Vasovist

VASOVIST
(gadofosveset trisodium) Injection for Intravenous Use

WARNING

NEPHROGENIC SYSTEMIC FIBROSIS (NSF)

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), or
  • 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 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]

DRUG DESCRIPTION

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 C33H40GdN3Na3O15P. It has a structural formula:

VASOVIST (gadofosveset trisodium) Structural Formula Illustration

Pertinent physiochemical data of VASOVIST (gadofosveset trisodium injection for intravenous use) Injection are provided below:

Table 3. Physiochemical Characteristics

Parameter Condition Value
Osmolality (mOsmol/kg water) @ 37°C 825
Viscosity (cP) @ 20°C 3.0
Density (g/mL) @ 25°C 1.1224

What are the possible side effects of gadofosveset trisodium (Ablavar)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • urinating less than usual or not at all;
  • drowsiness, confusion, mood changes, increased thirst, loss of appetite;
  • swelling, weight gain, feeling short of breath; or
  • fast, uneven heart rate.

Less serious side effects may include:

  • headache, dizziness;
  • nausea;
  • flushing...

Read All Potential Side Effects and See Pictures of Vasovist »

Last reviewed on RxList: 10/5/2009
This monograph has been modified to include the generic and brand name in many instances.

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