute shares

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References
Important Safety Information

ProHance® (Gadoteridol) Injection, 279.3 mg/mL
and ProHance® Multipack (Gadoteridol) Injection, 279.3 mg/mL

Indications and Usage:
CENTRAL NERVOUS SYSTEM

ProHance® (Gadoteridol) Injection, 279.3 mg/mL is indicated for use in MRI in adults and pediatric patients including term neonates to visualize lesions with disrupted blood brain barrier and/or abnormal vascularity in the brain (intracranial lesions), spine and associated tissues.

EXTRACRANIAL/EXTRASPINAL TISSUES

ProHance® (Gadoteridol) Injection, 279.3 mg/mL 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).

CONTRAINDICATIONS
Contraindicated in patients with known allergic or hypersensitivity reactions to ProHance

WARNINGS AND PRECAUTIONS
Nephrogenic Systemic Fibrosis: NSF has occurred in patients with impaired elimination of GBCAs. Higher than recommended dosing or repeated dosing appears to increase risk.
Hypersensitivity Reactions: Anaphylactic and anaphylactoid reactions have been reported, involving cardiovascular, respiratory, and/or cutaneous manifestations. Some patients experienced circulatory collapse and died. In most cases, initial symptoms occurred within minutes of administration and resolved with prompt emergency treatment. Prior to ProHance administration, ensure the availability of trained personnel and medications to treat hypersensitivity reactions. Consider these risks, especially in patients with a history of hypersensitivity reactions or a history of asthma or other allergic disorders.
Gadolinium Retention: Gadolinium is retained for months or years in several organs. The highest concentrations have been identified in the bone, followed by brain, skin, kidney, liver, and spleen. Linear GBCAs cause more retention than macrocyclic GBCAs. Consequences of gadolinium retention in the brain have not been established, but they have been established in the skin and other organs in patients with impaired renal function.
Acute Kidney Injury: In patients with chronically reduced renal function, acute kidney injury requiring dialysis has occurred with the use of GBCAs. The risk of acute kidney injury may increase with increasing dose of the contrast agent; administer the lowest dose necessary for adequate imaging.

ADVERSE REACTIONS
The most commonly reported adverse reactions are nausea and taste perversion with an incidence = 0.9%.

USE IN SPECIFIC POPULATIONS
Pregnancy: GBCAs cross the human placenta and result in fetal exposure and gadolinium retention. Use only if imaging is essential during pregnancy and cannot be delayed.
Lactation: There are no data on the presence in human milk, the effects on the breastfed infant, or the effects on milk production. However, published lactation data on other GBCAs indicate that 0.01 to 0.04% of the maternal gadolinium dose is present in breast milk.
Pediatric Use: The safety and effectiveness of ProHance have been established for use with MRI to visualize lesions with abnormal blood brain barrier or abnormal vascularity of the brain, spine, and associated tissues in pediatric patients from birth, including term neonates, to 17 years of age. Adverse reactions in pediatric patients were similar to those reported in adults. No case of NSF associated with ProHance or any other GBCA has been identified in pediatric patients ages 6 years and younger.

Please see full Prescribing Information and Patient Medication Guide for additional important safety information for/regarding ProHance® (Gadoteridol) Injection, 279.3 mg/mL at https://imaging.bracco.com/us-en/products/magnetic-resonance-imaging/prohance

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

ProHance is manufactured for Bracco Diagnostics Inc. by BIPSO GmbH – 78224 Singen (Germany).

ProHance is a registered trademark of Bracco Diagnostics Inc.

ProHance Multipack is a trademark of Bracco Diagnostics Inc.

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

Bracco Diagnostics Inc.
259 Prospect Plains Road, Building H
Monroe Township, NJ 08831 USA
Phone: 609-514-2200
Toll Free: 1-877-272-2269 (U.S. only)
Fax: 609-514-2446

©2021 Bracco Diagnostics Inc. All Rights Reserved.

References:

  1. ProHance® (gadoteridol) injection full Prescribing Information and Patient Medication Guide. Monroe Twp., NJ: Bracco Diagnostics Inc.; December 2020.
  2. Data on file. Bracco Diagnostics Inc. based on IQVIA DDD: January 2020.
  3. Bussi S, Coppo A, Botteron C, et al. Differences in gadolinium retention after repeated injections of macrocyclic MR contrast agents to rats. J Magn Reson Imaging. 2018;47(3):746-752. (Macrocyclic MR contrast agents administered to rats over a 5 week period and Gd retention tested 4 weeks after last administration).
  4. McDonald RJ, McDonald JS, Dai D, et al. Comparison of gadolinium concentrations within multiple rat organs after intravenous administration of linear versus macrocyclic gadolinium chelates. Radiology. 2017; 285(2):536-545. (Linear and macrocyclic MR contrast agents administered to rats over a 26 day period and Gd retention tested 7 days after final administration).
  5. Guo BJ, Yang ZL, Zhang LJ. Gadolinium deposition in brain: current scientific evidence and future perspectives. Front Mol Neurosci. 2018;11:335. (Review article).
  6. McDonald RJ, Levine D, Weinreb J, et al. Gadolinium retention: a research roadmap from the 2018 NIH/ACR/RSNA workshop on gadolinium chelates. Radiology. 2018;289(2):517-534.
  7. Bussi S, Coppo A, Celeste R, et al. Macrocyclic MR contrast agents: evaluation of multiple-organ gadolinium retention in healthy rats. Insights Imaging. 2020;11(11):doi.org/10.1186/s13244-019-0824-5.
  8. Jost G, Frenzel T, Boyken J, Lohrke J, Nischwitz V, Pietsch H. Long-term excretion of gadolinium-based contrast agents: linear versus macrocyclic agents in an experimental rat model. Radiology. 2018;13:180135. (Linear and macrocyclic MR contrast agents administered to rats over a 2 week period and Gd retention tested 5, 26 and 52 weeks after administration).
  9. FDA Drug Safety Communication: New warnings for using gadolinium-based contrast agents in patients with kidney dysfunction. FDA website. https://www.fda.gov/Drugs/DrugSafety/ucm223966.htm. Accessed December 19, 2018.
  10. ACR Committee on Drugs and Contrast Media. ACR Manual on Contrast Media. Version 10.3.2018. Accessed January 2019.
  11. Murata N, Gonzalez-Cuyar LF, Murata K, et al. Macrocyclic and other non-group 1 gadolinium contrast agents deposit low levels of gadolinium in brain and bone tissue: preliminary results from 9 patients with normal renal function. Invest Radiol. 2016;51(7):447-453. (Tissue samples were collected from 9 decedents undergoing autopsy who had contrast-enhanced magnetic resonance imaging (MRI) with only single agent exposure to a non-Group 1 Gd-based contrast agent).
  12. Aime, S. Letters to the Editor Differences in Molecular Structure Markedly Affect GBCA Elimination Behavior. Radiology 2019; Published Online: Feb 26 2019 https://doi.org/10.1148/radiol.2019182748.