Gadofosveset Trisodium (1 brand name, 1 dosage form, 1 route)
Available dosage forms: SOLUTION.
Routes of administration: INTRAVENOUS.
Brand Names
- ABLAVAR
Boxed Warning
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), oracute 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 re-administration [see Warnings and Precautions (5.1)]
Indications and Usage
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 [see Clinical Studies (14)].
Contraindications
History of a prior allergic reaction to a gadolinium-based contrast agent.
Adverse Reactions
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.
Drug Interactions
Following injection, VASOVIST binds to blood albumin and has the potential to alter the binding of other drugs that also bind to albumin. No drug interaction reactions were observed in clinical trials. Consider the possibility of VASOVIST interaction with concomitantly administered medications that bind to albumin. An interaction may enhance or decrease the activity of the concomitant medication [see Clinical Pharmacology (12.3)].
Mechanism of Action
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.
Overdosage
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 [see Clinical Pharmacology (12.3)].