DrugLib.com — Drug Information Portal

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

Ablavar (Gadofosveset Trisodium) - Summary

 
 



WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)

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 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 ABLAVAR dose and allow a sufficient period of time for elimination of the drug from the body prior to re-administration [see Warnings and Precautions ].
 

ABLAVAR SUMMARY

Ablavar (gadofosveset trisodium) Injection is a sterile, nonpyrogenic, formulation of a stable gadolinium diethylenetriaminepentaacetic acid (GdDTPA) chelate derivative with a diphenylcyclohexylphosphate group. Each mL of Ablavar Injection contains 244 mg of gadofosveset trisodium (0.25 mmol), 0.268 mg of fosveset, and water for injection.

Ablavar is indicated for use as a contrast agent in magnetic resonance angiography (MRA) to evaluate aortoiliac occlusive disease (AIOD) in adults with known or suspected peripheral vascular disease.
See all Ablavar indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Ablavar (Gadofosveset)

FDA approves new diagnostic imaging agent to detect recurrent prostate cancer
Source: Prostate / Prostate Cancer News From Medical News Today [2016.05.31]
The U.S. Food and Drug Administration has approved Axumin, a radioactive diagnostic agent for injection.

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.

Artificial enzymes used in wide range of household products are "potent allergens"
Source: Allergy News From Medical News Today [2016.09.22]
But no commercially available diagnostic tests to monitor this potential new health risk.

Molecular Testing of Cancers: 'Let's Try to Get It Right'
Source: Medscape Internal Medicine Headlines [2016.09.21]
Use of molecular diagnostics in cancer can be tricky, but Dr Lundberg says the pathologist can ask important questions to help guide the process.
Medscape Internal Medicine

Prenatal Ultrasound Tied to Autism Severity in At-Risk Kids
Source: Medscape Psychiatry & Mental Health Headlines [2016.09.21]
First-trimester diagnostic ultrasound has been linked to greater autism symptom severity, particularly in genetically vulnerable boys.
Medscape Medical News

more news >>

Published Studies Related to Ablavar (Gadofosveset)

Contrast-enhanced whole-heart MR coronary angiography at 3.0 T using the intravascular contrast agent gadofosveset. [2009.07]
OBJECTIVES: The purpose of this study was to compare contrast-enhanced (CE) whole-heart coronary magnetic resonance angiography (MRA) at 3.0 T using gadofosveset to noncontrast-enhanced steady-state free precession (SSFP) coronary MRA at 1.5 T... CONCLUSIONS: CE whole-heart coronary MRA at 3.0 T demonstrated higher overall CNR between coronary blood and myocardium and an improved image quality of the distal coronary segments compared with noncontrast-enhanced SSFP coronary MRA at 1.5 T.

Safety and efficacy of gadofosveset-enhanced MR angiography for evaluation of pedal arterial disease: multicenter comparative phase 3 study. [2008.01]
CONCLUSION: Because of markedly better efficacy than no contrast agent and a minimal and transient side-effect profile, 0.03 mmol/kg of gadofosveset was found safe and effective for MR angiography of patients with pedal arterial disease.

Contrast-enhanced MRA of the renal and aorto-iliac-femoral arteries: comparison of gadobenate dimeglumine and gadofosveset trisodium. [2011.02]
RATIONALE AND OBJECTIVES: Dedicated contrast agents are now available for contrast-enhanced magnetic resonance angiography (CE-MRA). This study retrospectively compares the safety and diagnostic performance data from Phase III regulatory trials performed to evaluate gadobenate dimeglumine (MultiHance((R))) and gadofosveset trisodium (Vasovist(R))) for renal and peripheral CE-MRA... CONCLUSION: The diagnostic performance of CE-MRA for the detection of significant steno-occlusive disease is similar with gadofosveset and gadobenate dimeglumine although the rate of adverse events appears higher with gadofosveset. Copyright (c) 2009 Elsevier Ireland Ltd. All rights reserved.

CMR assessment of endothelial damage and angiogenesis in porcine coronary arteries using gadofosveset. [2011.01.26]
CONCLUSION: Contrast enhanced coronary CMR with gadofosveset can detect experimentally induced endothelial damage and angiogenesis in the porcine coronary artery wall.

Diffusion magnetic resonance imaging with gadofosveset trisodium as a negative contrast agent for lymph node metastases assessment. [2011.01]
PURPOSE: The aim of this study was to assess the feasibility of using intravenously administered gadofosveset trisodium as a negative contrast agent for lymph node (LN) assessment with diffusion-weighted imaging (DWI) using a VX2 tumor model in rabbits... CONCLUSION: The SI of metastatic LNs at DWI is less suppressed than that of nonmetastatic LNs after the intravenous administration of gadofosveset trisodium. Therefore, intravenously administered gadofosveset trisodium shows promise for use as a negative contrast agent for discriminating metastatic from nonmetastatic LNs at DWI.

more studies >>

Clinical Trials Related to Ablavar (Gadofosveset)

Pulmonary MR Angiography and Lower Extremity MR Venous Imaging Using Gadofosveset (Ablavar) [Completed]
The use of the contrast agent, Ablavar, will help with the diagnosis of pulmonary embolism in magnetic resonance imaging (MRI).

Dose-varied Evaluation of Ablavar-enhanced MR Angiography of the Central Veins of the Chest in Healthy Participants [Completed]
The purpose of this study is to assess the image quality of Ablavar-enhanced MR angiography of the central veins of the chest, and to determine whether dose reduction can be performed while maintaining image quality. This will be a prospective randomized study, in which healthy volunteers will be recruited to undergo a central veins magnetic resonance angiogram (MRA). They will receive either the FDA-approved dose or a lower dose of Ablavar. Quantitative and qualitative analysis will be performed on the images.

Prospective Evaluation of the Incidence of NSF in Patients With Kidney Disease Undergoing MR [Completed]
Phase 4, open-label, two-year, prospective, multi-center, follow-up study conducted at up 15 sites in USA. Approximately 1,000 patients with moderate-to-severe CKD will be enrolled and followed for up to 24 months.

Gadofosveset Trisodium (Ablavar, Gdfos) in Distinguishing Hemangiomas and Metastases: A Prospective Trial [Recruiting]

Magnetic Resonance Imaging for Lymph Node Staging in Ovarian Cancer [Not yet recruiting]
Advanced epithelial ovarian cancer has high morbidity and mortality. Patients presenting with advanced stage ovarian cancer often have cancer spread to regional lymph nodes. Imaging strategies to depict involved lymph nodes are currently not successful. The purpose of this study is to evaluate if magnetic resonance imaging (MRI) with gadofosveset trisodium contrast enhancement (GDF-MRI) and diffusion weighted imaging (DW-MRI) is able to identify involved lymph nodes in a preoperative setting. This could guide the surgeon during surgery to dissect lymph nodes which could lead to an optimal diagnosis/staging with the lowest possible morbidity. We want to determine the optimal imaging settings and feasibility of MRI for the detection of pathological lymph nodes in women with advanced (FIGO stage IIB-IV) ovarian cancer undergoing primary debulking surgery and compare this to conventional imaging with computer tomography (CT).

more trials >>


Page last updated: 2016-09-22

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

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