Drug Detail:Vasovist (Gadofosveset trisodium [ gad-oh-fos-ve-set-trye-soe-dee-um ])
Drug Class: Magnetic resonance imaging contrast media
Magnetic resonance angiography (MRA) :
0.12 mL/kg body weight (0.03 mmol/kg by intravenous bolus, manually or by power injection, over a period of time up to 30 seconds followed by a 25 to 30 mL normal saline flush.
Imaging is performed in two stages, the dynamic stage which begins immediately following injection and the steady-state stage, which begins following dynamic imaging; generally 5 to 7 minutes after injection.
Administration of gadolinium based contrast agents to patients with severe renal insufficiency increases the risk for NSF. Administration of these agents to patients with mild to moderate renal insufficiency may increase the risk for worsened renal function. Prior to use of gadofosveset trisodium in these patients, ensure that no satisfactory diagnostic alternatives are available. In patients with moderate to severe renal impairment (glomerular filtration rate less than 60 mL/kg/meter squared), administer gadofosveset trisodium at a dose of 0.01 mmol/kg to 0.02 mmol/kg. Consider follow-up renal function assessments following gadofosveset trisodium administration to any patients with renal insufficiency.
The pharmacokinetics and plasma protein binding of gadofosveset was not significantly influenced by moderate hepatic impairment. A slight decrease in fecal elimination of gadofosveset was seen for the hepatic impaired subjects (2.7%) compared to normal subjects (4.8%).
Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).
Gadofosveset is removed from the body by hemodialysis using high-flux filters. Elimination of the total administered dose of gadolinium in dialysate over 3 dialysis sessions using high-flux filters averaged 46.8%, 12.9%, and 6.11% for the first, second, and third sessions, respectively.