Bracco Diagnostics Inc.
Princeton, NJ 08543
by Nycomed GmbH - 78224 Singen (Germany)
Revised September 2007
WARNING: NEPHROGENIC SYSTEMIC FIBROSIS
Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis (NSF) in patients with:
- acute or chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2), or
- acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.
In these patients, avoid 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 and 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 for elimination of the agent from the body prior to any readministration (See WARNINGS).
(Gadoteridol) Injection, 279.3 mg/mL
Pharmacy Bulk Package - Not for Direct Infusion
ProHance (Gadoteridol) Injection is a nonionic contrast medium for magnetic resonance imaging (MRI), available as a 0.5M sterile clear colorless to slightly yellow aqueous solution for intravenous injection. Each vial is to be used as a Pharmacy Bulk Package for dispensing multiple single dose preparations utilizing a suitable transfer device.
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.
ProHance is indicated for use in MRI in adults to visualize lesions in the head and neck.
Media Articles Related to Prohance Multipack (Gadoteridol)
Depression or Dementia? Imaging May Solve Diagnostic Dilemma
Source: Medscape Pathology & Lab Medicine Headlines [2017.02.22]
Decreased blood flow in specific regions of the brain seen on brain imaging may help differentiate between depression and cognitive disorders, new research suggests. But questions remain.
Medscape Medical News
Advances in Companion Diagnostics Congress - Pre-Congress Live Webinars: Register For Free
Source: Conferences News From Medical News Today [2017.02.10]
Pre-Congress Live Webinars: Register For Free 'Challenges in Developing Companion Diagnostics for Cancer and Immunology'Tuesday 14th February - 3.00 pm GMTCan't make the date?
Flexible future of point-of-care disease diagnostic
Source: Bird Flu / Avian Flu News From Medical News Today [2015.07.29]
The world-wide deployment of biomedical devices for health monitoring, point-of-care diagnostics and environmental sensing is hampered by their high cost that is not readily affordable for e.g.
Chronic Diarrhea: Diagnosis and Management
Source: Medscape Allergy & Clinical Immunology Headlines [2017.02.24]
There are many diverse causes of chronic diarrhea. Learn when imaging studies or other diagnostic test are appropriate, and how management should be approached, in this primer.
Clinical Gastroenterology and Hepatology
Stereotactic Breast Biopsy: What Happens, Results, and Outlook
Source: Radiology / Nuclear Medicine News From Medical News Today [2016.11.17]
Learn about stereotactic breast biopsies, their benefits, and what they are used for. This article describes what to expect with this diagnostic procedure.
Published Studies Related to Prohance Multipack (Gadoteridol)
Magnetic resonance evaluation of brain metastases from systemic malignances with two doses of gadobutrol 1.0 m compared with gadoteridol: a multicenter, phase ii/iii study in patients with known or suspected brain metastases. [2011.07]
OBJECTIVES: To determine the efficacy and safety of 2 doses of gadobutrol 1.0 M (0.1 and 0.2 mmol/kg body weight [BW]), compared with gadoteridol 0.5 M (0.2 mmol/kg BW), in contrast-enhanced magnetic resonance imaging (CE-MRI) of brain metastases in patients with known or suspected brain metastases from systemic malignancies. The study also compared the usefulness of gadobutrol in treatment planning for stereotactic radiosurgery (SRS)... CONCLUSION: In this study, a single dose of gadobutrol was shown to be noninferior to a double dose of gadoteridol at detecting brain metastases, and could be effectively used for treatment planning in patients eligible for SRS. A dose of gadobutrol 0.1 mmol/kg BW is recommended as the clinical dose for the detection of brain metastases.
Magnetic resonance evaluation of brain metastases from systemic malignances with
two doses of gadobutrol 1.0 m compared with gadoteridol: a multicenter, phase
ii/iii study in patients with known or suspected brain metastases. 
planning for stereotactic radiosurgery (SRS)... CONCLUSION: In this study, a single dose of gadobutrol was shown to be
Risk for nephrogenic systemic fibrosis with gadoteridol (ProHance) in patients who are on long-term hemodialysis. [2008.05]
BACKGROUND AND OBJECTIVES: Recent studies strongly link nephrogenic systemic fibrosis to gadolinium administration for magnetic resonance imaging. In a recent advisory, the Food and Drug Administration stated that all gadolinium-containing chelates are potentially associated with nephrogenic systemic fibrosis; however, most reported cases are linked to gadodiamide (Omniscan) and gadopentetate dimeglumine (Magnevist). Given the severe consequences of nephrogenic systemic fibrosis, it is critical to define the risks associated with each gadolinium-containing chelate. The purpose of this study was to examine nephrogenic systemic fibrosis risk in a hemodialysis population exposed to gadoteridol (ProHance)... CONCLUSIONS: It is concluded that the risk for nephrogenic systemic fibrosis with gadoteridol in patients who are on long-term hemodialysis may be lower than with gadodiamide and gadopentetate dimeglumine.
Page last updated: 2017-02-24