DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Prohance (Gadoteridol) - Summary

 
 



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).
 

PROHANCE SUMMARY

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 in vials and syringes for intravenous injection.

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.


See all Prohance indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Prohance (Gadoteridol)

ESC: Diagnostic Testing in the Spotlight
Source: MedPage Today Cardiovascular [2015.08.27]
(MedPage Today) -- HS-troponin I and CT-based fractional flow reserve among top trials expected

New Coalition to Tackle Diagnostic Errors in Medicine
Source: Medscape Business of Medicine Headlines [2015.08.26]
The Coalition to Improve Diagnosis will shine a light on diagnostic errors in medicine and find ways to curb the problem, organizers say.
Medscape Medical News

Biocept launches its first liquid biopsy diagnostic test for colorectal cancer
Source: Colorectal Cancer News From Medical News Today [2015.08.25]
New test uses patient's blood sample to detect KRAS, predictive biomarker for solid tumor cancersBiocept, Inc.

New diagnostic tools for dehydration severity in children
Source: GastroIntestinal / Gastroenterology News From Medical News Today [2015.08.21]
System may improve intake of cholera, diarrhea casesDehydration from diarrhea, either from viral infection or cholera, accounts for 10 percent of all child deaths worldwide.

Novel diagnostic tool for ethnically diverse non-small-cell lung cancer patients
Source: Lung Cancer News From Medical News Today [2015.08.17]
A new serum miRNA panel could lead to accurately and early diagnosing NSCLC in ethnically diverse patientsEarly-stage Non-small-cell Lung Cancer (NSCLC) is asymptomatic and difficult to detect...

more news >>

Published Studies Related to Prohance (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. [2011]
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.

more studies >>

Reports of Suspected Prohance (Gadoteridol) Side Effects

Nephrogenic Systemic Fibrosis (114)Pain (90)Skin Induration (65)Mobility Decreased (63)Anxiety (59)Skin Tightness (56)Joint Range of Motion Decreased (53)Oedema Peripheral (51)Emotional Distress (51)Skin Hypertrophy (46)more >>


Page last updated: 2015-08-27

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2015