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The first macrocyclic gadolinium MRI contrast agent approved in the U.S. for CNS MRI

ProHance® (gadoteridol) injection, 279.3 mg/mL is the first macrocyclic, nonionic MRI contrast agent approved for use in the U.S. for CNS MRI. ProHance has the lowest osmolality of all contrast agents in its class.1

Since its launch in 1992, ProHance has been administered more than 14.5 million times worldwide.2 It’s the only nonionic contrast agent for CNS MRI with a supplementary dose indication in adults (0.1 plus 0.2 mmol/kg cumulative dose).3,4

Learn More about the TRUTH Study1
Link to abstract: http://www.ncbi.nlm.nih.gov/pubmed/25300984

Reference 1. Maravilla KR, Smith MP, Vymazal J, Goyal M, Herman M, Baima JJ, Babbel R, Vaneckova M, Zižka J, Colosimo C, Urbańczyk-Zawadzka M, Mechl M, Bag AK, Bastianello S, Bueltmann E, Hirai T, Frattini T, Kirchin MA, Pirovano G. Are There Differences between Macrocyclic Gadolinium Contrast Agents for Brain Tumor Imaging? Results of a Multicenter Intraindividual Crossover Comparison of Gadobutrol with Gadoteridol (the TRUTH Study). AJNR Am J Neuroradiol. 2014 Oct 9. [Epub ahead of print]

 

REFERENCES: 1. Idee JM, Port C, Raynal I, et al. Clinical and biological consequences of transmetallation induced by contrast agents for magnetic resonance imaging: a review. Fundamental and Clinical Pharmacology. 2006; 20:563-576. 2. Postmarketing Surveillance and Utilization Report 2010. On file, Bracco Diagnostics Inc. 3. Prince MR, Erel HE, Lent RW, et al. Gadodiamide administration causes spurious hypocalcemia. Radiology. 2003; 227,(3): 639-646. 4. ProHance (gadoteridol) injection 279.3 mg/mL full Prescribing Information. Princeton, NJ: Bracco Diagnostics Inc.; Sept 2011.

Prohance

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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.

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