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Vasovist
Overview
What is Vasovist?
VASOVIST (gadofosveset trisodium) Injection is a sterile, nonpyrogenic, formulation of a stable gadolinium diethylenetriaminepentaacetic acid (GdDTPA) chelate derivative with a diphenylcyclohexylphosphate group. Each mL of VASOVIST Injection contains 244 mg of gadofosveset trisodium (0.25 mmol), 0.27 mg of fosveset, and water for injection.
It contains no preservative and the solution pH ranges between 6.5 to 8.0.
Gadofosveset trisodium is chemically trisodium-{(2-(R)-[(4,4-diphenylcyclohexyl) phosphonooxymethyl]-diethylenetriaminepentaacetato)(aquo) gadolinium(III),with a molecular weight of 975.88 g/mol, and an empirical formula of CHGdNNaOP. It has a structural formula:
Pertinent physiochemical data of VASOVIST Injection are provided below:
What does Vasovist look like?
What are the available doses of Vasovist?
Each mL of VASOVIST Injection contains 244 mg gadofosveset trisodium (equivalent to 0.25 mmol/mL) and is available in single-use vials ().
What should I talk to my health care provider before I take Vasovist?
How should I use Vasovist?
VASOVIST 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 []
Administer VASOVIST as an intravenous bolus injection, manually or by power injection, at a dose of 0.12 mL/kg body weight (0.03 mmol/kg) over a period of time up to 30 seconds followed by a 25-30 mL normal saline flush. (See for weight-adjusted dose volumes).
Inspect the VASOVIST vial visually for particulate matter and discoloration prior to administration. Do not use the solution if it is discolored or particulate matter is present.
VASOVIST is intended for single use only and should be used immediately upon opening. Discard any unused portion of the VASOVIST vial.
Do not mix intravenous medications or parenteral nutrition solutions with VASOVIST. Do not administer any other medications in the same intravenous line simultaneously with VASOVIST.
What interacts with Vasovist?
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What are the warnings of Vasovist?
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What are the precautions of Vasovist?
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What are the side effects of Vasovist?
Sorry No records found
What should I look out for while using Vasovist?
History of a prior allergic reaction to a gadolinium-based contrast agent.
Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis (NSF) in patients with:
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 re-administration []
What might happen if I take too much Vasovist?
VASOVIST Injection has been administered to humans up to a dose of 0.15 mmol/kg (5 times the clinical dose). No VASOVIST overdoses were reported in clinical trials. In the event of an overdose, direct treatment toward the support of all vital functions and prompt institution of symptomatic therapy. Gadofosveset has been shown to be removed by hemodialysis using a high flux dialysis procedure [].
How should I store and handle Vasovist?
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].VASOVIST Injection is a sterile, clear, colorless to pale yellow solution containing 244 mg/mL (0.25 mmol/mL) of gadofosveset trisodium in rubber-stoppered vials with an aluminum seal. VASOVIST Injection is supplied as follows:
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Following intravenous injection, gadofosveset binds reversibly to endogenous serum albumin resulting in longer vascular residence time than non-protein binding contrast agents. The binding to serum albumin also increases the magnetic resonance relaxivity of gadofosveset and decreases the relaxation time (T1) of water protons resulting in an increase in signal intensity (brightness) of blood.
Non-Clinical Toxicology
History of a prior allergic reaction to a gadolinium-based contrast agent.Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis (NSF) in patients with:
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 re-administration []
Oral metronidazole has been reported to potentiate the anticoagulant effect of coumarin and warfarin resulting in a prolongation of prothrombin time. Drug interactions should be kept in mind when is prescribed for patients who are receiving anticoagulant treatment, although they are less likely to occur with topical metronidazole administration because of low absorption. (See , section)
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/1.73m) and in patients with 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 MRA. For patients receiving hemodialysis, physicians may consider the prompt initiation of hemodialysis following the administration of a gadolinium-based contrast agent in order to enhance the contrast agent's elimination. VASOVIST binds to blood albumin and use of a high-flux dialysis procedure is essential to optimized VASOVIST elimination in patients receiving chronic hemodialysis. The usefulness of hemodialysis in the prevention of NSF is unknown [].
Among the factors that may increase the risk for NSF are repeated or higher than recommended doses of a gadolinium-based contrast agent and the degree of renal function impairment at the time of exposure.
Post-marketing reports have identified the development of NSF following single and multiple administrations of gadolinium-based contrast agents. These reports have not always identified a specific agent. Prior to marketing of Vasovist®, where a specific agent was identified, the most commonly reported agent was gadodiamide (Omniscan), followed by gadopentetate dimeglumine (Magnevist) and gadoversetamide (OptiMARK). NSF has also developed following sequential administrations of gadodiamide with gadobenate dimeglumine (MultiHance) or gadoteridol (ProHance). The number of post-marketing reports is subject to change over time and may not reflect the true proportion of cases associated with any specific gadolinium-based contrast agent.
The extent of risk for NSF following exposure to any specific gadolinium-based contrast agent is unknown and may vary among the agents. Published reports are limited and predominantly estimate NSF risks with gadodiamide. In one retrospective study of 370 patients with severe renal insufficiency who received gadodiamide, the estimated risk for development of NSF was 4% (J Am Soc Nephrol 2006; 17:2359). The risk, if any, for the development of NSF among patients with mild to moderate renal insufficiency or normal renal function is unknown.
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 prior to any re-administration. NSF was not reported in clinical trials of VASOVIST [].
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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